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G.R. No. 185565, November 26, 2014 - LOADSTAR SHIPPING COMPANY, INCORPORATED AND LOADSTAR INTERNATIONAL SHIPPING COMPANY, INCORPORATED, Petitioners, v. MALAYAN INSURANCE COMPANY, INCORPORATED, Respondent.
LOADSTAR SHIPPING COMPANY, INCORPORATED AND LOADSTAR INTERNATIONAL SHIPPING COMPANY, INCORPORATED, Petitioners, v. MALAYAN INSURANCE COMPANY, INCORPORATED, Respondent.
This is a Petition for Review on Certiorari1 filed by Loadstar Shipping Company, Incorporated and Loadstar International Shipping Company, Incorporated (petitioners) against Malayan Insurance Company, Incorporated (Malayan) seeking to set aside the Decision2 dated April 14, 2008 and Resolution3 dated December 11, 2008 of the Court of Appeals (CA) in CA-G.R. CV No. 82758, which reversed and set aside the Decision4 dated March 31, 2004 of the Regional Trial Court of Manila, Branch 34, in Civil Case No. 01-101885.
Loadstar International Shipping, Inc. (Loadstar Shipping) and Philippine Associated Smelting and Refining Corporation (PASAR) entered into a Contract of Affreightment for domestic bulk transport of the latter’s copper concentrates for a period of one year from November 1, 1998 to October 31, 1999. The contract was extended up to the end of October 2000.
On September 10, 2000, 5,065.47 wet metric tons (WMT) of copper concentrates were loaded in Cargo Hold Nos. 1 and 2 of MV “Bobcat”, a marine vessel owned by Loadstar International Shipping Co., Inc. (Loadstar International) and operated by Loadstar Shipping under a charter party agreement. The shipper and consignee under the Bill of Lading are Philex Mining Corporation (Philex) and PASAR, respectively. The cargo was insured with Malayan Insurance Company, Inc. (Malayan) under Open Policy No. M/OP/2000/001-582. P & I Association is the third party liability insurer of Loadstar Shipping.
On said date (September 10, 2000), MV “Bobcat” sailed from Poro Point, San Fernando, La Union bound for Isabel, Leyte. On September 12, 2000, while in the vicinity of Cresta de Gallo, the vessel’s chief officer on routine inspection found a crack on starboard side of the main deck which caused seawater to enter and wet the cargo inside Cargo Hold No. 2 forward/aft. The cracks at the top deck starboard side of Cargo Hold No. 2, measuring 1.21 meters long x 0.39 meters wide, and at top deck aft section starboard side on other point, measuring 0.82 meters long x 0.32 meters wide, were welded.
Immediately after the vessel arrived at Isabel, Leyte anchorage area, on September 13, 2000, PASAR and Philex’s representatives boarded and inspected the vessel and undertook sampling of the copper concentrates. In its preliminary report dated September 15, 2000, the Elite Adjusters and Surveyor, Inc. (Elite Surveyor) confirmed that samples of copper concentrates from Cargo Hold No. 2 were contaminated by seawater. Consequently, PASAR rejected 750 MT of the 2,300 MT cargo discharged from Cargo Hold No. 2.
On November 6, 2000, PASAR sent a formal notice of claim in the amount of [P]37,477,361.31 to Loadstar Shipping. In its final report dated November 16, 2000, Elite Surveyor recommended payment to the assured the amount of [P]32,351,102.32 as adjusted. On the basis of such recommendation, Malayan paid PASAR the amount of [P]32,351,102.32.
Meanwhile, on November 24, 2000, Malayan wrote Loadstar Shipping informing the latter of a prospective buyer for the damaged copper concentrates and the opportunity to nominate/refer other salvage buyers to PASAR. On November 29, 2000, Malayan wrote Loadstar Shipping informing the latter of the acceptance of PASAR’s proposal to take the damaged copper concentrates at a residual value of US$90,000.00. On December 9, 2000, Loadstar Shipping wrote Malayan requesting for the reversal of its decision to accept PASAR’s proposal and the conduct of a public bidding to allow Loadstar Shipping to match or top PASAR’s bid by 10%.
On January 23, 2001, PASAR signed a subrogation receipt in favor of Malayan. To recover the amount paid and in the exercise of its right of subrogation, Malayan demanded reimbursement from Loadstar Shipping, which refused to comply. Consequently, on September 19, 2001, Malayan instituted with the RTC a complaint for damages. The complaint was later amended to include Loadstar International as party defendant.
In its amended complaint, Malayan mainly alleged that as a direct and natural consequence of the unseaworthiness of the vessel, PASAR suffered loss of the cargo. It prayed for the amount of [P]33,934,948.75, representing actual damages plus legal interest from date of filing of the complaint until fully paid, and attorney’s fees in the amount of not less than [P]500,000.00. It also sought to declare the bill of lading as void since it violates the provisions of Articles 1734 and 1745 of the Civil Code.
On October 30, 2002, Loadstar Shipping and Loadstar International filed their answer with counterclaim, denying plaintiff-appellant’s allegations and averring as follows: that they are not engaged in the business as common carriers but as private carriers; that the vessel was seaworthy and defendants-appellees exercised the required diligence under the law; that the entry of water into Cargo Hold No. 2 must have been caused by force majeure or heavy weather; that due to the inherent nature of the cargo and the use of water in its production process, the same cannot be considered damaged or contaminated; that defendants-appellees were denied reasonable opportunity to participate in the salvage sale; that the claim had prescribed in accordance with the bill of lading provisions and the Code of Commerce; that plaintiff-appellant’s claim is excessive, grossly overstated, unreasonable and unsubstantiated; that their liability, if any, should not exceed the CIF value of the lost/damaged cargo as set forth in the bill of lading, charter party or customary rules of trade; and that the arbitration clause in the contract of affreightment should be followed.
After trial, and considering that the bill of lading, which was marked as Exhibit “B”, is unreadable, the RTC issued on February 17, 2004 an order directing the counsel for Malayan to furnish it with a clearer copy of the same within three (3) days from receipt of the order. On February 23, 2004, Malayan filed a compliance attaching thereto copy of the bill of lading.
On March 31, 2004, the RTC rendered a judgment dismissing the complaint as well as the counterclaim. The RTC was convinced that the vessel was seaworthy at the time of loading and that the damage was attributable to the perils of the sea (natural disaster) and not due to the fault or negligence of Loadstar Shipping.
The RTC found that although contaminated by seawater, the copper concentrates can still be used. It gave credence to the testimony of Francisco Esguerra, defendants-appellees’ expert witness, that despite high chlorine content, the copper concentrates remain intact and will not lose their value. The gold and silver remain with the grains/concentrates even if soaked with seawater and does not melt. The RTC observed that the purchase agreement between PASAR and Philex contains a penalty clause and has no rejection clause. Despite this agreement, the parties failed to sit down and assess the penalty.
The RTC also found that defendants-appellees were not afforded the opportunity to object or participate or nominate a participant in the sale of the contaminated copper concentrates to lessen the damages to be paid. No record was presented to show that a public bidding was conducted. Malayan sold the contaminated copper concentrates to PASAR at a low price then paid PASAR the total value of the damaged concentrate without deducting anything from the claim.
WHEREFORE, the appeal is GRANTED. The Decision dated March 31, 2004 of the RTC, Branch 34, Manila in Civil Case No. 01-101885, is REVERSED and SET ASIDE. In lieu thereof, a new judgment is entered, ORDERING defendants-appellees to pay plaintiff-appellant P33,934,948.75 as actual damages, plus legal interest at 6% annually from the date of the trial court’s decision. Upon the finality of the decision, the total amount of the judgment shall earn annual interest at 12% until full payment.
WHEREFORE, the Motion for Reconsideration is PARTLY GRANTED. The decision of this Court dated April 14, 2008 is PARTIALLY RECONSIDERED and MODIFIED. Defendants-appellees are ORDERED to pay to plaintiff-appellant P33,934,948.74 as actual damages, less US$90,000.00, computed at the exchange rate prevailing on November 29, 2000, plus legal interest at 6% annually from the date of the trial court’s decision. Upon the finality of the decision, the total amount of the judgment shall earn annual interest at 12% until full payment.
It is not disputed that the copper concentrates carried by M/V Bobcat from Poro Point, La Union to Isabel, Leyte were indeed contaminated with seawater. The issue lies on whether such contamination resulted to damage, and the costs thereof, if any, incurred by the insured PASAR.
On this score, the Court agrees with Malayan that contrary to the trial court’s disquisition, the petitioners cannot validly invoke the penalty clause under the Philex-PASAR purchase agreement, where penalties are to be imposed by the buyer PASAR against the seller Philex if some elements exceeding the agreed limitations are found on the copper concentrates upon delivery. The petitioners are not privy to the contract of sale of the copper concentrates. The contract between PASAR and the petitioners is a contract of carriage of goods and not a contract of sale. Therefore, the petitioners and PASAR are bound by the laws on transportation of goods and their contract of affreightment. Since the Contract of Affreightment17 between the petitioners and PASAR is silent as regards the computation of damages, whereas the bill of lading presented before the trial court is undecipherable, the New Civil Code and the Code of Commerce shall govern the contract between the parties.
Based on the preceding computation, the sum of P32,315,312.32 represents damages for the total loss of that portion of the cargo which were contaminated with seawater and not merely the depreciation in its value. Strangely though, after claiming damages for the total loss of that portion, PASAR bought back the contaminated copper concentrates from Malayan at the price of US$90,000.00. The fact of repurchase is enough to conclude that the contamination of the copper concentrates cannot be considered as total loss on the part of PASAR.
Article 361. The merchandise shall be transported at the risk and venture of the shipper, if the contrary has not been expressly stipulated. As a consequence, all the losses and deteriorations which the goods may suffer during the transportation by reason of fortuitous event, force majeure, or the inherent nature and defect of the goods, shall be for the account and risk of the shipper. Proof of these accidents is incumbent upon the carrier.
Article 362. Nevertheless, the carrier shall be liable for the losses and damages resulting from the causes mentioned in the preceding article if it is proved, as against him, that they arose through his negligence or by reason of his having failed to take the precautions which usage has established among careful persons, unless the shipper has committed fraud in the bill of lading, representing the goods to be of a kind or quality different from what they really were.
Article 364. If the effect of the damage referred to in Article 361 is merely a diminution in the value of the goods, the obligation of the carrier shall be reduced to the payment of the amount which, in the judgment of experts, constitutes such difference in value.
Article 365. If, in consequence of the damage, the goods are rendered useless for sale and consumption for the purposes for which they are properly destined, the consignee shall not be bound to receive them, and he may have them in the hands of the carrier, demanding of the latter their value at the current price on that day.
If among the damaged goods there should be some pieces in good condition and without any defect, the foregoing provision shall be applicable with respect to those damaged and the consignee shall receive those which are sound, this segregation to be made by distinct and separate pieces and without dividing a single object, unless the consignee proves the impossibility of conveniently making use of them in this form.
The same rule shall be applied to merchandise in bales or packages, separating those parcels which appear sound.
From the above-cited provisions, if the goods are delivered but arrived at the destination in damaged condition, the remedies to be pursued by the consignee depend on the extent of damage on the goods.
If the goods are rendered useless for sale, consumption or for the intended purpose, the consignee may reject the goods and demand the payment of such goods at their market price on that day pursuant to Article 365. In case the damaged portion of the goods can be segregated from those delivered in good condition, the consignee may reject those in damaged condition and accept merely those which are in good condition. But if the consignee is able to prove that it is impossible to use those goods which were delivered in good condition without the others, then the entire shipment may be rejected. To reiterate, under Article 365, the nature of damage must be such that the goods are rendered useless for sale, consumption or intended purpose for the consignee to be able to validly reject them.
If the effect of damage on the goods consisted merely of diminution in value, the carrier is bound to pay only the difference between its price on that day and its depreciated value as provided under Article 364.
Malayan, as the insurer of PASAR, neither stated nor proved that the goods are rendered useless or unfit for the purpose intended by PASAR due to contamination with seawater. Hence, there is no basis for the goods’ rejection under Article 365 of the Code of Commerce. Clearly, it is erroneous for Malayan to reimburse PASAR as though the latter suffered from total loss of goods in the absence of proof that PASAR sustained such kind of loss. Otherwise, there will be no difference in the indemnification of goods which were not delivered at all; or delivered but rendered useless, compared against those which were delivered albeit, there is diminution in value.
Malayan also failed to establish the legal basis of its decision to sell back the rejected copper concentrates to PASAR. It cannot be ascertained how and when Malayan deemed itself as the owner of the rejected copper concentrates to have these validly disposed of. If the goods were rejected, it only means there was no acceptance on the part of PASAR from the carrier. Furthermore, PASAR and Malayan simply agreed on the purchase price of US$90,000.00 without any allegation or proof that the said price was the depreciated value based on the appraisal of experts as provided under Article 364 of the Code of Commerce.
Art. 2207. If the plaintiff’s property has been insured, and he has received indemnity from the insurance company for the injury or loss arising out of the wrong or breach of contract complained of, the insurance company shall be subrogated to the rights of the insured against the wrongdoer or the person who has violated the contract. If the amount paid by the insurance company does not fully cover the injury or loss, the aggrieved party shall be entitled to recover the deficiency from the person causing the loss or injury.
Consequently, an insurer indemnifies the insured based on the loss or injury the latter actually suffered from. If there is no loss or injury, then there is no obligation on the part of the insurer to indemnify the insured. Should the insurer pay the insured and it turns out that indemnification is not due, or if due, the amount paid is excessive, the insurer takes the risk of not being able to seek recompense from the alleged wrongdoer. This is because the supposed subrogor did not possess the right to be indemnified and therefore, no right to collect is passed on to the subrogee.
Whereas the CA modified its Decision dated April 14, 2008 by deducting the amount of US$90,000.00 from the award, the same is still iniquitous for the petitioners because PASAR and Malayan never proved the actual damages sustained by PASAR. It is a flawed notion to merely accept that the salvage value of the goods is US$90,000.00, since the price was arbitrarily fixed between PASAR and Malayan. Actual damages to PASAR, for example, could include the diminution in value as appraised by experts or the expenses which PASAR incurred for the restoration of the copper concentrates to its former condition, if there is damage and rectification is still possible.
It is also noteworthy that when the expert witness for the petitioners, Engineer Francisco Esguerra (Esguerra), testified as regards the lack of any adverse effect of seawater on copper concentrates, Malayan never presented evidence of its own in refutation to Esguerra’s testimony. And, even if the Court will disregard the entirety of his testimony, the effect on Malayan’s cause of action is nil. As Malayan is claiming for actual damages, it bears the burden of proof to substantiate its claim.
Having ruled that Malayan did not adduce proof of pecuniary loss to PASAR for which the latter was questionably indemnified, there is no necessity to expound further on the other issues raised by the petitioners and Malayan in this case.
WHEREFORE, the petition is GRANTED. The Decision dated April 14, 2008 and Resolution dated December 11, 2008 of the Court of Appeals in CA-G.R. CV No. 82758 are hereby REVERSED and SET ASIDE. The Decision dated March 31, 2004 of the Regional Trial Court of Manila, Branch 34 in Civil Case No. 01-101885 is REINSTATED.
2 Penned by Associate Justice Hakim S. Abdulwahid, with Associate Justices Rodrigo V. Cosico and Mariflor P. Punzalan Castillo, concurring; id. at 113-126.
4 Issued by Judge Romulo A. Lopez; id. at 184-202.
20Pan Malayan Insurance Corp. v. Court of Appeals, 262 Phil. 919, 923 (1990).
22Sulpicio Lines, Inc. v. First Lepanto-Taisho Insurance Corporation, 500 Phil. 514, 525 (2005), citing Lorenzo Shipping Corp. v. Chubb and Sons, Inc., G.R. No. 147724, June 8, 2004, 431 SCRA 266, 275.
23Mamaril v. The Boy Scout of the Philippines, G.R. No. 179382, January 14, 2013, 688 SCRA 437, 453.
24Marikina Auto Line Transport Corp. v. People, 520 Phil. 809, 825 (2006).


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Mycobacterium tuberculosis is one of the leading causes of death worldwide, and multidrug-resistant tuberculosis (MDR-TB) is associated with a high case fatality rate. Rapid identification of resistant strains is crucial for the early administration of appropriate therapy, for prevention of development of further resistance, and to curtail the spread of MDR strains. The Genotype MTBDR (Hain Lifescience, Nehren, Germany) is a reverse hybridization line probe assay designed for the rapid detection of rpoB and katG gene mutations in clinical isolates. The ability of this technique to correctly identify resistant and MDR-TB strains was tested on 206 isolates from the Italian drug resistance surveillance system. This panel included the majority of MDR strains isolated in Italy in the past 3 years. The results of the test were compared to conventional drug susceptibility test performed on isolated strains and verified by sequencing the regions of interest of the bacterial genome. The rate of concordance between the results of the MTBDR and those obtained with “in vitro” sensitivity was 91.5% (130 of 142) for rifampin and 67.1% (116 of 173) for isoniazid. We also applied this test directly to a panel of 36 clinical specimens collected from patients with active TB. The MTBDR correctly identified the two cases of MDR-TB included in the panel. These results show that the MTBDR test is useful in the detection and management of tuberculosis when MDR disease is suspected.
Drug-resistant Mycobacterium tuberculosis strains are a real threat to tuberculosis (TB) control worldwide, as strains resistant to major anti-TB drugs have emerged. Multidrug-resistant TB (MDR-TB; resistant at least to rifampin and isoniazid) requires prolonged and expensive chemotherapy, with low cure and high fatality rates (8). In several Eastern European countries economic crisis and health system weaknesses have led to an increase in the numbers of TB cases, together with the establishment of hot spots for MDR-TB. Laboratory surveillance of drug resistance and early identification of resistant strains are critical steps for the beginning of appropriate treatment. Any delay in resistant strain identification jeopardizes the efforts to control the transmission of the disease.
Rifampin (RIF) resistance is due to mutation in a relatively small fragment (81 bp) of the rpoB gene encoding for the β-subunit of the RNA polymerase (12, 29, 35); isoniazid (INH) resistance is caused by mutations in one of several regions of the katG gene, the inhA regulatory and coding region, and the ahpC-oxyR, ndh, and kasA genes (3, 4, 18, 19, 26, 29, 32, 33, 36, 39). Analysis of strains collected in different countries shows different prevalences of the mutations (24).
Easy-to-perform, rapid, and cost-effective assays based on molecular techniques that are suitable for application in clinical mycobacteriology laboratories are necessary to evaluate the presence of genomic mutations conferring resistance. Detection of resistance by conventional methods is inadequate due to the slow growth rate of M. tuberculosis; in addition, direct detection of known mutations could be more reliable in predicting the response to therapy.
The Genotype MTBDR (Hain Lifescience, Nehren, Germany) is a new commercial and easy-to-perform assay developed for the detection of RIF and/or INH resistance in TB strains. The test is based on reverse hybridization between amplicons derived from a multiplex PCR and nitrocellulose-bound wild-type and mutated probes for the mutations of interest.
The aim of the present study was to evaluate Genotype MTBDR as a rapid diagnostic tool to detect rpoB and katG gene mutations that are associated with RIF and INH resistance, respectively, in TB isolates.
We tested 206 M. tuberculosis strains isolated in Italy during the past 3 years, including 139 MDR strains and 30 fully susceptible ones. A total of 69 strains were collected from Italian patients, and 137 were obtained from foreign-born people. In order to show that the test is suitable for the direct detection on clinical specimens, we also performed the test on respiratory samples collected from active TB patients.
Strains analyzed.We analyzed 206 M. tuberculosis strains isolated in Italy from January 2002 to June 2005. This panel included 139 MDR, 30 fully susceptible, and 37 monoresistant or polyresistant (non-MDR) strains (Table 1). A total of 85% of the MDR strains were isolated from retreatment cases.
The study population represented more than 90% of the MDR strains isolated in Italy and collected during the SMIRA (for Italian Resistance Surveillance Study) project (23). A total of 69 strains were collected from native Italian patients, and 137 strains were from foreign-born people. Drug susceptibility testing for RIF and INH on TB-positive cultures was performed by using MGIT 9600 and/or radiometric Bactec 460 (Becton Dickinson Microbiology Systems, Cockeysville, MD) according to the manufacturer's instructions. The susceptibility of all strains included in the study was rechecked by a proportion method on Löwenstein-Jensen according to the SMIRA protocol (23).
Clinical specimens.Direct detection from clinical specimens was performed on a panel of 36 Amplified Mycobacterium Tuberculosis Direct test (MTD; bioMerieux, Marcy l'Etoile, France)-positive respiratory samples. A total of 32 of 36 isolates were classified as smear positive (ranging from scanty to “++”), and 4 of 36 isolates were classified as smear negative by smear microscopy performed after fluorochrome staining.
Genotypic characterization.Genomic bacterial DNA was extracted from M. tuberculosis cultures on Löwenstein-Jensen slants according to a standard protocol described elsewhere (37). The genomic regions involved in the resistant phenotype were amplified according to a previously described protocol (17) with some adjustments. Each amplification reaction contained 1.5 mM MgCl2, 0.3 mM concentrations of each deoxynucleoside triphosphate, 10 pmol of each primer, 2.5 U of HotStart Taq DNA Polymerase (QIAGEN), and 5 μl of lysate in 30 μl of distilled sterile water. Amplification was performed in a GeneAmp thermal cycler (Perkin-Elmer, Foster City, CA) beginning with 1 cycle at 95°C for 15 min (Taq activation step), followed by 30 cycles at 94°C for 1 min, 58°C for 1 min, and 72°C for 1 min, followed by a final extension at 72°C for 15 min. We sequenced the hot-spot region of the rpoB gene with the primers RpoB_r (5′-GCGGTACGGCGTTTCGATGAAC-3′), RpoB_f (5′-GGGAGCGGATGACCACCCA-3′) (17) and the N-terminal region with RpoB7R (5′-GACGGTGTCGCGCTTGTCGAC-3′), RpoB6F (5′-CGACGAGTGCAAAGACAAGGACA-3′) (2). The region of the katG gene including the S315T mutation and the mabAF-inhA operon region were sequenced with the primers KatG_r (5′-CCGGCACCGGCGCCGTCCTTG-3′); KatG_f (5′-CGGCGCATGGCCATGAACGACGTC-3′); InhA_301Rev (5′-CGATCCCCCGGTTTCCTCCG-3′), designed with pDRAW32 version 1.1.90 (Acaclone); and MabAF (5′-CGAAGTGTGCTGAGTCACACCG-3′) (13).
Direct sequencing of the PCR products was carried out with an ABI Prism 3100 capillary sequencer (Applied Biosystems, Foster City, CA) and an ABI Prism BigDye Terminator kit v. 2.1 (Applied Biosystems) according to the instructions provided by manufacturer.
Genotype MTBDR assay.The Genotype MTBDR assay is based on reverse hybridization between amplicons derived from a multiplex PCR and nitrocellulose-bound probes covering overlapping wild-type (WT) sequences of the hot-spot regions (rpoB WT 1-rpoB WT 5, katG WT), the four most frequent mutations for rpoB (rpoB MUT probes), and mutations at codon 315 in katG (katG MUT probes) (Fig. 1). The presence of a mutation is indicated by the lack of hybridization on one or more of WT probes with or without hybridization on the MUT probes. There are also a universal control (UC) that verifies the presence of amplicons derived from gram-positive bacteria with a high percentage of G+C genomic content and a specific control (TUB) for the M. tuberculosis complex isolates. After denaturation, the single-stranded biotin-labeled amplicons are hybridized to membrane-bound probes at 45°C for 30 min on a shaking water bath. The strips are washed for 15 min at 45°C according to the manufacturer's instructions, and hybridization is detected by the addition of a streptavidin-alkaline phosphatase conjugate, followed by an alkaline phosphatase substrate reaction. The results are available the same day with one-step PCR.
Schematic representation of rpoB “hot-spot region” showing the positions of wild-type and mutated probes present in the strip. The average size of the probes is 20 bases. The arrowheads indicate the numbers and positions of omitted codons.
DNA from solid and liquid cultures was extracted by thermal lysis and sonication, and the Genotype MTBDR assay was performed in accordance with the manufacturer's instructions. In brief, from solid media three to five colonies were suspended in 1 ml of sterile distilled water, and mycobacteria were lysed by incubation at 95°C for 30 min and sonication for 15 min. Tubes were centrifuged at 13,000 rpm for 10 min at 4°C, and 5 μl of lysate was used for amplification with the provided biotinylated primers. The amplification was performed in a GeneAmp System 2400 (Perkin-Elmer) thermal cycler with a protocol consisting of 1 cycle at 95°C for 15 min (Taq activation cycle), 10 cycles of denaturation at 95°C for 30 s and primer annealing at 58°C for 2 min, followed by 20 cycles of denaturation at 95°C for 25 s, primer annealing at 53°C for 40 s, and extension at 70°C for 40 s, followed finally by a final extension at 70°C for 8 min.
The molecular weight of the amplicons was verified on a 2% agarose gel as reported in the manufacturer's technical manual. Hybridization and washing were performed with a fully automated machine (APOLLO 20/2TC; MATEC Medizintecnik GmbH, Munsingen, Germany) or manually using the TWINCUBATOR hybridization tray (HAIN Lifescience, Nehren, Germany). Strips were interpreted for susceptibility or resistance to RIF and INH according to the manufacturer's instructions.
Direct detection from clinical specimens.For direct detection from clinical specimens, 500 μl of decontaminated sample were centrifuged at 13,000 rpm for 15 min; the pellet was then resuspended in 75 μl of sterile distilled water and processed as described for liquid cultures. The amplification was performed in a GeneAmp system 2400 (Perkin-Elmer) thermal cycler with a protocol consisting of 1 cycle at 95°C for 15 min (Taq activation cycle), followed by 10 cycles of denaturation at 95°C for 30 s and primer annealing at 58°C for 2 min, 30 cycles of denaturation at 95°C for 25 s, primer annealing at 53°C for 40 s, and extension at 70°C for 40 s, followed finally by extension at 70°C for 8 min.
Strain analysis.We applied the Genotype MTBDR assay to 206 M. tuberculosis strains isolated in Italy within the SMIRA prospective study for resistance monitoring in Italy (11, 23). Conventional susceptibility testing on all strains included in the present study was performed by the MGIT 9600 automated system and confirmed by a proportion method on Löwenstein-Jensen according to the World Health Organization's recommended protocol. Based on conventional susceptibility testing, 139 strains were classified as MDR, 30 strains were susceptible to the four first line drugs tested (RIF, INH, streptomycin [STR], and ethambutol [EMB]), and 37 were monoresistant or polyresistant but non-MDR.
Samples were sequenced for the regions of interest of rpoB and katG genes to compare the strip results with the nucleotide sequence. In addition, a small region of the promoter of the inhA gene was sequenced to detect the −15 C→T mutation in the mabAF-inhA operon, which was previously reported to be involved in INH and ethionamide resistance (13, 25).
Thirteen different MTBDR hybridization patterns corresponding to 17 aminoacidic substitutions in the rpoB hot-spot region were found. Figure 1 shows the positions of wild-type and mutated probes in the hot-spot region of rpoB. All of the mutations found in the hot-spot region of rpoB gene are reported in Fig. 2. In 103 strains the specific mutations could be identified directly by hybridization to the oligonucleotide targeting the mutated sequence, and in 30 strains they could be identified indirectly by the absence of specific wild-type signals (Table 2). Of the 142 RIF-resistant strains, 141 (99.3%) were recognized correctly by the MTBDR, with 91 showing a mutation in region 5, 20 showing a mutation in region 4, 4 showing a mutation in region 3, 10 showing a mutation in region 2, 3 showing a mutation in region 1, 2 showing a mutation in regions 1 and 2, 2 showing a mutation in regions 2 and 5, and 1 showing a mutation in regions 1, 2, and 4.
Mutations found in the rpoB “hot-spot region” of 142 M. tuberculosis strains. The arrowheads indicate the numbers and positions of omitted codons.
As expected, the test recognized as wild type a strain that had a duplication at codon 514 (15, 16). In six cases the test was able to identify correctly the mutation in a subregion within hot-spot region but did not classify the amino acid substitution despite the presence of a specific probe targeting that mutation (three cases for H526D, one case for H526Y, and two cases for S531L).
Codon 531 was the most frequently affected, being mutated in 90 of the 142 RIF-resistant strains (63.3%) included in the study, with 87 strains showing the specific nucleotide exchange of TCG to TTG, resulting in the amino acid substitution of serine to leucine (one strain showing a concomitant mutation at codon 516). Five strains had mutations located in codons 531 to 533, but the test was not able to identify the amino acid substitution. Codon 526 was affected in 20 cases (14.1%), with the test able to identify the specific mutation (H526Y) in 9 cases; codon 516 was affected in 13 strains (9.2%). Two strains presented hybridization patterns showing mutation, together with the wild-type pattern for the same codon, suggesting the simultaneous presence of wild-type and mutated DNA sequences. In these strains the presence of wild-type and mutated sequences was confirmed by sequencing analysis.
Eight strains phenotypically resistant to RIF were classified as susceptible by the test due to the presence of a hybridization pattern typical of the wild-type sequences in the hot-spot region. These strains were confirmed as wild type for the hot-spot region by sequencing. Sequencing of the upstream 268-bp region (positions 361 to 628), where additional mutations have been reported in literature (2), identified a valine-to-phenylalanine mutation at codon 170 in three of these strains.
A total of 61 of the 64 strains phenotypically RIF susceptible were recognized correctly. Three strains phenotypically RIF susceptible were identified as resistant by the presence of mutation in codon 533 (two cases) and by mutations in codons 511 and 516 (one case). In all three cases the mutations were confirmed by sequencing.
Analysis of INH resistance (Table 3) showed that the serine-to-threonine mutation at codon 315 was found in 115 strains (66.5%) of the 173 INH-R by susceptibility testing but in none of the 33 susceptible strains. A total of 112 strains showed the mutation AGC→ACC; only in one case did we find the mutation AGC→ACA. In one strain mutation in codon 315 was indicated by the absence of the wild-type hybridization signal only; sequencing demonstrated that the mutation was S315N (not targeted by a probe on the strip). Interestingly, the katG codon 315 mutation was observed at a much higher frequency in MDR isolates (67.6%) than in INH-monoresistant isolates (37.5%). Two strains presented hybridization patterns showing mutation together with the wild type, indicating the presence both wild-type and mutated DNA sequences. Fifty-six strains (32.4%) phenotypically INH-R were recognized as wild type at codon 315, as confirmed by sequencing. In one resistant case it was not possible to obtain any hybridization pattern for the INH probes despite a readable pattern for the RIF probes. Sequencing of this strain showed an extensive number of mutations in the examined region.
Mutations in the mabAF-inhA operon have been previously associated with INH resistance (13). Our investigation on the promoter region of the mabAF-inhA operon of the INH-resistant strains showing a wild-type sequence on KatG revealed that one-third (20 of 56) of them are mutated in this region (−15 C→T mutation).
Clinical specimen analysis.Thirty-six respiratory specimens collected from patients with a high clinical suspicion of active TB and positive for M. tuberculosis DNA as determined by MTD were evaluated for the presence of RIF- and INH-resistant M. tuberculosis by using the Genotype MTBDR kit.
The MTBDR assay simultaneously detected the presence of TB complex DNA and identified the presence of rpoB and/or katG gene mutations by hybridization with specific immobilized probes. The data obtained with the MTBDR assay were compared to “in vitro” susceptibility testing performed on the corresponding TB-positive cultures, and the results are reported in Table 4. All samples showed hybridization with the specific TB complex probe, confirming the MTD results; 29 of 36 samples showed no presence of mutation, whereas 2 showed a hybridization pattern suggestive of RIF resistance, one of them associated with the S315T katG mutation. Cultures from the two samples confirmed the presence of MDR strains. The presence of the S315T katG mutations was observed in an additional six cases; in four cases we observed a line probe profile consistent with a mixed infection with a sensitive and a resistant strain. Culture of the samples and sensitivity test performed on multiple colonies of the strain confirmed in this case the presence of an INH-resistant population together with a sensitive one.
The sensitivity and specificity of the test for detecting INH- and/or RIF-resistant strains from culture and clinical specimens are reported in Table 5.
We sought here to evaluate the potential contribution of a new test, Genotype MTBDR, to the timely laboratory detection of RIF- and INH-resistant strains, in particular when MDR disease is suspected.
RIF and INH are crucial drugs in tuberculosis treatment. RIF resistance is rarely observed as monoresistance and for this reason it is often considered a marker for MDR isolates. Published studies underline the relevance of molecular analysis indicating that isolates harboring mutations in codons 526 and 531 show both high-level resistance to RIF and cross-resistance between rifabutin and RIF (31, 40, 41 ). INH is the drug used for treatment of latent TB infection in close contacts of infectious cases. For these reasons it is critical for the clinician to know as soon as possible the susceptibility to these two key drugs. Several genotypic assays for resistance detection have been developed in the past few years (7, 10, 22, 27, 30, 34). Most of them requires equipment and skilled human resources that are not always available to routine clinical mycobacteriology laboratories.
The LiPA Rif-TB (Innogenetics, Ghent, Belgium) assay, a molecular method based on the reverse hybridization principle, became commercially available a few years ago. The test identifies strains as members of the M. tuberculosis complex, but it is restricted to the evaluation of the presence of mutations conferring RIF resistance.
The Genotype MTBDR test allows rapid and specific detection of most mutations conferring resistance not only to RIF but also to INH in M. tuberculosis isolates. This test combines the probes targeting the 81-bp “hot-spot” region in the rpoB gene, with two probes targeting two different mutations at position 315 of the katG gene. Mutations affecting this codon are responsible for INH resistance in ca. 60% of the cases worldwide (1, 20). The simultaneous detection of resistance to both RIF and INH allows an early diagnosis of an MDR case. Previous reports (5-7, 17, 21, 28) suggested that the frequency of particular mutations and the correlation of RIF resistance to the MDR phenotype could be different in selected populations.
As reported in Table 5, our results indicate that 99.3% (141 of 142) of the RIF-resistant strains investigated were correctly identified as RIF resistant by the test, and in 72.5% of the cases the mutation was identified by specific hybridization with a mutated probe. The MTBDR test was able to easily identify the presence of mutations in positions 526 and 531 and could be used as a predictor of MDR in 110 cases.
As expected, the S531L mutation was the most frequently observed in Italian MDR strains and was demonstrated in 84 cases (60.4%), followed by the H526Y in 9 cases (6.5%). A high frequency of the S531L mutation has also been reported in studies performed in other countries (9, 14, 20, 38).
A mutated codon 315 in katG was responsible for INH resistance in 67.1% (116 of 173) of the resistant strains included in the study, and all 116 strains were correctly detected by the LiPA assay.
Regarding the 139 MDR strains, the rpoB and katG probes selected in the test proved to be a sufficient tool to detect the relevant mutations conferring resistance to both RIF and INH of 97 of 139 of the cases, with a sensitivity of 69.8%. If we consider RIF resistance alone an accurate marker for MDR, the sensitivity of the test in MDR detection increases to 95.0%, with a specificity of 99.3%. The only false-negative case on the rpoB hot-spot region was due to the duplication of codon 514.
In three cases the MTBDR test was able to identify three additional MDR strains compared to the conventional susceptibility test. In all three cases the strains were collected from foreign-born, previously treated patients with known resistance to INH in one case and to INH, pyrazinamide (PZA), and STR in the other two. It is important to underline the capability of the MTBDR test to identify mutations conferring resistance to RIF in strains with a low level of resistance. As reported by Srivastava et al. (34), specific mutations in rpoB could be associated with low-level RIF resistance not detectable by a routine sensitivity test performed on Löwenstein-Jensen with a RIF concentration of 40 μg/ml. Importantly, a progression to a full MDR phenotype was observed from the same patients by sensitivity testing of serially collected isolates.
The main limitation of the test is low overall sensitivity for INH resistance. In fact, we were able to identify INH resistance only in 67% of the INH-resistant strains due to the fact that the test targets only the katG mutation at position 315. The addition of primers and probe targeting the −15 C→T mabAF-inhA mutation will substantially increase the number of INH resistant strains identified by the test. This mutation is also linked to ethionamide resistance (25). An additional limitation that needs to be considered is the predicted detection limit of 5 to 10% mutant/wild-type ratio. The MTBDR is a reliable test when used on clinical isolates, but culture growth requires 2 to 4 weeks, and sensitivity results are not available at the beginning of therapy (15). Performing the test on selected clinical specimens may give critical information needed for appropriate treatment in a very short time and can be crucial for avoiding the transmission of drug-resistant M. tuberculosis strains. Indeed, the results are available in the same day. Considering the RIF resistance, the MTBDR profiles obtained from clinical samples were consistent with the results of sensitivity testing performed on the strains obtained from their culture. For both resistant and sensitive strains the concordance rate was 100%. For INH, we had a mixed pattern of sensitive and resistant population in six samples. The sensitivity test results for INH indicated resistance in five cases and sensitivity in one case.
The results of our study demonstrate that the rate of concordance of the Genotype MTBDR findings with those of traditional methods and sequencing data is high. For this reason this test can be successfully applied in a clinical laboratory setting when a rapid sensitivity testing is required for the correct management of patients or the contacts of resistant cases. However, because only some of the mutations are targeted, this molecular test cannot be considered, at the present time, as a full alternative to conventional susceptibility testing for RIF and INH, and the results obtained by molecular methods must be confirmed by phenotypic tests.
Due to the high prevalence of MDR cases in some areas in Europe and to the high numbers of immigrants from these regions, the additional cost of the test could be justified in all new cases or retreatments in which MDR-TB is suspected, and the results of the screening could allow appropriate management of the patients.
This study was partially supported by Italian grant RF04/126 to D.M.C.
We thank P. Cavallerio, M. Sampaolo, and M. A. Grasso for technical assistance; E. Boeri for helpful discussions of the data; and Arnika s.r.l., Milan, Italy, for providing the automated instruments for the Genotype MTBDR assay.
Returned for modification 27 March 2006.
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matches: v. V. V. V. V. V. V. V. V.


The purpose of this section is to authorize a demonstration mortgage risk-sharing program designed to test the feasibility of entering into risk-sharing contracts with private mortgage insurers and with insured community development financial institutions in order to reduce Government risk and administrative costs, and to speed mortgage processing. The Secretary shall limit the demonstration under this section to not more than four administrative regions of the Department of Housing and Urban Development, and shall assure that the program is in the financial interest of the Government and will not result in loss of employment by any employees of the Department of Housing and Urban Development before the expiration of the 5-year period beginning on December 21, 2000. The aggregate number of mortgages for which risk of nonpayment is shared under this section in any administrative region of the Department of Housing and Urban Development in any fiscal year may not exceed 20 percent of the aggregate number of mortgages and loans insured by the Secretary under this subchapter in such region during the preceding fiscal year.
(2) perform or delegate underwriting, credit approval, appraisal, inspection, commitment, claims processing, property disposition, or other functions as the Secretary shall approve as consistent with the purposes of this section and shall set forth in the risk-sharing contract.
Any contract for risk-sharing under this section shall contain such provisions relating to the sharing of premiums received by the Secretary with a private mortgage insurer or insured community development financial institution on a sound actuarial basis, establishment of loss reserves, manner of calculating claims on such risk-sharing contract, conditions with respect to foreclosure, handling and disposition of property prior to claim or settlement, rights of assignees, and other similar matters as the Secretary may prescribe pursuant to regulations. Pursuant to a contract under this section, a private mortgage insurance company or insured community development financial institution shall endorse loans for risk-sharing and take such other actions on behalf of the Secretary and in the Secretary's name as the Secretary may authorize.
The Secretary shall require any private mortgage insurance company or insured community development financial institution participating in the program under this section to provide risk-sharing for those mortgages offered by the Secretary for inclusion in the program.
For purposes of this section, the term "insured community development financial institution" means a community development financial institution, as such term is defined in section 4702 of this title that is an insured depository institution (as such term is defined in section 1813 of this title) or an insured credit union (as such term is defined in section 1752 of this title).
Section 1715z–10 of this title, referred to in subsec. (b), was repealed by Pub. L. 110–289, div. B, title I, §2120(a)(7), July 30, 2008, 122 Stat. 2835 .
2000-Pub. L. 106–554, §1(a)(7) [title I, §143(1)], substituted "Risk-sharing demonstration" for "Reinsurance contracts" in section catchline.
Subsec. (a). Pub. L. 106–554, §1(a)(7) [title I, §143(2), (3)], in heading and first sentence substituted "risk-sharing" for "reinsurance" wherever appearing, in first sentence inserted "and with insured community development financial institutions" after "private mortgage insurers", in second sentence substituted "four administrative regions" for "two administrative regions" and "the expiration of the 5-year period beginning on December 21, 2000" for "March 15, 1988", and in last sentence substituted "mortgages for which risk of nonpayment is shared" for "mortgages insured" and "20 percent" for "10 percent".
Subsec. (b). Pub. L. 106–554, §1(a)(7) [title I, §143(2), (4)(A), (B)], in first sentence of introductory provisions, substituted ", in providing" for "to provide", ", to enter into" for "through" and "risk-sharing" for "reinsurance" and inserted "and with insured community development financial institutions" before period at end and, in second sentence of introductory provisions, inserted "and insured community development financial institutions" after "private mortgage insurance companies".
Subsec. (b)(1). Pub. L. 106–554, §1(a)(7) [title I, §143(4)(C)], added par. (1) and struck out former par. (1) which read as follows: "assume a percentage of loss on any mortgage insured pursuant to section 1709(b), 1715y, or 1715z–10 of this title covering a one- to four-family dwelling, which percentage of loss shall be set forth in the risk-sharing contract; and".
Pub. L. 106–554, §1(a)(7) [title I, §143(2)], substituted "risk-sharing" for "reinsurance".
Subsec. (b)(2). Pub. L. 106–554, §1(a)(7) [title I, §143(4)(D)], substituted "perform or delegate underwriting," for "carry out (under appropriate delegation) such" and "functions as the Secretary" for "function as the Secretary pursuant to regulations," and inserted before period at end "and shall set forth in the risk-sharing contract".
Subsec. (c). Pub. L. 106–554, §1(a)(7) [title I, §143(2), (5)], in first sentence, substituted "contract for" for "contract of" and "risk-sharing" for "reinsurance", inserted "received by the Secretary with a private mortgage insurer or insured community development financial institution" after "sharing of premiums", substituted "loss reserves" for "insurance reserves", "such risk-sharing contract" for "such insurance", and "rights of assignees" for "right of assignees" and, in second sentence, inserted "or insured community development financial institution" after "private mortgage insurance company" and substituted "loans for risk-sharing" for "loans for insurance".
Subsec. (d). Pub. L. 106–554, §1(a)(7) [title I, §143(2), (6)], inserted "or insured community development financial institution" after "private mortgage insurance company" and substituted "risk-sharing" for "reinsurance".
Subsec. (e). Pub. L. 106–554, §1(a)(7) [title I, §143(7)], added subsec. (e).
1985-Subsec. (a). Pub. L. 99–219 substituted "March 17, 1986" for "December 15, 1985".
Pub. L. 99–156 substituted "December 15, 1985" for "November 14, 1985".
Pub. L. 99–120 substituted "November 14, 1985" for "September 30, 1985".
Pub. L. 98–181, title I [title IV, §428(b)], Nov. 30, 1983, 97 Stat. 1219 , provided that: "The Secretary of Housing and Urban Development shall evaluate the reinsurance program under section 249 of the National Housing Act [this section] and, not later than March 1, 1985, submit to the Congress a report setting forth the results of such evaluation. Such report shall include an evaluation of the possible effect of a reinsurance program on the characteristics of the pool of mortgages remaining wholly under the applicable insurance funds and the actuarial soundness of such funds under such conditions."
2 So in original. Probably should be followed by "and".


The Secretary, in cooperation with representatives of agencies and organizations involved in student financial assistance, shall produce, distribute, and process free of charge common financial reporting forms as described in this subsection to be used for application and reapplication to determine the need and eligibility of a student for financial assistance under parts A through E (other than under subpart 4 of part A). The forms shall be made available to applicants in both paper and electronic formats and shall be referred to as the "Free Application for Federal Student Aid" or the "FAFSA". The Secretary shall work to make the FAFSA consumer-friendly and to make questions on the FAFSA easy for students and families to read and understand, and shall ensure that the FAFSA is available in formats accessible to individuals with disabilities.
(ii) a paper version of the other forms described in this subsection, in accordance with subparagraph (C), for any applicant who does not meet the requirements of or does not wish to use the process described in subparagraph (B).
The Secretary shall develop and use, after appropriate field testing, a simplified paper form, to be known as the EZ FAFSA, to be used for applicants meeting the requirements of subsection (b) or (c) of section 1087ss of this title.
The EZ FAFSA shall permit an applicant to submit, for financial assistance purposes, only the data elements required to make a determination of whether the applicant meets the requirements under subsection (b) or (c) of section 1087ss of this title.
The Secretary shall include on the EZ FAFSA such data items as may be necessary to award State financial assistance, as provided under paragraph (5), except that the Secretary shall not include a State's data if that State does not permit the State's resident applicants to use the EZ FAFSA for State assistance.
The provisions of paragraph (6) shall apply to the EZ FAFSA, and the data collected by means of the EZ FAFSA shall be available to institutions of higher education, guaranty agencies, and States in accordance with paragraph (10).
The Secretary shall make all efforts to encourage all applicants to utilize the electronic version of the forms described in paragraph (3).
The Secretary shall maintain a version of the paper forms described in subparagraphs (A) and (B) in a printable electronic file that is easily portable, accessible, and downloadable to students on the same website used to provide students with the electronic version of the forms described in paragraph (3).
The Secretary shall provide a printed copy of the full paper version of FAFSA upon request.
The Secretary shall produce, distribute, and process forms in electronic format to meet the requirements of paragraph (1). The Secretary shall develop an electronic version of the forms for applicants who do not meet the requirements of subsection (b) or (c) of section 1087ss of this title.
The Secretary shall develop and use a simplified electronic version of the form to be used by applicants meeting the requirements under subsection (b) or (c) of section 1087ss of this title.
The simplified electronic version of the forms shall permit an applicant to submit, for financial assistance purposes, only the data elements required to make a determination of whether the applicant meets the requirements under subsection (b) or (c) of section 1087ss of this title.
Nothing in this subsection shall be construed to prohibit the use of the forms developed by the Secretary pursuant to this paragraph by an eligible institution, eligible lender, guaranty agency, State grant agency, private computer software provider, a consortium thereof, or such other entities as the Secretary may designate.
The Secretary shall include on the electronic version of the forms such items as may be necessary to determine eligibility for State financial assistance, as provided under paragraph (5), except that the Secretary shall not require an applicant to enter data pursuant to this subparagraph that are required by any State other than the applicant's State of residence.
The data collected by means of the simplified electronic version of the forms shall be available to institutions of higher education, guaranty agencies, and States in accordance with paragraph (10).
The Secretary shall ensure that data collection under this paragraph complies with section 552a of title 5 and that any entity using the electronic version of the forms developed by the Secretary pursuant to this paragraph shall maintain reasonable and appropriate administrative, technical, and physical safeguards to ensure the integrity and confidentiality of the information, and to protect against security threats, or unauthorized uses or disclosures of the information provided on the electronic version of the forms. Data collected by such electronic version of the forms shall be used only for the application, award, and administration of aid awarded under this subchapter, State aid, or aid awarded by eligible institutions or such entities as the Secretary may designate. No data collected by such electronic version of the forms shall be used for making final aid awards under this subchapter until such data have been processed by the Secretary or a contractor or designee of the Secretary, except as may be permitted under this subchapter.
Notwithstanding any other provision of this chapter, the Secretary may continue to permit an electronic version of the form under this paragraph to be submitted without a signature, if a signature is subsequently submitted by the applicant or if the applicant uses a personal identification number provided by the Secretary under subparagraph (G).
(ii) for any purpose determined by the Secretary to enable the Secretary to carry out this subchapter.
The Secretary shall continue to work with the Commissioner of Social Security to minimize the time required for an applicant to obtain a personal identification number when applying for aid under this subchapter through an electronic version of a form developed under this paragraph.
The Secretary shall continue to streamline reapplication forms and processes for an applicant who applies for financial assistance under this subchapter in the next succeeding academic year subsequent to an academic year for which such applicant applied for financial assistance under this subchapter.
The Secretary shall determine, in cooperation with States, institutions of higher education, agencies, and organizations involved in student financial assistance, the data elements that may be transferred from the previous academic year's application and those data elements that shall be updated.
Nothing in this subchapter shall be construed as limiting the authority of the Secretary to reduce the number of data elements required of reapplicants.
Applicants determined to have a zero family contribution pursuant to section 1087ss(c) of this title shall not be required to provide any financial data in a reapplication form, except data that are necessary to determine eligibility under such section.
Of the number of data elements on the FAFSA used for the 2009–2010 award year, the Secretary, in cooperation with representatives of agencies and organizations involved in student financial assistance and consistent with efforts under subsection (c), shall continue to reduce the number of such data elements required to be entered by all applicants, with the goal of reducing such number by 50 percent.
The Secretary shall submit a report on the process of this reduction to each of the authorizing committees by June 30, 2011.
Except as provided in paragraphs (2)(B)(iii), (3)(B), and (4)(A)(ii), the Secretary shall include on the forms developed under this subsection, such State-specific data items as the Secretary determines are necessary to meet State requirements for need-based State aid. Such items shall be selected in consultation with State agencies in order to assist in the awarding of State financial assistance in accordance with the terms of this subsection. The number of such data items shall not be less than the number included on the form for the 2008–2009 award year unless a State notifies the Secretary that the State no longer requires those data items for the distribution of State need-based aid.
(ii) if the State will permit an applicant to file a form described in paragraph (2)(B) or (3)(B).
(ii) of the State-specific nonfinancial data that the State agency requires for delivery of State need-based financial aid.
The Secretary shall encourage States to take such steps as are necessary to encourage the use of simplified forms under this subsection, including those forms described in paragraphs (2)(B) and (3)(B), for applicants who meet the requirements of subsection (b) or (c) of section 1087ss of this title.
If a State does not permit an applicant to file a form described in paragraph (2)(B) or (3)(B) for purposes of determining eligibility for State need-based financial aid, the Secretary may determine that State-specific questions for such State will not be included on a form described in paragraph (2)(B) or (3)(B). If the Secretary makes such determination, the Secretary shall advise the State of the Secretary's determination.
(ii) not require any resident of such State to complete any data items previously required by that State under this section.
The need and eligibility of a student for financial assistance under parts A through E (other than under subpart 4 of part A) may be determined only by using a form developed by the Secretary under this subsection. Such forms shall be produced, distributed, and processed by the Secretary, and no parent or student shall be charged a fee by the Secretary, a contractor, a third-party servicer or private software provider, or any other public or private entity for the collection, processing, or delivery of financial aid through the use of such forms. No data collected on a form for which a fee is charged shall be used to complete the form prescribed under this section, except that a Federal or State income tax form prepared by a paid income tax preparer or preparer service for the primary purpose of filing a Federal or State income tax return may be used to complete the form prescribed under this section.
No person, commercial entity, or other entity may request, obtain, or utilize an applicant's personal identification number assigned under paragraph (3)(G) for purposes of submitting a form developed under this subsection on an applicant's behalf.
The Secretary shall enable students to submit forms developed under this subsection and initiate the processing of such forms under this subsection, as early as practicable prior to January 1 of the student's planned year of enrollment.
(E) consult with representatives of States, institutions of higher education, and other individuals with experience or expertise in student financial assistance application processes in making updates to forms used to provide early estimates under this paragraph.
Institutions of higher education, guaranty agencies, and States shall receive, without charge, the data collected by the Secretary using a form developed under this subsection for the purposes of processing loan applications and determining need and eligibility for institutional and State financial aid awards. Entities designated by institutions of higher education, guaranty agencies, or States to receive such data shall be subject to all the requirements of this section, unless such requirements are waived by the Secretary.
To the extent practicable and in a timely manner, the Secretary shall provide, to private organizations and consortia that develop software used by institutions of higher education for the administration of funds under this subchapter, all the necessary specifications that the organizations and consortia must meet for the software the organizations and consortia develop, produce, and distribute (including any diskette, modem, or network communications) to be so used. The specifications shall contain record layouts for required data. The Secretary shall develop in advance of each processing cycle an annual schedule for providing such specifications. The Secretary, to the extent practicable, shall use multiple means of providing such specifications, including conferences and other meetings, outreach, and technical support mechanisms (such as training and printed reference materials). The Secretary shall, from time to time, solicit from such organizations and consortia means of improving the support provided by the Secretary.
The Secretary is authorized to include space on the forms developed under this subsection for the social security number and birth date of parents of dependent students seeking financial assistance under this subchapter.
Copies of all rules, regulations, guidelines, instructions, and application forms published or promulgated pursuant to this subchapter shall be provided to the authorizing committees at least 45 days prior to their effective date.
The Secretary shall contract for, or establish, and publicize a toll-free telephone service to provide timely and accurate information to the general public. The information provided shall include specific instructions on completing the application form for assistance under this subchapter. Such service shall also include a service accessible by telecommunications devices for the deaf (TDD's) and shall, in addition to the services provided for in the previous sentence, refer such students to the national clearinghouse on postsecondary education or other appropriate provider of technical assistance and information on postsecondary educational services for individuals with disabilities, including the National Technical Assistance Center under section 1140q of this title. The Secretary shall continue to implement, to the extent practicable, a toll-free telephone based system to permit applicants who meet the requirements of subsection (b) or (c) of section 1087ss of this title to submit an application over such system.
Notwithstanding any provision of this chapter, an applicant may use a preparer for consultative or preparation services for the completion of a form developed under subsection (a) if the preparer satisfies the requirements of this subsection.
(B) be subject to the same penalties as an applicant for purposely giving false or misleading information in the application.
(D) not produce, use, or disseminate any other form for the purpose of applying for Federal student financial aid other than the form developed by the Secretary under subsection (a).
Nothing in this chapter shall be construed to limit preparers of the forms required under this subchapter that meet the requirements of this subsection from collecting source information from a student or parent, including Internal Revenue Service tax forms, in providing consultative and preparation services in completing the forms.
(A) To measure the feasibility of enabling dependent students to apply for Federal, State, and institutional financial aid in their junior year of secondary school, using information from two years prior to the year of enrollment, by completing any of the forms under this subsection.
(B) To identify whether receiving final financial aid award estimates not later than the fall of the senior year of secondary school provides students with additional time to compete for the limited resources available for State and institutional financial aid and positively impacts the college aspirations and plans of these students.
(ii) the cost of financial aid programs under this subchapter.
(D) To effectively evaluate the benefits and adverse effects of the demonstration program on program costs, integrity, distribution, and delivery of financial aid.
(B) based on the application described in subparagraph (A), to obtain, not later than one year prior to the year of the students' planned enrollment, information on eligibility for Federal Pell Grants, Federal student loans under this subchapter, and State and institutional financial aid for the student's first year of enrollment in the institution of higher education.
(B) remind the students of the need to update the students' information during the calendar year of enrollment using the expedited reapplication process provided for in subsection (a)(4)(A).
(iv) participating in the evaluation of the program.
(F) such other information as the Secretary may require.
A financial aid administrator at an institution of higher education participating in a demonstration program under this subsection may use the discretion provided under section 1087tt of this title as necessary for students participating in the demonstration program.
The Secretary is authorized to waive, for an institution of higher education participating in the demonstration program, any requirements under this subchapter, or regulations prescribed under this subchapter, that will make the demonstration program unworkable, except that the Secretary shall not waive any provisions with respect to the maximum award amounts for grants and loans under this subchapter.
The Secretary shall make appropriate efforts to notify States of the demonstration program under this subsection. Upon determination of participating States, the Secretary shall continue to make efforts to notify institutions of higher education and dependent students within participating States of the opportunity to participate in the demonstration program and of the participation requirements.
(F) examine the extent to which estimated awards differ from actual awards made to students participating in the program.
The Secretary shall consult, as appropriate, with the Advisory Committee on Student Financial Assistance established under section 1098 of this title on the design, implementation, and evaluation of the demonstration program.
(C) whether the data elements collected on the FAFSA that are needed to determine eligibility for student aid, or to administer the Federal student financial aid programs under this subchapter, but are not needed to compute an expected family contribution, such as information regarding the student's citizenship or permanent residency status, registration for selective service, or driver's license number, can be reduced without adverse effects.
(G) the extent to which the data elements collected on the FAFSA on March 31, 2008, that are needed to determine eligibility for student aid or to administer the Federal student financial aid programs, but are not needed to compute an expected family contribution, such as information regarding the student's citizenship or permanent residency status, registration for selective service, or driver's license number, can be reduced without adverse effects.
Not later than 90 days after August 14, 2008, the Comptroller General shall convene a study group the membership of which shall include the Secretary of Education, the Secretary of the Treasury, the Director of the Office of Management and Budget, the Director of the Congressional Budget Office, representatives of institutions of higher education with expertise in Federal and State financial aid assistance, State chief executive officers of higher education with a demonstrated commitment to simplifying the FAFSA, and such other individuals as the Comptroller General and the Secretary of Education may designate.
(iii) make recommendations to the authorizing committees.
(iii) to review State and institutional needs and uses for data collected on the FAFSA, and to determine the best means of addressing such needs in the case of modification of the FAFSA as described in clause (i), or modification of the need analysis formula as described in clause (ii).
(V) changes to this chapter or other laws that will be required to implement a modified need analysis system.
The Secretary shall consult with the Advisory Committee on Student Financial Assistance established under section 1098 of this title as appropriate in carrying out this subsection.
(ii) not later than two years after August 14, 2008, a final report on the results of the study required under paragraph (3) that includes recommendations by the study group established under such paragraph.
The Secretary shall report to the authorizing committees, from time to time, on the progress of the simplification efforts under this subsection.
The Secretary shall utilize savings accrued by moving more applicants to the electronic version of the forms described in subsection (a)(3) to improve access to the electronic version of the forms described in such subsection for applicants meeting the requirements of subsection (b) or (c) of section 1087ss of this title.
(2) additional information regarding the steps a student or family member may take in order to seek an adjustment under section 1087tt of this title.
A prior section 1090, Pub. L. 89–329, title IV, §483, as added Pub. L. 96–374, title IV, §451(a), Oct. 3, 1980, 94 Stat. 1448 , related to forms and regulations for student assistance programs, prior to the general revision of this part by Pub. L. 99–498.
2010-Subsec. (e)(3)(A)(ii). Pub. L. 111–152 substituted "based on the Federal Pell Grant amount, determined under section 1070a(b)(2)(A) of this title, for which a student is eligible at the time of application" for "based on the maximum Federal Pell Grant award at the time of application".
2009-Subsec. (a)(3)(C). Pub. L. 111–39, §407(b)(3)(A), inserted "that" after "except".
Subsec. (e)(8)(A). Pub. L. 111–39, §407(b)(3)(B), substituted "determine" for "identify".
2008-Subsec. (a). Pub. L. 110–315, §483(a)(1), added pars. (1) to (12) and struck out former pars. (1) to (7), which related to forms required, charges for forms, distribution of data, contracts for collection and processing, electronic forms, third party servicers and private software providers, and parents' social security numbers and birth dates.
Subsec. (b). Pub. L. 110–315, §483(a)(2), (3), redesignated subsec. (c) as (b) and struck out former subsec. (b) which related to streamlined reapplication process.
Subsec. (c). Pub. L. 110–315, §483(a)(4), substituted "or other appropriate provider of technical assistance and information on postsecondary educational services for individuals with disabilities, including the National Technical Assistance Center under section 1140q of this title. The Secretary shall continue to implement, to the extent practicable, a toll-free telephone based system to permit applicants who meet the requirements of subsection (b) or (c) of section 1087ss of this title to submit an application over such system" for "that is authorized under section 1485(d)(2)(C) of this title".
Pub. L. 110–315, §483(a)(3), redesignated subsec. (d) as (c). Former subsec. (c) redesignated (b).
Pub. L. 110–315, §103(b)(10), substituted "authorizing committees" for "Committee on Labor and Human Resources of the Senate and the Committee on Education and the Workforce of the House of Representatives".
Subsec. (d). Pub. L. 110–315, §483(a)(5), added subsec. (d). Former subsec. (d) redesignated (c).
Subsec. (e). Pub. L. 110–315, §483(a)(2), (5), added subsec. (e) and struck out former subsec. (e). Prior to amendment, text read as follows: "Any financial aid application required to be made under this subchapter shall include the name, signature, address or employer's address, social security number or employer identification number, and organizational affiliation of the preparer of such financial aid application."
Subsecs. (f) to (h). Pub. L. 110–315, §483(a)(5), added subsecs. (f) to (h).
1998-Subsec. (a). Pub. L. 105–244, §482(a)(1), substituted "form development" for "form" in heading.
Subsec. (a)(1). Pub. L. 105–244, §482(a)(2)(D), struck out at end "For the purpose of collecting eligibility and other data for the purpose of part B of this subchapter, the Secretary shall develop a separate, identifiable loan application document (pursuant to section 1082(m) of this title) that applicants or institutions in which the students are enrolled or accepted for enrollment shall submit directly to eligible lenders and on which the applicant shall clearly indicate a choice of a lender."
Pub. L. 105–244, §482(a)(2)(C), substituted "The Secretary shall include on the form developed under this subsection such data items as the Secretary determines are appropriate for inclusion. Such items shall be selected in consultation with States to assist in the awarding of State financial assistance. In no case shall the number of such data items be less than the number included on the form on October 7, 1998." for "The Secretary may include on the form developed pursuant to this paragraph not more than eight nonfinancial data items selected in consultation with the States to assist the States in awarding State student financial assistance."
Pub. L. 105–244, §482(a)(2)(A), (B), substituted "A through D" for "A, C, and D" and struck out "and to determine the need of a student for the purpose of part B of this subchapter" after "part A of this subchapter)".
Subsec. (a)(2). Pub. L. 105–244, §482(a)(3), substituted "A through D" for "A, C, and D" in two places and struck out "and the need of a student for the purpose of part B of this subchapter," before "may only be determined" and "or have the student's need established for the purpose of part B of this subchapter" before ", except by use of".
Subsec. (a)(3). Pub. L. 105–244, §482(a)(4), amended heading and text of par. (3) generally. Prior to amendment, text read as follows: "Institutions of higher education and States shall receive, without charge, the data collected by the Secretary using the form developed pursuant to this section for the purposes of determining need and eligibility for institutional and State financial aid awards. Entities designated by institutions of higher education or States to receive such data shall be subject to all requirements of this section, unless such requirements are waived by the Secretary."
Subsec. (a)(5) to (7). Pub. L. 105–244, §482(a)(5), added pars. (5) to (7).
Subsec. (b)(1). Pub. L. 105–244, §482(b), struck out ", within 240 days after July 23, 1992," after "The Secretary shall".
Subsec. (c). Pub. L. 105–244, §482(c), substituted "and the Workforce" for "and Labor".
Subsec. (d). Pub. L. 105–244, §482(d), substituted "section 1485(d)(2)(C)" for "section 1433(c)".
Subsec. (f). Pub. L. 105–244, §482(e), struck out heading and text of subsec. (f). Text read as follows: "Nothing in section 1544 of the Higher Education Amendments of 1992 shall relieve processors or institutions of higher education of any or all obligations under this section."
1993-Subsec. (a)(1). Pub. L. 103–208, §2(h)(8), made technical amendment to reference to section 1070a(d) of this title to correct reference to corresponding section of original act.
Subsec. (a)(2). Pub. L. 103–208, §2(h)(9), inserted at end "No data collected on a form for which a fee is charged shall be used to complete the form prescribed under paragraph (1)."
Subsec. (a)(3). Pub. L. 103–208, §2(h)(10), inserted at end "Entities designated by institutions of higher education or States to receive such data shall be subject to all requirements of this section, unless such requirements are waived by the Secretary."
Subsecs. (d), (e). Pub. L. 103–208, §2(h)(12), redesignated subsecs. (e) and (f) as (d) and (e), respectively.
Subsec. (f). Pub. L. 103–208, §2(h)(12), redesignated subsec. (g) as (f). Former subsec. (f) redesignated (e).
Pub. L. 103–208, §2(h)(11), substituted "address or employer's address, social security number or employer identification number," for "address, social security number,".
Subsec. (g). Pub. L. 103–208, §2(h)(12), redesignated subsec. (g) as (f).
1992-Subsec. (a). Pub. L. 102–325, §483(a), added subsec. (a) and struck out former subsec. (a) which contained pars. (1) to (5) relating to a common financial aid form and processing of financial aid applications.
Subsec. (b). Pub. L. 102–325, §483(a), added subsec. (b) and struck out former subsec. (b) which related to certifications of capability of systems for determining expected family contributions.
Subsec. (d). Pub. L. 102–325, §483(b)(1), struck out subsec. (d) which related to provision of early notice to students of their potential eligibility for financial aid.
Subsec. (e). Pub. L. 102–325, §483(b)(2), amended subsec. (e) generally. Prior to amendment, subsec. (e) read as follows: "The Secretary shall contract for, or establish, and publicize a toll-free telephone number to provide timely and accurate information to the general public. The information provided shall include specific instructions on completing application forms for assistance under this subchapter."
Subsecs. (f), (g). Pub. L. 102–325, §483(b)(1), (3), added subsecs. (f) and (g) and struck out former subsec. (f) which related to notice of student aid receipt.
1987-Subsec. (a)(1). Pub. L. 100–50, §15(3), (4), inserted in second sentence "or institutions in which the students are enrolled or accepted for enrollment" after "that applicants" and "and on which the applicant shall clearly indicate a choice of lender" before period at end.
Subsec. (a)(2). Pub. L. 100–50, §15(5), substituted "not less than 5" for "not less than 3" and inserted sentence at end providing that the Secretary not select new multiple data entry processors until certain examinations and recommendations are made by the Advisory Commission on Student Financial Assistance.
Subsecs. (b) to (f). Pub. L. 100–50, §15(6), added subsec. (b) and redesignated former subsecs. (b) to (e) as (c) to (f), respectively.
Subsec. (e) of this section applicable to student assistance awarded for periods of enrollment beginning on or after July 1, 1987, see section 407(b) of Pub. L. 99–498, set out as a note under section 1091 of this title.
"(2) utilize such identification as a tool to notify students who are foster youth or were in the foster care system of their potential eligibility for Federal student aid, including postsecondary education programs through the John H. Chafee Foster Care Independence Program and any other Federal programs under which such students may be eligible to receive assistance."
Pub. L. 113–76, div. H, title III, §310, Jan. 17, 2014, 128 Stat. 400 .
"(2) Subsection (h) of such section."