Notices. Notice and request for comment
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/register/2007/02/06/07-501A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
BILLING CODE 6705-01-P FEDERAL RESERVE SYSTEM Formations of, Acquisitions by, and Mergers of Bank Holding Companies The companies listed in this notice have applied to the Board for approval, pursuant to the Bank Holding Company Act of 1956 (12 U.S.C. 1841 *et seq.* ) (BHC Act), Regulation Y (12 CFR Part 225), and all other applicable statutes and regulations to become a bank holding company and/or to acquire the assets or the ownership of, control of, or the power to vote shares of a bank or bank holding company and all of the banks and nonbanking companies owned by the bank holding company, including the companies listed below.
The applications listed below, as well as other related filings required by the Board, are available for immediate inspection at the Federal Reserve Bank indicated. The application also will be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing on the standards enumerated in the BHC Act (12 U.S.C. 1842(c)). If the proposal also involves the acquisition of a nonbanking company, the review also includes whether the acquisition of the nonbanking company complies with the standards in section 4 of the BHC Act (12 U.S.C. 1843).
Unless otherwise noted, nonbanking activities will be conducted throughout the United States. Additional information on all bank holding companies may be obtained from the National Information Center Web site at *http://www.ffiec.gov/nic/* . Unless otherwise noted, comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors not later than March 5, 2007. **A. Federal Reserve Bank of Minneapolis** (Jacqueline G.
King, Community Affairs Officer) 90 Hennepin Avenue, Minneapolis, Minnesota 55480-0291: *1. Hayward Bancshares, Inc., Eau Claire, Wisconsin* to acquire 100 percent of the voting shares of Summit Community Bank, Maplewood, Minnesota. **B. Federal Reserve Bank of Kansas City** (Donna J. Ward, Assistant Vice President) 925 Grand Avenue, Kansas City, Missouri 64198-0001: *1. Kaw Valley Bancshares, Inc.,* to acquire 100 percent of the voting shares of Kaw Valley State Bank & Trust Company, both of Wamego, Kansas.
Board of Governors of the Federal Reserve System, February 1, 2007. Robert deV. Frierson, Deputy Secretary of the Board. [FR Doc. E7-1887 Filed 2-5-07; 8:45 am] BILLING CODE 6210-01-S FEDERAL TRADE COMMISSION Agency Information Collection Activities; Reinstatement of Existing Collection; Comment Request AGENCY: Federal Trade Commission. ACTION: Notice and request for comment. SUMMARY: The Federal Trade Commission (“FTC” or “Commission”) intends to conduct a pilot study in connection with Section 319 of the Fair and Accurate Credit Transactions Act of 2003.
This study is a follow-up to the Commission's previous pilot study conducted from October 2005 through June 2006. Before gathering this information, the FTC is seeking public comment on its proposed consumer pilot study. The information collection requirements described below will be submitted to the Office of Management and Budget (“OMB”) for review, as required by the Paperwork Reduction Act. DATES: Public comments must be received on or before March 8, 2007. ADDRESSES: Interested parties are invited to submit written comments.
Comments should refer to “Accuracy Pilot Study: Paperwork Comment (FTC file no. P044804)” to facilitate the organization of the comments. A comment filed in paper form should include this reference both in the text and on the envelope and should be mailed or delivered, with two complete copies, to the following address: Federal Trade Commission/Office of the Secretary, Room H-135 (Annex J), 600 Pennsylvania Avenue, NW., Washington, DC 20580. Because paper mail in the Washington area and at the Commission is subject to delay, please consider submitting your comments in electronic form, as prescribed below.
However, if the comment contains any material for which confidential treatment is requested, it must be filed in paper form, and the first page of the document must be clearly labeled “Confidential.” 1 The FTC is requesting that any comment filed in paper form be sent by courier or overnight service, if possible. 1 Commission Rule 4.2(d), 16 CFR 4.2(d). The comment must be accompanied by an explicit request for confidential treatment, including the factual and legal basis for the request, and must identify the specific portions of the comment to be withheld from the public record.
The request will be granted or denied by the Commission's General Counsel, consistent with applicable law and the public interest. *See* Commission Rule 4.9(c), 16 CFR 4.9(c). Comments filed in electronic form should be submitted by using the following Web link: *https://secure.commentworks.com/ftc-accuracy-expand* (and following the instructions on the Web-based form). To ensure that the Commission considers an electronic comment, you must file it on the Web-based form at the Web link *https://secure.commentworks.com/ftc-accuracy-expand.* If this notice appears at *www.regulations.gov* , you may also file an electronic comment through that Web site.
The Commission will consider all comments that regulations.gov forwards to it. Comments should also be submitted to: Office of Management and Budget, Attention: Desk Officer for the Federal Trade Commission. Comments should be submitted via facsimile to
(202)395-6974 because U.S. Postal Mail is subject to lengthy delays due to heightened security precautions. The FTC Act and other laws the Commission administers permit the collection of public comments to consider and use in this proceeding as appropriate. All timely and responsive public comments, whether filed in paper or electronic form, will be considered by the Commission, and will be available to the public on the FTC Web site, to the extent practicable, at *http://www.ftc.gov.* As a matter of discretion, the FTC makes every effort to remove home contact information for individuals from public comments it receives before placing those comments on the FTC Web site. More information, including routine uses permitted by the Privacy Act, may be found in the FTC's privacy policy, at *http://www.ftc.gov/ftc/privacy.htm.* FOR FURTHER INFORMATION CONTACT: Peter Vander Nat, Economist,
(202)326-3518, Federal Trade Commission, Bureau of Economics, 600 Pennsylvania Ave., NW., Washington, DC 20580. SUPPLEMENTARY INFORMATION: Section 319 of the Fair and Accurate Credit Transactions Act of 2003 (“FACT Act”), Pub. L. 108-159 (2003), requires the FTC to study the accuracy and completeness of information in consumers' credit reports and to consider methods for improving the accuracy and completeness of such information. Section 319 of the FACT Act requires the Commission to issue a series of biennial reports to Congress over a period of eleven years, and the FTC has submitted two reports thus far: one in December 2004 (“December 2004 Report”) and another in December 2006 (“December 2006 Report”). 2 2 Report to Congress Under Sections 318 and 319 of the Fair and Accurate Credit Transactions Act of 2003, Federal Trade Commission, December 2004, and Report to Congress Under Section 319 of the Fair and Accurate Credit Transactions Act of 2003, Federal Trade Commission, December 2006. The respective reports are available on the FTC's Web site at *http://www.ftc.gov/reports/index.htm#2004* and *http://www.ftc.gov/reports/index.htm#2006.* In July 2005, OMB approved the FTC's plan to conduct a consumer pilot study to evaluate the feasibility of directly involving consumers in a review of the information in their credit reports (OMB Control No. 3084-0133). 3 As discussed below, FTC staff believes it is necessary to conduct a follow-up pilot study to evaluate additional design elements prior to carrying out a nationwide survey on the accuracy and completeness of consumer credit reports. The additional design elements would permit the FTC to further assess whether certain data pertinent to credit report accuracy can be obtained in a way that is not unduly resource-intensive or otherwise cost-prohibitive if extended to a nationwide survey. As was true of the initial study, the follow-up pilot study will not rely on the selection of a nationally representative sample of consumers and statistical conclusions will not be drawn. 3 *See* 70 FR 24583 (May 10, 2005) (design of initial pilot study and related public comments). Under the Paperwork Reduction Act (“PRA”), 44 U.S.C. 3501-3520, federal agencies must obtain approval from OMB for each collection of information they conduct or sponsor. On October 19, 2006, the FTC sought comment on the information collection requirements associated with the proposed follow-up pilot study. 4 As discussed below, three comments were received. Pursuant to the OMB regulations that implement the PRA (5 CFR Part 1320), the FTC is providing this second opportunity for public comment while seeking OMB approval to reinstate the clearance for the pilot study, which expired in September 2006. 5 All comments should be filed as prescribed in the ADDRESSES section above, and must be received on or before March 8, 2007. 4 71 FR 61776. 5 The clearance was originally set to expire in December 2006. However, rather than seek a straight extension of the existing clearance in order to conduct the proposed follow-up pilot study, FTC staff asked OMB to discontinue the clearance in September 2006. This procedural approach ensured that the FTC's December 2006 Report to Congress, which includes the contractor's report on initial pilot study, would be publicly available before the expiration of the comment period regarding the October 19, 2006 Notice. *See* 71 FR 61776. 1. Description of the Collection of Information and Proposed Use A. Initial Pilot Study The goal of the initial pilot study was to assess the feasibility of directly engaging consumers in an in-depth review of their credit reports for the purpose of identifying alleged material errors and attempting to resolve such disputed items through the Fair Credit Report Act (“FCRA”) dispute resolution process (see below). The FTC's contractor for the initial pilot study engaged 30 randomly selected participants in an in-depth review of their credit reports. By using the Web site “myfico.com,” study participants obtained their credit reports and credit scores from each of the three nationwide consumer reporting agencies (Equifax, Experian, and TransUnion—hereinafter, the “CRAs”). After the research team evaluated consumer alleged errors for materiality, consumers were asked to channel disputed items through the FCRA dispute resolution process. 6 6 Section 611 of the FCRA (15 U.S.C. § 1681i) sets forth the process by which a consumer may dispute data in his or her credit files with a CRA, and the CRA's duty to investigate the dispute. Section 623(b) (15 U.S.C. § 1681s-2(b)) spells out the duties of persons that have furnished disputed items of information to a CRA, after receiving notice of a dispute from the CRA. The FCRA dispute resolution process thus involves the review of disputed items by data furnishers and CRAs, and the process renders a specific outcome for each alleged error. By direct instruction of the data furnisher, the following outcomes may occur: delete the item, change or modify the item (specifying the change), or maintain the item as originally reported. Also, a CRA may delete a disputed item due to expiration of statutory time frame (the FCRA limits the process to 30 days, but the time may be extended to 45 days if the consumer submits relevant information during the 30-day period). The CRAs track these possible actions by using a form called “Online Solution for Complete and Accurate Reporting” (e-OSCAR). *See* , Federal Trade Commission and Board of Governors of the Federal Reserve System, Report to Congress on the Fair Credit Reporting Act Dispute Process, August 2006. The report is available at *http://www.ftc.gov/reports/index.htm#2006.* Some of the contractor's key findings concerning the methodology of the initial pilot study include:
(i)Participants were successfully engaged in conducting a thorough and effective review of their credit report information over the telephone;
(ii)effective mechanisms to protect consumers, personal information can be employed, 7 and
(iii)sufficient information was provided for a subsequent analysis of the accuracy of items placed in CRA files and presented in credit reports. 8 7 In the protocols of the pilot study, participants were not required to reveal their social security numbers (“SSNs”) to University members of the research team, who conducted all interviews. Using normal Web site procedures, only Fair Isaac received SSNs upon an initial request for credit reports at “myfico.com.” All financial account numbers were truncated to 3 or 4 digits in any information available to University researchers. More generally, the contractor used procedures that avoided identification of study participants to CRAs and data furnishers. 8 *See* December 2006 Report and its appendix, which includes the contractor's report on the initial pilot study (available at *http://www.ftc.gov/reports/index.htm#2006).* The contractor identified two matters that would need to be addressed further: additional procedures to help consumers follow through with the entirety of the study, and additional ways of identifying and recruiting consumers to become participants in the study. The majority of participants who alleged errors on their credit reports and indicated that they would file a formal dispute did not follow through with their intention to file. Considering that this was also true for those who alleged material errors in the expert opinion of the research team, the need to explore how to best follow-up with consumers who indicate they will file a dispute is clear. Further, the outcome of the study suggests that people who did not have Internet access or experience may have been less willing to participate. Although the contractor would have offered to provide Internet access to otherwise qualified participants, all the consumers who ultimately became participants in the study had Internet access. 9 In consideration of these and other matters, the FTC plans to conduct a follow-up pilot study. 9 A broad spectrum of credit scores was attained in the study group, but the distribution tended toward relatively higher credit scores. The contractor compared participants' credit scores to the national distribution, and the study data revealed that low scores were underrepresented in the sample, while high scores were over-represented. B. Follow-Up Pilot Study In many respects, the design of the follow-up study will be similar to the initial pilot study. The elements of the proposed follow-up study are as follows:
(i)A study group of 120 consumers will be drawn by a randomized procedure that is screened to consist of adult members of households to whom credit has been extended in the form of credit cards, automobile loans, home mortgages, or other forms of installment credit. The FTC will send a letter to potential study participants describing the nature and purpose of the pilot study. The contractor will screen consumers by conducting telephone interviews. Consumers who qualify and agree to participate will sign a prepared consent form giving the contractor permission to review the consumer's credit reports.
(ii)In selecting the study group, the contractor will use, and may also experiment with, a variety of methods for recruiting participants. In addition to the randomized selection procedure used in the initial pilot study (which made use of telephone directories), the contractor may engage consumers through referrals from financial institutions as they apply for credit, *e.g.* , mortgages, automobile loans, or other forms of credit. (Lenders will know—and have a permissible purpose for knowing—the consumer's credit score and certain other characteristics; consumers can then be informed of the FTC study and invited to participate.) The contractor may employ additional methods for securing participation, provided that no method would violate the permissible purposes for obtaining a consumer's credit report (FCRA sec. 604).
(iii)The selected study group will consist of consumers having a diversity of credit scores over three broad categories: poor, fair, and good. The contractor will monitor the respective processes of recruitment so as to attain approximately equal representations of credit scores across the designated categories.
(iv)The contractor will help participants obtain their credit reports from the CRAs. Each participant will request his or her three credit reports on the same day, although different participants will generally request their reports on different days.
(v)The contractor will help the participants review their credit reports by resolving common misunderstandings that they may have about the information in their reports; this will involve educating the consumers wherever appropriate (thereby helping them to distinguish between accurate and inaccurate information).
(vi)The contractor will help participants locate any material differences or discrepancies among their three reports and check whether these differences indicate inaccuracies.
(vii)The contractor will facilitate a participant's contact with CRAs and data furnishers as necessary to help resolve credit report items that the participant views as inaccurate. To the extent necessary, the contractor will guide participants through the dispute process established by the FCRA. The contractor will not directly contact CRAs or data furnishers during the course of the study, as the outcome of a dispute may still be pending. The contractor will determine whether any changes in the participant's credit score result from changes in credit report information. 10 10 In making this comparison, the contractor will not just obtain a new credit report and score from the relevant CRAs after items have been corrected (although such reports will be obtained). The contractor is required to have the expertise to re-score the original credit report in the context of those changes directly related to the contractor's review, thereby re-scoring the consumer's “frozen file.” This method addresses the concern that changes in credit scores retrieved from CRAs could be the result of the addition of new items rather than corrected items.
(viii)For study participants who have alleged material errors and expressed an intention to file a dispute but do not file within 6 weeks, the contractor will prepare draft dispute letters on their behalf (together with stamped envelopes, pre-addressed to relevant CRAs). The contractor will ascertain from the consumer whether the letter correctly describes the consumer's allegation and, upon confirmation, the participant will be asked to sign and send the letter. As was true of the initial study, the proposed follow-up pilot study is not intended to replicate normal circumstances under which consumers generally review their credit reports; nor is it intended to evaluate the adequacy or complexity of the dispute process. The scrutiny applied to the reports of study participants, with the help of expert advice, would not at all be indicative of a consumer's normal experience in reviewing a credit report. The FTC recognizes that consumers often are not familiar with credit reporting procedures and may have difficulties in understanding a credit report (which may be partly due to a consumer's own misconceptions). Also, as noted above, some consumers may need extra guidance and help in completing the process of filing disputes for alleged errors. In all of the proposed activities, the contractor will again use procedures that avoid identification of study participants to CRAs and data furnishers. As was further true of the initial study, the proposed follow-up pilot study will not employ a specific definition of accuracy and completeness and no decision has been made on the definition of these terms for a nationwide survey. 11 Instead, both the initial and follow-up pilot studies seek to assess a methodology that involves consumer review of credit reports and both seek to ascertain the variety of information pertinent to accuracy and completeness that can be garnered. Finally, the follow-up pilot study will list an array of possible outcomes for items reviewed on the participants' credit reports. FTC staff anticipates this list will include the following categories (the contractor may supply additional categories as warranted by matters encountered in the study): 11 *See also* December 2004 Report at 5 n.10, which discusses different definitions of completeness, and at 16-18, which discusses FCRA accuracy and completeness requirements. “disputed by consumer and deleted due to expiration of statutory [FCRA] time frame;” “disputed by consumer and data furnisher agrees to delete the item;” “disputed by consumer and data furnisher agrees to change or modify the item;” “disputed by consumer and data furnisher disagrees, maintaining the item to be correct;” “item not disputed by consumer;” or “item not present on the report.” 12 12 The FTC staff recognizes the different reporting cycles of data furnishers and the voluntary basis on which information is reported to a CRA. There may be different explanations why an anticipated item is not on a particular credit report. The item may be missing because a data furnisher did not provide the information to a certain CRA, or—due to the specific reporting cycle of the data furnisher—because it was provided at a time after the credit report was viewed by the consumer. Alternatively, the item may have been submitted to a CRA but placed in the wrong consumer's file. The contractor will seek to determine, to the extent practicable, which of these explanations may apply. For example, at the end of the study the contractor may contact XYZ Mortgage, give a brief explanation of the FTC's pilot study, and inquire whether this furnisher normally reports information to Credit Bureau A; if so, then inquire about the timing of the reporting cycle. When making such inquiries, the contractor will not disclose the identities of study participants. As discussed in the December 2006 Report (at 7), which recognizes that the results of the dispute process do not establish the “accuracy” of credit reports in an absolute sense, it is still anticipated that these categories will be useful in designing a nationwide survey regardless of how “accuracy” and “completeness” may be delineated for such a survey. C. Summary of Public Comments The FTC received three comments on the proposed follow-up pilot study; one from ACA International (“ACA”), another from the Consumer Data Industry Association (“CDIA”), and a third from TransUnion, LLC (“TransUnion”). 13 The comments from each of these organizations are addressed below. 13 The comments are available on the FTC's Web site at *http://www.ftc.gov/os/comments/FACTA-accuracystudy-2/index.htm.* 1. ACA Comment 14 14 ACA (at 1) describes itself as an international trade organization of credit and collection companies that provide a variety of accounts receivable management services. ACA supports the goal of both the initial and proposed follow-up pilot study (ACA at 5), while it also expresses concerns. ACA (at 5-7) views it as a shortcoming that the pilot study design does not include definitions of the terms “accuracy,” “completeness,” or “dispute,” and does not categorize the types of data furnishers who may be addressed by a dispute. The terms “accuracy” and “completeness” do not require specific definition at this time for the following reason: the pilot studies are not used to draw any conclusions, statistical or otherwise, about accuracy or completeness but are formulated solely as vehicles for assessing the feasibility of a certain study methodology (i.e., an assessment of a consumer survey approach that directly involves consumers in a review of information in their credit reports for the purpose of identifying alleged materials errors and attempting to resolve disputed items through the FCRA dispute resolution process). As discussed above, it is anticipated that the related categories outlined in this notice will be useful in designing a nationwide survey regardless of how the terms accuracy and completeness may be delineated for such a survey. Regarding ACA's question about the term “dispute” and a classification for “data furnisher,” staff uses these terms—expressly for the purpose of the pilot studies—in the following way: in regard to items on a credit report, a “disputed item” is a consumer alleged error that is communicated by the consumer, either in writing or electronically, to a CRA or to a data furnisher; a “data furnisher” is simply a party who provides to a CRA any of the items that appear on a credit report. 15 In giving this description, staff sees no need to classify, at this stage, the types of data furnishers who may be involved with consumer disputed items. 16 15 In offering this description, staff is not proposing any legal determination of duties or actions that may be required of a CRA or a data furnisher under the FCRA. 16 In preparation for the Commission's stated goal of classifying credit report errors by type and seriousness in terms of potential consumer harm ( *see* , December 2006 Report at 2), it is expected that the studies will rank categories of credit report information according to the frequency of consumer disputes and determined errors. This type of ranking may be expected to render, concurrently, some categorization of corresponding data furnishers. 2. CDIA Comment The CDIA expresses support for FTC's plan to continue testing a methodology for a prospective nationwide study (CDIA at 1), and it also gives comment on a number of related matters. For purposes of staff's response, we summarize CDIA's concerns as follows:
(1)specific concerns and advice pertaining to the design of a nationwide survey,
(2)concerns with the contractor's report on the completed pilot study in relation to the proposed follow-up pilot study, and
(3)concerns that some of the activities of the study may fall outside the scope of the mandate given to the FTC by Section 319 of the FACT Act. FTC staff addresses each of these areas in turn. Regarding the design of a nationwide survey, CDIA (at 2-4) raises many matters, including the selection of sample participants and institutions that may be involved in helping to identify potential participants, appropriate sample size for a national survey, potential sample bias, and the need to ensure that the sample of credit reports utilized in a national survey have a distribution of credit scores representative of the national distribution. In connection with all of these matters, CDIA's overriding request appears to be (CDIA at 2) that the FTC present a national survey design for public comment. FTC staff has no disagreement with CDIA regarding these stated concerns but believes that a staff response would presently be premature. The design for a nationwide study depends in part on what the proposed follow-up pilot study reveals. More generally, staff affirms that a proposed design for a nationwide survey will be made publicly available. 17 17 Staff anticipates that upon completion of the follow-up pilot study, a subsequent design for a nationwide survey will be submitted for OMB clearance. As is also true of the present matter, the clearance process involves two **Federal Register** Notices which set forth the design elements of the study. Each notice provides opportunity for public scrutiny and comment. Regarding the work-product contained in the contractor's report, CDIA objects to some of the ways in which data were presented, and it disagrees with certain views and recommendations of the contractor (CDIA at 4-6). Before responding to these matters, staff notes that in order to have a transparent study process in connection with Section 319 of the FACT Act, the FTC made public the entirety of the contractor's report on the initial pilot study (appendix to the FTC's December 2006 Report to Congress). In the same report to Congress (at 2-4), the FTC brought forward those salient features in the contractor's report that were used in proposing a follow-up pilot study. Overall, staff believes that CDIA raises two or three matters that relate to both the work-product of the contractor and the FTC's formulation of a follow-up pilot study; these are discussed below. 18 18 The December 2006 Report (at 1) noted that the work-product and opinions of the contractor are not necessarily findings or opinions of the FTC. Staff sees no fruitful purpose to respond to matters in the contractor's report that were not used to formulate the follow-up study. As described in section B(vi) above, when conducting the proposed follow-up pilot study, the FTC anticipates that the contractor will help participants to locate any material differences or discrepancies among their three credit reports and to check whether these differences indicate inaccuracies. In regard to this proposed study design element, CDIA (at 6-7) strongly objects to using a “cross-file analysis * * * publishing score range differences * * *” for the initial study or for the proposed follow-up pilot study. Staff agrees with CDIA that differences in credit scores across a consumer's credit reports (including very substantial differences) need not indicate errors. Given the voluntary basis on which information is reported to a CRA, ( *see* note 12 above), there may be various explanations for differences in credit report information. Nonetheless, a score difference is relevant to the study if this score difference should be based on informational differences or discrepancies arising from some error in a consumer's credit files. (Staff anticipates that certain credit score ranges will be used to categorize the impact of determined errors; see discussion below.) A second matter raised by CDIA that pertains to both the work-product of the contractor and the formulation of a follow-up pilot study involves the meaning of the term material and score ranges used for assessing materiality. CDIA (at 5) notes that certain credit score ranges were used by the contractor in assessing potential materiality. 19 For the follow-up pilot study, FTC staff anticipates that disputed information will likely be categorized incrementally in terms of 10 point movements in score changes derived from a re-scoring of frozen files. 20 19 Based upon staff discussion with the contractor, the contractor viewed an alleged error as material if a re-scoring of the frozen file in regard to the challenged item yielded a change of approximately 30 points (deeming the later score range to be a commonly accepted estimate of normal variation in credit scores across a consumer's three credit reports). However, any consumer who wanted to dispute an item, regardless of anticipated impact, could do so and would be instructed on how to file. The contractor would summarize the results for all disputed items, as categorized by a re-scoring of frozen files to obtain the materiality of alleged errors. But the paucity of filed disputes that occurred in the initial pilot study rendered the procedures for assessing and reporting the materiality of disputed items as largely moot. 20 We distinguish between disputed items and determined errors. The categorization of disputed items would start with items having an expected impact of 10 points or more, then 20 points, 30 points, and so forth. The various outcomes of the dispute process would also be summarized in terms of these same categories, including any actual changes in credit scores that arise from determined errors (those alleged inaccuracies that the dispute process confirms as being errors). As noted above in connection with design element B(vii), actual changes in scores retrieved from CRAs could be the result of the addition of new items rather than corrected items, so that these actual score changes need not correctly convey the impact of an error in a credit report. Hence, we categorize outcomes by using credit score ranges that refer to a re-scoring of frozen files. CDIA (at 5) also inquires how the study will address items that remain unresolved after the dispute process is complete; i.e., items for which a data furnisher maintains the information to be accurate but the consumer maintains it is not. Staff does not intend that the study would resolve such items and anticipates that the study will identify certain items (in terms of the categories of credit report information and their frequency) that remain unresolved. As noted in the FTC's December 2006 Report (at 7), knowing the results of the dispute process does not establish the accuracy of credit reports in an absolute sense. Yet, a study using the dispute process appears to be the only feasible way of performing a study of credit report accuracy, in view of the enormous difficulty and cost of attempting to ascertain the ultimate accuracy regarding alleged errors. CDIA also comments on the mandate given by Section 319 of the FACT Act and maintains that such matters as comparing scores across credit bureaus (as discussed above), attempting to ascertain why consumers do not dispute alleged inaccuracies, and engaging non-English speaking consumers in a review of their credit reports, all fall outside the scope of the Act (CDIA at 7). FTC staff disagrees. Staff believes that all of the design elements set forth regarding the follow-up pilot study (section B above) fall within the two-prong scope of the mandate: to study the accuracy and completeness of credit report information and to study methods for improving the accuracy and completeness of such information. 3. TransUnion Comment Beyond the support expressed for CDIA's comments, TransUnion's comment letter conveys critical concern and advice in four main areas:
(1)Disappointment that the FTC has not defined the terms accuracy and completeness in the context of the present studies,
(2)concern that the FTC's scope in executing the mandate of Section 319 of the FACT Act appears to be limited to the three nationwide credit bureaus (Equifax, Experian, and TransUnion),
(3)advice that, since Fair Isaac has recently developed a subsidiary that acts as a consumer reporting agency, Fair Isaac should not play a part in any follow-up study, and
(4)a request that any person who has disputed credit report information in the past be excluded from the follow-up study. In the above discussion of ACA's concerns, staff has explained why the terms “accuracy” and “completeness” do not require definitions in the context of these pilot studies; the same response serves as a reply to TransUnion's comment on this matter. Regarding TransUnion's question (at 2) about the scope of the study on the variety of consumer reporting agencies encompassed under section 319 of the FACT Act, staff notes that the proposed pilot study does indeed involve credit reports and scores from Equifax, Experian, and TransUnion. We recognize there are many consumer reporting agencies, but credit reports from the three nationwide CRAs are the most widely used in making credit, insurance, and employment decisions. Staff has not foreclosed the possibility of recommending that additional consumer reporting agencies may be included in a broader survey. As noted above, any design for a nationwide study will, in due course, be made available for public comment. TransUnion also requests (at 2) that Fair Isaac not be part of the contracting team for any follow-up study. The background for TransUnion's request appears to be that Fair Isaac has recently developed a new credit score (an “Expansion Score”) in regard to which a subsidiary of Fair Isaac acts as a consumer reporting agency. As described by the company, 21 this score has been developed for credit grantors in connection with consumers who have insufficient credit histories to render the traditional FICO-based scores that are used by the nationwide CRAs. 21 Description obtained from Fair Isaac's Web site at *www.fairisaac.com* . Staff has considered this matter and does not think TransUnion's stated concern would justify excluding Fair Isaac from the bidding process for a follow-up pilot study. 22 In the initial study, all participants had credit histories that were evaluated by traditional FICO-based scores, and Fair Isaac's role was limited to using its expert knowledge of these scores in connection with a re-scoring of participants' frozen files for consumer alleged errors. 23 In evaluating the proposals for the extended pilot from various contractors, staff will consider how susceptible a proposal may be to possible bias in the data collection process. 22 Presently, no determination has been made about a contract award. FTC staff anticipates that a contract will be let out for competitive bidding during the spring of 2007. 23 *See* , 70 FR 24583 (May 10, 2005) on the design of the initial pilot study on this mater. The follow-up pilot study has the same design element ( *i.e.* , element B(vii), note 10.) Staff further notes that prospective participants are screened to consist of adult members of households to whom credit has been extended in the form of credit cards, automobile loans, home mortgages, or other forms of installment credit (design element B(i)). Typically, such consumers have credit histories capable of evaluation by traditional credit bureau scores. Finally, TransUnion (at 2) requests that anyone who has disputed credit report information in the past be excluded from the follow-up study, further adding that individuals who have already alleged an error at an earlier time should not be allowed to use the study as a means to recast their issues or complaints. Staff has several observations here. If it should be that some items may be “re-disputed” (as TransUnion suggests), the outcome for such disputes would follow from whatever normal procedures may be employed. For example, if a CRA has a reasonable basis for deeming a dispute frivolous, it can advise the consumer so and decline to act further. Or, if a CRA can identify the dispute as being a “re-dispute” of an already considered matter, it can again advise the consumer accordingly. Such responses would be part of the outcome of the study. On the other hand, should a CRA not have a readily available way of identifying “re-disputed” items, then neither would the contractor. More generally, staff sees no basis for restricting the study to the reports of consumers who have never disputed any item prior to the study. It is possible that the accuracy of credit reports may differ based on items that have, or have not been, disputed. In light of this, staff plans to include a question in the study about whether consumers have disputed any item in one of their credit reports at an earlier time, and if so, to briefly indicate when and what. But a currently alleged error need not be related to a prior dispute, and we do not see any justification for excluding all consumers who have disputed some item(s) in the past. Staff adds that an important element of both the initial and proposed pilot study is that any contractor must have the expertise to evaluate alleged errors and to assess whether a dispute would be material to creditworthiness. In this context, it is very unlikely that frivolous or immaterial disputes would go forward. 2. Estimated Hours Burden Consumer participation in the follow-up pilot study would involve an initial screening and any subsequent time spent by participants to understand, review, and if deemed necessary, to dispute information in their credit reports. The FTC staff estimates that up to 800 consumers may need to be screened through telephone interviews to obtain 120 participants, and that a screening interview may last up to 10 minutes, yielding a total of approximately 133 hours (800 screening interviews × 1/6 hour per contact). With respect to the hours spent by study participants, in some cases the relative simplicity of a credit report may render little need for review and the consumer's participation may only be an hour. For reports that involve difficulties, it may require a number of hours for the participant to be educated about the report and to resolve any disputed items. For items that are disputed, the participant must submit a dispute form, identify the nature of the problem, present verification from the consumer's own records to the extent possible, and perhaps submit further information. As was true of the initial study, FTC staff again estimates the participants' time for reviewing their credit reports at an average of 5 hours per participant, resulting in a total of 600 hours (5 hours × 120 participants). 24 Total consumer burden hours are thus approximately 750 hours (derived as 133 screening hours plus 600 participant hours, further rounding upwards to the nearest 50 hours). 24 This estimate is given for the purpose of calculating burden under the PRA. Information contained in the contractor's report regarding the initial study may indicate a somewhat lower estimate of the average time spent by the 30 participants, but it would not render a noticeably different result for the overall consumer burden. In an effort not to underestimate the time spent by additional study participants, FTC staff has retained the estimate used for the initial study. 3. Estimated Cost Burden The cost per participant should be negligible. Participation is voluntary, and will not require any start-up, capital, or labor expenditures by study participants. As with the initial study, participants will not pay for their credit reports or credit scores. William Blumenthal, General Counsel. [FR Doc. E7-1837 Filed 2-5-07; 8:45 am] BILLING CODE 6750-01-P GENERAL SERVICES ADMINISTRATION [Docket 2007-0006, Sequence 1] Privacy Act of 1974; Notice of Updated System of Records AGENCY: General Services Administration ACTION: Updated Notice. SUMMARY: The General Services Administration
(GSA)is providing notice of an update to the record system Personnel Security Files (GSA/HRO-37). The system provides control over personnel security. The update ensures that the system of records meets the requirements of Homeland Security Presidential Directive 12 (HSPD-12) and that individuals be fully informed about collection of their personal information. EFFECTIVE DATE: The system of records will become effective without further notice on March 8, 2007 unless comments received on or before that date result in a contrary determination. FOR FURTHER INFORMATION CONTACT: Call or e-mail the GSA Privacy Act Officer: telephone 202-208-1317; e-mail *gsa.privacyact@gsa.gov* . ADDRESSES: GSA Privacy Act Officer (CIB), General Services Administration, 1800 F Street NW, Washington, DC 20405. SUPPLEMENTARY INFORMATION: To comply with new requirements of Homeland Security Presidential Directive 12 (HSPD-12), GSA updated its personnel security system. This notice explains the new categories of records in the system and the authorities for maintaining the system. Dated: January 29, 2007. Cheryl Paige, Acting Director, Office of Information Management. GSA/HRO-37 System name: Personnel Security files. Security classification: Some records in the system are classified under Executive Order 12958 as amended. System location: Personnel security files are maintained with other appropriate records in the Personnel Security Requirements Division (CPR), GSA Building, 1800 F Street NW, Washington, DC 20405. Categories of individuals covered by the system: Employees, applicants for employment, former employees of GSA and of commissions, committees, small agencies serviced by GSA, contractors, students, interns, volunteers, individuals authorized to perform or use services provided in GSA facilities ( *e.g.* , Credit Union or Fitness Center) and individuals formerly in any of these positions that require regular, ongoing access to federal facilities, information technology systems or information classified in the interest of national security. Included are historical researchers, experts or consultants, and employees of contractors performing services for GSA. Categories of records in the system: Personnel security files contain information such as name, former names, date and place of birth, home address, phone numbers, height, weight, hair color, eye color, sex, passport information, military information, civil court information, employment history, residential history, Social Security Number, occupation, experience, and investigative material, education and degrees earned, names of associates and references and their contact information, citizenship, names of relatives, citizenship of relatives, names of relatives who work for the federal government, criminal history, mental health history, drug use, financial information, fingerprints, summary report of investigation, results of suitability decisions, level of security clearance, date of issuance of security clearance, requests for appeals, witness statements, investigator's notes, tax return information, credit reports, security violations, circumstances of violation, and agency action taken. Forms: SF-85, SF-85P, SF-86, SF-87, GSA Form 3665, OF306, FD258. Authority for maintaining the system: Depending upon the type of investigation, GSA is authorized to ask for this information under Executive Orders 10450 as amended, 10865 as amended, 12968 as amended, and 12958 as amended; sections 3301 and 9101 of title 5, U.S. Code; sections 2165 and 2201 of title 42, U.S. Code; parts 5, 731, 732, and 736 of title 5, Code of Federal Regulations; and Homeland Security Presidential Directive 12. Purpose: To assemble in one system information pertaining to issuing security clearances and public trust certifications, suitability decisions, fitness for service of applicants for federal employment and contract positions, and administrative actions. Information security files also are used for recommending administrative action against employees found to be violating GSA classified national security information regulations. Routine uses of records in the system, including the types of users and the purposes of such uses: a. In any legal proceeding, where pertinent, to which GSA is a party before a court or administrative body. b. To the Department of Justice when:
(a)the agency or any component thereof; or
(b)any employee of the agency in his or her official capacity;
(c)any employee of the agency in his or her individual capacity where agency or the Department of Justice has agreed to represent the employee; or
(d)the United States Government, is a party to litigation or has an interest in such litigation, and by careful review, the agency determines that the records are both relevant and necessary to the litigation and the use of such records by DOJ is therefore deemed by the agency to be for a purpose compatible with the purpose for which the agency collected the records. c. To authorized officials engaged in investigating or settling a grievance, complaint, or appeal filed by an individual who is the subject of the record. d. Except as noted on Forms SF-85, 85-P, and 86, when a records on its face, or in conjunction with other records, indicates a violation or potential violation of law, whether civil, criminal, or regulatory in nature, and whether arising by general statute or particular program statute, or by regulation, rule, or order issued pursuant thereto, disclosure may be made to the appropriate public authority, whether Federal, foreign, State, local or tribal, or otherwise, responsible for enforcing, investigating or prosecuting such violation or charged with enforcing or implementing the statute, or rule, regulation, or order issued pursuant thereto, if the information disclosed is relevant to any enforcement, regulatory, investigative or prosecutorial responsibility of the receiving entity. e. To a Federal agency in connection with the hiring or retention of an employee; the issuance of a security clearance; the reporting of an investigation; the letting of a contract; or the issuance of a grant, license, or other benefit to the extent that the information is relevant and necessary to a decision. f. To agency contractors or volunteers who have been engaged to assist the agency in the performance of a contract service, cooperative agreement, or other activity related to this system of records and who need to have access to the records in order to perform their activity. Recipients shall be required to comply with the requirements of the Privacy Act of 1974, as amended, 5 U.S.C. 552a. g. To the Office of Personnel Management (OPM), the Office of Management and Budget (OMB), or the Government Accountability Office
(GAO)when the information is required for program evaluation purposes. h. To a Member of Congress or staff on behalf of and at the request of the individual who is the subject of the record. i. To an expert, consultant, or contractor of GSA in the performance of a Federal duty to which the information is relevant. j. To the National Archives and Records Administration
(NARA)for records management purposes. k. To a federal, state, or local agency, or other appropriate entities or individuals, or through established liaison channels to selected foreign governments, in order to enable an intelligence agency to carry out its responsibilities under the National Security Act of 1947 as amended, the CIA Act of 1949 as amended, Executive Order 12333 or any successor order, applicable national security directives, or classified implementing procedures approved by the Attorney General and promulgated pursuant to such statutes, orders, or directives. l. To the Office of Management and Budget when necessary to the review of private relief legislation pursuant to OMB Circular No. A-19. Policies and practices for storing, retrieving, accessing, retaining, and disposing of records in the system: Storage: Records are maintained on paper and electronically in secure locations. Records are maintained in the system of records Comprehensive Human Resources Integrated System (GSA/PPFM-8) in the personnel security module and associated equipment. Retrievability: Records are retrieved by name and Social Security Number. Safeguards: Personnel security file records are stored in a secured office in cabinets with access limited to authorized employees. A password system protects access to computer records. Access to the records is limited to those employees who have a need for them in the performance of their official duties. Retention and disposal: These records are retained and disposed of in accordance with General Records Schedule 18, item 22, approved by the National Archives and Records Administration (NARA). Records are destroyed by burning, pulping, or shredding, as scheduled in the HB GSA Records Maintenance and Disposition System (OAD P 1820.2A). System manager and address: The official responsible for personnel security files in the system is the Director, Personnel Security Requirements Division (CPR), 1800 F Street NW, Washington, DC 20405. Notification procedure: Inquiries by individuals as to whether the system contains a record pertaining to themselves should be addressed to the system manager. Record access procedures: Requests from individuals for access to records should be addressed to the system manager and should include full name (maiden name where appropriate), address, and date and place of birth. General inquiries may be made by telephone. Procedures for contesting records: GSA rules for accessing records, contesting their content, and appealing initial decisions appear in 41 CFR part 105-64. Record sources: Individuals, employees, informants, law enforcement agencies, other Government agencies, employees' references, co-workers, neighbors, educational institutions, and intelligence sources. Security violation information is obtained from a variety of sources, such as security guard's reports, security inspections, witnesses, supervisor's reports, and audit reports. Files exempted from parts of the act: Under 5 U.S.C. 552a(k)(5), the personnel security case files in the system of records are exempt from subsections (c)(3); (d); (e)(1); (e)(4)(G), (H), and (I); and
(f)of the act. Information will be withheld to the extent it identifies witnesses promised confidentiality as a condition of providing information during the course of the background investigation. [FR Doc. E7-1866 Filed 2-5-07; 8:45 am] BILLING CODE 6820-34-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Food Defense Workshop; Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop. SUMMARY: The Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA), Southwest Regional Office (SWRO), in co-sponsorship with the University of Arkansas
(UA)Institute of Food Science and Engineering (IFSE), is announcing a public workshop entitled “Food Defense Workshop.” This public workshop is intended to provide information about food defense, the regulations authorized by the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act), and other related subjects to FDA-regulated food facilities (farms, manufacturers, processors, distributors, retailers, and restaurants). *Date and Time* : This public workshop will be held on May 23 through 24, 2007, from 8 a.m. to 5 p.m. *Location* : The public workshop will be held at the Continuing Education Center, 2 East Center St., Fayetteville, AR (located downtown). *Contact* : David Arvelo, Food and Drug Administration, Southwest Regional Office, 4040 North Central Expressway, suite 900, Dallas, TX 75204, 214-253-4952, FAX: 214-253-4970, or e-mail: *david.arvelo@fda.hhs.gov* . For information on accommodation options, contact Steven C. Seideman, 2650 North Young Ave., Institute of Food Science and Engineering, University of Arkansas, Fayetteville, AR 72704, 479-575-4221, FAX: 479-575-2165, or email: *seideman@uark.edu* . *Registration* : You are encouraged to register by May 9, 2007. The University of Arkansas has a $150 registration fee to cover the cost of facilities, materials, speakers, and breaks. Seats are limited; please submit your registration as soon as possible. Course space will be filled in order of receipt of registration. Those accepted into the course will receive confirmation. Registration will close after the course is filled. Registration at the site is not guaranteed but may be possible on a space available basis on the day of the public workshop beginning at 8 a.m. The cost of registration at the site is $200 payable to: “The University of Arkansas.” If you need special accommodations due to a disability, please contact Steven C. Seideman (see *Contact* section of this document) at least 7 days in advance. *Registration Form Instructions* : To register, please complete the following form and submit along with a check or money order for $150 payable to the “The University of Arkansas.” Mail to: Institute of Food Science and Engineering, University of Arkansas, 2650 North Young Ave., Fayetteville, AR 72704. **Food Defense Workshop Registration Form** Name: Affiliation: Mailing Address: City: State: Zip Code: Phone: ( ) FAX: ( ) E-mail: Special Accommodations Required: *Transcripts* : Transcripts of the public workshop will not be available due to the format of this workshop. Workshop handouts may be requested at cost through the Freedom of Information Office (HFI-35), Food and Drug Administration, 5600 Fishers Lane, rm. 6-30, Rockville, MD 20857, approximately 15 working days after the public workshop at a cost of 10 cents per page. SUPPLEMENTARY INFORMATION: This public workshop is being held in response to the large volume of food defense concerns from FDA-regulated food facilities (farms, manufacturers, processors, distributors, retailers, and restaurants) originating from the area covered by the FDA Dallas District Office. The Southwest Regional Office presents this workshop to help achieve objectives set forth in section 406 of the Food and Drug Administration Modernization Act of 1997 (21 U.S.C. 393), which include working closely with stakeholders and maximizing the availability and clarity of information to stakeholders and the public. This is consistent with the purposes of the Small Business Representative Program, which are in part to respond to industry inquiries, develop educational materials, sponsor workshops and conferences to provide firms, particularly small businesses, with firsthand working knowledge of FDA's guidance, requirements, and compliance policies. This workshop is also consistent with the Small Business Regulatory Enforcement Fairness Act of 1996 (Public Law 104-121), as outreach activities by Government agencies to small businesses. The goal of this public workshop is to present information that will enable FDA-regulated food facilities (farms, manufacturers, processors, distributors, retailers, and restaurants) to better comply with the regulations authorized by the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act), and with food defense guidance, especially in light of growing concerns about food defense. Information presented will be based on agency position as articulated through regulation, guidance, and information previously made available to the public. Topics to be discussed at the workshop include:
(1)Food defense awareness,
(2)ALERT: The basics,
(3)FDA actions on bioterrorism legislation (food supply),
(4)food recalls,
(5)crisis management,
(6)food defense technologies and methodologies, and other related topics. FDA expects that participation in this public workshop will provide regulated industry with greater understanding of the regulatory and policy perspectives on food defense and increase voluntary compliance and food defense awareness. Dated: January 31, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-1865 Filed 2-5-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007D-0031] Global Harmonization Task Force, Study Groups 1, 2, and 4; New Proposed and Final Documents; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration
(FDA)is announcing the availability of proposed and final documents that have been prepared by Study Groups 1, 2, and 4 of the Global Harmonization Task Force (GHTF). These documents represent a harmonized proposal and recommendation from the GHTF Study Groups that may be used by governments developing and updating their regulatory requirements for medical devices. These documents are intended to provide information only and do not describe current regulatory requirements; elements of these documents may not be consistent with current U.S. regulatory requirements. FDA is requesting comments on these documents. DATES: Submit written or electronic comments on any of the proposed documents by May 7, 2007. After May 7, 2007, written comments or electronic comments may be submitted at any time to the contact persons listed in this document. ADDRESSES: Submit written requests for single copies of the documents to the Division of Small Manufacturers, International, and Consumer Assistance (HFZ-220), Center for Devices and Radiological Health, Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850. Send one self-addressed adhesive label to assist that office in processing your request, or fax your request to 301-443-8818. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. Submit written comments concerning this guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to *http://www.fda.gov/dockets/ecomments* . Identify comments with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: *For Study Group 1* : Ginette Y. Michaud, Chairperson, GHTF, Study Group 1, Office of Device Evaluation, Center for Devices and Radiological Health (HFZ-480), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 240-276-3700. *For Study Group 2* : Mary Brady, GHTF, Study Group 2, Office of Surveillance and Biometrics, Center for Devices and Radiological Health (HFZ-530), Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850, 240-276-3458. *For Study Group 4* : Jacqueline Welch, GHTF, Study Group 4, Office of Compliance, Center for Devices and Radiological Health (HFZ-320), Food and Drug Administration, 2094 Gaither Rd., Rockville, MD 20850, 240-276-0115. SUPPLEMENTARY INFORMATION: I. Background FDA has participated in a number of activities to promote the international harmonization of regulatory requirements. In September 1992, a meeting was held in Nice, France by senior regulatory officials to evaluate international harmonization. This meeting led to the development of the organization now known as the GHTF to facilitate harmonization. Subsequent meetings have been held on a yearly basis in various locations throughout the world. The GHTF is a voluntary group of representatives from national medical device regulatory authorities and the regulated industry. Since its inception, the GHTF has been comprised of representatives from five founding members grouped into three geographical areas: Europe, Asia-Pacific, and North America, each of which actively regulates medical devices using its own unique regulatory framework. The objective of the GHTF is to encourage convergence at the global level of regulatory systems of medical devices to facilitate trade while preserving the right of participating members to address the protection of public health by regulatory means considered most suitable. One of the ways this objective is achieved is by identifying and developing areas of international cooperation to facilitate progressive reduction of technical and regulatory differences in systems established to regulate medical devices. In an effort to accomplish these objectives, the GHTF formed five study groups to draft documents and carry on other activities designed to facilitate global harmonization. This notice is a result of documents that have been developed by three of the Study Groups (1, 2, and 4). Study Group 1 was initially tasked with the responsibility of identifying differences between various regulatory systems. In 1995, the group was asked to propose areas of potential harmonization for premarket device regulations and possible guidance that could help lead to harmonization. As a result of its efforts, this group has developed proposed document SG1(PD)N044:2006. SG1(PD)N044:2006 (proposed document), entitled “Role of Standards,” provides guidance on the use of standards by a manufacturer when designing a medical device and, subsequently, when demonstrating the device conforms to relevant essential safety and performance criteria. FDA seeks comment on the document and particularly “Section 5.2 Revision or Replacement of Recognised Standards.” This section addresses the use of a recognized standard during the transitional period when it is being replaced by a revised version. Study Group 4 was initially tasked with the responsibility of developing guidance documents on quality systems auditing practices. As a result of its efforts, this group has developed document SG4(PD)N33R13:2006. SG4(PD)N33R13:2006 (proposed document), entitled “Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers—Part 3: Regulatory Audit Reports,” suggests a structure for audit reports used in multiple jurisdictions, promoting consistency and uniformity and should assist the auditor in preparing a report for use by multiple regulators and/or auditing organizations. Having reports that are consistent in content should facilitate the review and exchange of audit reports. Acceptance of audit reports by multiple regulators should eventually reduce the number of audits for manufacturers. Study Group 2 was initially tasked with the responsibility of developing guidance documents that will be used for the exchange of adverse event reports. As a result of its efforts, this group developed SG2N54R8:2006. SG2N54R8:2006 (final document), entitled “Medical Devices Post Market Surveillance: Global Guidance for Adverse Event Reporting for Medical Devices,” provides guidance on the type of adverse events associated with medical devices that should be reported by manufacturers to a National Competent Authority. It elaborates on the regulatory requirements existing in the participating member countries. II. Significance of Guidance These documents represent recommendations from the GHTF study groups and do not describe regulatory requirements. FDA is making these documents available so that industry and other members of the public may express their views and opinions. III. Electronic Access Persons interested in obtaining a copy of the documents may also do so by using the Internet. The Center for Devices and Radiological Health
(CDRH)maintains an entry on the Internet for easy access to information including text, graphics, and files that may be downloaded to a personal computer with Internet access. Updated on a regular basis, the CDRH home page includes device safety alerts, **Federal Register** reprints, information on premarket submissions (including lists of approved applications and manufacturers' addresses), small manufacturer's assistance, information on video conferencing and electronic submissions, Mammography Matters, and other device-oriented information. Information on the GHTF may be accessed at *http://www.ghtf.org* . The CDRH web site may be accessed at *http://www.fda.gov/cdrh* . IV. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES ), written or electronic comments regarding these documents. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Comments received may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Dated: January 30, 2007. Linda S. Kahan, Deputy Director, Center for Devices and Radiological Health. [FR Doc. E7-1864 Filed 2-5-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Proposed Collection Comment Request In compliance with the requirement for opportunity for public comment on proposed data collection projects (section 3506(c)(2) of Title 44, United States Code, as amended by the Paperwork Reduction Act of 1995, Public Law 104-13), the Health Resources and Services Administration
(HRSA)will publish periodic summaries of proposed projects being developed for submission to the Office of Management and Budget
(OMB)under the Paperwork Reduction Act of 1995. To request more information on the proposed project or to obtain a copy of the data collection plans, call the HRSA Reports Clearance Officer on
(301)443-1129. Comments are invited on:
(a)Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility;
(b)the accuracy of the agency(s estimate of the burden of the proposed collection of information;
(c)ways to enhance the quality, utility, and clarity of the information to be collected; and
(d)ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Proposed Project: Reporting Form for the MCHB National Hemophilia Program Grantees and Hemophilia Treatment Center
(HTC)Affiliates Having Factor Replacement Product
(FRP)Programs—NEW The Maternal and Child Health Bureau
(MCHB)of the Health Resources and Services Administration
(HRSA)is planning to implement an annual reporting form required of grantees of the MCHB National Hemophilia Program and their HTC affiliates having a factor replacement product
(FRP)program. The purpose of the form is to provide systematic information and data comprising a financial overview of the FRP programs of the HTCs receiving funding through grantees of the MCHB National Hemophilia Program. The proposed form will constitute a reporting requirement for the MCHB National Hemophilia Program grantees and their affiliate HTCs having FRP programs. Data from the form will provide quantitative information on the financial and services provision aspects of each of the HTC FRP programs under each of the MCHB National Hemophilia Program grantees, specifically:
(a)Patient FRP program participation,
(b)FRP program revenue,
(c)FRP program costs,
(d)FRP program net income, and
(e)use of FRP program net income. This form will provide data useful to grantees and their affiliate HTCs having FRP programs. Useful data will also be provided to the MCHB National Hemophilia Program in order to assess FRP program performance including FRP program operational costs appropriateness, FRP program cost efficiency, and FRP program services benefits-information that is essential to evaluating HTCs having FRP programs, grantees, and the MCHB National Hemophilia Program. Each HTC having an FRP program is to submit its report to the grantee and each grantee is to submit the individual reports of each of their affiliate HTCs having an FRP program to the MCHB National Hemophilia Program as a part of their annual grant application. The burden estimate for this project is as follows: Form Number of respondents Average number of responses per respondent Total responses Hours per response Total burden hours Factor Replacement Product
(FRP)Data Sheet 68 1 68 30 2040 Send comments to Susan G. Queen, Ph.D., HRSA Reports Clearance Officer, Room 10-33 Parklawn Building, 5600 Fishers Lane, Rockville, Maryland 20857. Written comments should be received within 60 days of this notice. Dated: January 29, 2007. Caroline Lewis, Acting Associate Administrator for Administration and Financial Management. [FR Doc. E7-1824 Filed 2-5-07; 8:45 am] BILLING CODE 4165-15-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Proposed Collection: Comment Request In compliance with the requirement for opportunity for public comment on proposed data collection projects (section 3506(c)(2)(A) of Title 44, United States Code, as amended by the Paperwork Reduction Act of 1995, Public Law 104-13), the Health Resources and Services Administration
(HRSA)publishes periodic summaries of proposed projects being developed for submission to the Office of Management and Budget
(OMB)under the Paperwork Reduction Act of 1995. To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, call the HRSA Reports Clearance Officer on
(301)443-1129. Comments are invited on:
(a)Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility;
(b)the accuracy of the agency's estimate of the burden of the proposed collection of information;
(c)ways to enhance the quality, utility, and clarity of the information to be collected; and
(d)ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Proposed Project: “Health Care and Other Facilities” Construction Program: Web-Based Status Reporting Form: NEW The Health Resources and Services Administration's Health Care and Other Facilities
(HCOF)construction program provides earmarked funds to health-related facilities for construction-related activities and/or capital equipment purchases. Awarded facilities are required to provide a periodic (quarterly for construction-related projects, annually for equipment only projects) update of the status of the funded project until it is completed. The monitoring period averages about 3 years, although some projects take up to 5 years to complete. The information collected from these updates is vital to program management staff to determine whether projects are progressing according to the established timeframes, meeting deadlines established in the Notice of Grant Award (NGA), and funds are drawn down appropriately. The data collected from the updates is also shared with both the Division of Grants Management Operations
(DGMO)and the Division of Engineering Services (DES), so that they can assist in the overall evaluation of each project's progress. A Web-based form has been developed for progress reporting for the HCOF program. This form will provide awardees access to directly input the required status update information in a timely, consistent, and uniform manner. The Web-based form will minimize burden to respondents and will inform respondents when there are missing data elements prior to submission. The estimate of burden for the forms is as follows: Project type (current) Number of respondents Responses per respondent Total responses Hours per response Total burden hours Construction-Related 325 4 1,300 .5 650 Equipment Only 357 1 357 .5 178.5 Total 682 1,657 828.5 Project type (FY 07-09 projection) Number of respondents Responses per respondent Total responses Hours per response Total burden hours Construction-Related* 498 4 1,992 .5 996 Equipment Only** 925 1 925 .5 462.5 Total 1,423 2,917 1,458 Send comments to Susan G. Queen, Ph.D., HRSA Reports Clearance Officer, Room 10-33, Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857. Written comments should be received within 60 days of this notice. Dated: January 29, 2007. Caroline Lewis, Acting Associate Administrator for Administration and Financial Management. [FR Doc. E7-1825 Filed 2-5-07; 8:45 am] BILLING CODE 4165-15-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Proposed Collection; Comment Request In compliance with the requirement for opportunity for public comment on proposed data collection projects (section 3506 (c)(2)(A) of Title 44, United States Code, as amended by the Paperwork Reduction Act of 1995, Pub. L. 104-13), the Health Resources and Services Administration
(HRSA)publishes periodic summaries of proposed projects being developed for submission to the Office of Management and Budget
(OMB)under the Paperwork Reduction Act of 1995. To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, call the HRSA Reports Clearance Officer at 301-443-1129. Comments are invited on:
(a)Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility;
(b)the accuracy of the agency's estimate of the burden of the proposed collection of information;
(c)ways to enhance the quality, utility, and clarity of the information to be collected; and
(d)ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Proposed Project: Women's Physical Activity and Healthy Eating Tools Assessment: NEW The HRSA Office of Women's Health
(OWH)developed the *Bright Futures for Women's Health and Wellness (BFWHW)* Initiative to help expand the scope of women's preventive health activities, particularly related to nutrition and physical activity. An intermediate assessment of the *BFWHW* health promotion consumer materials related to physical activity and healthy eating will be conducted in order to assess how the *BFWHW* materials can stimulate a conversation on physical activity and healthy eating during a clinical encounter; inform future *BFWHW* programming, and add to the peer-reviewed literature regarding women's health and wellness initiatives. Towards this end, anonymous assessment forms will be used to collect data from young and adult women clients, health care providers, and administrators of health centers. Data collected will include process and outcome measures. Data domains include: The distribution and use of the materials in the health care setting during wellness and health maintenance/check-up visits; client and provider awareness of physical activity and nutrition behaviors; attitudes about the importance of physical activity and nutrition; self-efficacy; and increase in knowledge and intent to change physical activity and nutrition behaviors. A total of six organizations, which may include Federally Qualified Health Centers/Community Health Centers, faith-based organizations that offer health care services, worksite health centers, and school-based health clinics, will be selected for the study. Young women will complete anonymous assessment forms at school-based health centers; adult women will be assessed at other health care organizations. The providers at these sites will also be asked to complete a brief one-time anonymous assessment form. Telephone interviews will be conducted with an administrator of each of these sites as well. The data collection period at each site is estimated to last four months. The estimated response burden is as follows: Estimated Data Collection Burden Hours Data collection activity Number of respondents Hours per response Responses per respondent Total burden hours Hourly wage rate Total cost Clients 3,000 1.00 1 3,000 $5.15 $15,450.00 Administrators 6 4.25 1 25.50 37.09 945.80 Support Staff 6 64.00 1 384 13.65 5,241.60 Providers 60 6.00 1 360 59.15 21,294.00 Total 3,072 3,769.5 $42,931.40 Send comments to Susan G. Queen, Ph.D., HRSA Reports Clearance Officer, Room 10-33, Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857. Written comments should be received within 60 days of this notice. Dated: January 29, 2007. Caroline Lewis, Acting Associate Administrator for, Administration and Financial Management. [FR Doc. E7-1841 Filed 2-5-07; 8:45 am] BILLING CODE 4165-15-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Indian Health Service Privacy Act of 1974; Report of Modified or Altered System—Indian Health Service Scholarship and Loan Repayment Programs AGENCY: Indian Health Service (IHS). ACTION: Notice of Proposed Modification or Alteration to a System of Records (SOR). SUMMARY: In accordance with the requirements of the Privacy Act of 1974, the Indian Health Service
(IHS)is proposing to modify or alter a SOR, “Indian Health Service Scholarship and Loan Repayment Programs,” System No. 09-17-0002. We propose to modify the SOR to reflect current program changes, technology changes, statutory and implementation changes. Under the system name, we propose no change to the title but the office acronyms have been changed as a result of an organizational change. We are proposing to change the system location to reflect the current organizational and office location changes. We are proposing to update the categories of individuals covered by the system with minor edits to include Tribal medical/health care and Title V Urban healthcare entity; and to update the categories of records in the system with edits to include additional program requirements “(e.g. from W-4, direct deposit form for scholarship recipients and loan repayment participants).” We are proposing to update the Authority for maintenance of the system to correct statutory authorities and to include additional statutory authorities (e.g., Privacy Act, Federal Records Act, and Department Regulations). We are proposing to update the Purposes by categorizing the two programs and modifying/altering by listing the applicable purposes into each of the two programs (Scholarship and Loan Repayment). We are proposing to modify/alter/delete several published routine uses, as explained, to accommodate program and statutory changes as indicated: Numbers 1 through 3 remain unchanged; number 4 is modified/altered to reflect program language revisions and is renumbered as 5; number 5 is modified to include legal proceedings related to administrative claims and the inclusive provision of the Department of Health and Human Services (DHHS)/Office of General Counsel
(OGC)representation in litigation matters and is renumbered as 4; number 6 is deleted as no longer applicable; number 7 is renumbered as 6 with no changes in the wording; number 8 is renumbered as 7 with no changes in the wording; number 9 is renumbered as 8 with no changes in the wording; number 10 is renumbered as 9 with minor editorial changes; number 11 is renumbered as 10 with minor editorial changes to include the IHCIA acronym citation (i.e., Indian Health Care Improvement Act, as amended); number 12 is renumbered as 11 with no changes in the wording with the exception of the removal of the statement on “Disclosure to Consumer Reporting Agencies.” We are proposing to add 7 new routine uses to provide disclosures of records when all requirements are met: number 12, to provide disclosure to consumer reporting agency for commercial credit report and to National Student Clearinghouse using the Loan Location Internet System for verification of applicant's loan data. The statement on “Disclosure to Consumer Reporting Agencies” is now incorporated in this new routine use; number 13, to provide disclosure to any Federal agency on delinquent debtors or defaulting participants to effect salary offset, court-ordered administrative offset, and to the Treasury Department, Internal Revenue Service
(IRS)for verification of current mailing address for collection purposes; number 14, to allow disclosure to debt collection agents and those authorized federal or non-federal entities to collect a Federal debt from delinquent debtors or defaulting participants; number 15, to provide disclosure of applicant's information to IRS for verification of any delinquent tax account and to determine credit worthiness; number 16, to provide disclosure of applicant's information to IRS any debt that becomes partly or wholly uncollectible as taxable income; number 17, to allow disclosure to IRS of any IHS debtors or defaulting participants' information for IRS offset on tax refund; number 18, to allow the disclosure of lenders or educational institutions' information to Federal or non-Federal entities authorized to collect Federal debt and for identification of an individual and the nature of the debt. We are proposing to modify/alter the section on storage by including computerized and electronic formats; the section on safeguards for authorized users by redefining the staff functions; the section on physical safeguards to identify specific safeguards for electronic records; and the section on retention and disposal to reflect separate program changes to the IHS Records Schedule for the scholarship program records and to the loan repayment program records. We are proposing to modify/alter the section on the system managers and addresses to reflect the organization and function changes. Under the notification procedures, we are proposing to modify/alter the sections on requests in person and requests by mail to reflect minor edits and a policy change on Social Security numbers; and the section on requests by telephone by revising the wording in a clear and concise program change. In addition, we are proposing two new notification procedures that address requests by facsimile and requests by electronic mail by including a confidentiality statement on facsimile requests and clarification for electronic requests and its security safeguard risks. Under the records source categories section, we are proposing to modify/alter by including the Indian health program human resources department. This system exemption previously listed as “None” will remain. DATES: *Effective Dates:* The Report of Intent to Amend a System of Records Notice and an advance copy of the system notice have been sent to the Chair of the House Committee on Government Reform and Oversight, the Chair of the Senate Committee on Governmental Affairs, and the Administrator, Office of Information and Regulatory Affairs, Office of Management and Budget (OMB). To ensure that all parties have adequate time in which to comment, the modified system of records, including routine uses, will become effective 40 days from the publication of the notice, or from the date it was submitted to OMB and the Congress, whichever is later, unless IHS receives comments that require alterations to this notice. ADDRESSES: The public should address comments to: Mr. William Tibbitts, IHS Privacy Act Officer, Division of Regulatory Affairs, Records Access and Policy Liaison, Office of Management Services, 801 Thompson Avenue, TMP, Suite 450, Rockville, MD 20852-1627; call non-toll free
(301)443-1116; send via facsimile to
(301)443-2316, or send your e-mail requests, comments, and return address to: *William.Tibbitts@ihs.gov.* FOR FURTHER INFORMATION CONTACT: Ms. Patricia Lee-McCoy, Director, Division of Health Professions Support, Office of Public Health Support, 801 Thompson Avenue, TMP, Suite 450A, Rockville, MD 20852-1627, Telephone
(301)443-4242. SUPPLEMENTARY INFORMATION: A. Major Modification of 09-17-0002, “Indian Health Service Scholarship and Loan Repayment Programs, HHS/IHS/OPHS/DHPS”: is to reflect the organizational, program, technology, statutory and implementation changes. 1. IHS is proposing to update the purposes by categorizing the two programs and listing the applicable purposes into each of the two programs. 2. IHS is proposing to modify/alter/delete several published routine uses and to include seven
(7)new routine uses when all requirements have been met. IHS is modifying/altering routine use #4 to reflect program revisions and is renumbered as #5; routine use #5 is modified to include legal proceedings related to administrative claims and in the inclusive provision of the Department of Health and Human Service (DHHS)/Office of General Counsel
(OGC)representation in litigation matters and is renumbered as #4; routine use #6 is deleted as no longer applicable; routine use(s) #7, 8, 9, 10, 11, and 12 are renumbered as #6, 7, 8, 9, 10, and 11 respectively. IHS is proposing to add seven
(7)new routine uses as follows: Routine use #12 is to provide disclosure to consumer reporting agency for commercial credit report and to National Student Clearinghouse using the Loan Location Internet System; routine use #13 is to provide disclosure to any federal agency on delinquent debtors or defaulting participants to effect salary offset, court-ordered administrative offset, and to the Treasury Department, Internal Revenue Service (IRS); routine use #14 is to allow disclosure to debt collection agents and authorized federal and non-federal entities for collection purposes; routine use #15 is to provide disclosure of applicant's information to IRS for verification and credit worthiness; routine use #16 is to provide disclosure of applicant's information to IRS on uncollectible debt as taxable income; routine use #17 is allow disclosure to IRS of any IHS debtors or defaulting participants' information for IRS offset on tax refund; and routine use #18 is to allow disclosure of lenders or educational institutions' information to federal or non-federal entities to collect Federal debt, identification of an individual and the nature of the debt. In addition to updating and making editorial corrections to improve the clarity of the system notice, this alteration requires the updating of the system manager listing, and revisions of the Categories of Records, Purposes, Authority, Safeguard, Retention and Disposal, Notification and Access Procedures sections. IHS is proposing to add two
(2)new notification procedures by addressing requests by facsimile and requests by electronic mail. Dated: January 31, 2007. Charles W. Grim, Assistant Surgeon General, Director, Indian Health Service. Department of Health and Human Resources 09-17-0002 System name: Indian Health Service Scholarship and Loan Repayment Programs, HHS/IHS/OPHS/DHPS. Security classification: None. System location: Office of Public Health Support (OPHS), Division of Health Professions Support (DHPS), Scholarship Branch, Loan Repayment Branch, Health Professions Support Branch, Indian Health Service, 12300 Twinbrook Parkway, Suite 450A, Rockville, MD 20852. Washington National Records Center, 4205 Suitland Road, Suitland, MD 20746-8001. Records are also located at the Indian Health Service
(IHS)Area Offices. A list of the IHS Area Offices where individually identifiable data are currently located is available upon request to the Policy-Coordinating Official(s) at IHS Headquarters East, 12300 Twinbrook Parkway, Suite 450A, Rockville, MD 20852. Categories of individuals covered by the system: Applicants for and recipients of benefits from scholarship and loan repayment programs administered by the IHS. The IHS scholarship program includes the Health Professions Pre-Graduate Scholarship Program for Indians, the Health Professions Preparatory Scholarship Program for Indians; and the Health Professions Scholarship Program for Indians. Also included are records of scholarship or loan repayment recipients who are fulfilling their IHS service obligations as a result of receiving funds from these IHS programs, and individuals who have an expressed and/or obligated interest in employment in or an assignment to an IHS medical facility, Tribal medical/health care facility, Title V urban healthcare entity, or other facility described in sections 104 and 108 of the Indian Health Care Improvement Act, as amended (IHCIA). Categories of records in the system: Contains: Name, telephone number(s), work, school, home and/or mailing address; Social Security number; IHS scholarship or IHS loan repayment application; associated forms; employment data; professional performance and credentialing history of licensed health professionals; preference for site selection; personal, professional, and demographic background information; progress reports (which include related data, correspondence, and professional performance information); payroll forms; lender's loan repayment confirmation forms; Form W-4 (for withholding Federal taxes on scholarship recipients monthly stipends); IHS loan recipient's direct deposit form request (for monthly stipends for scholarship recipients and for annual loan repayment distribution among participants in the programs); deferment and placement data; and repayment/delinquent/default status information. Authority for maintenance of the system: 25 U.S.C. 1613, including the Health Professions Preparatory Scholarship Program for Indians; 25 U.S.C. 1613a, Indian Health Professions Scholarship; 25 U.S.C. 1616a, IHS Loan Repayment Program; 5 U.S.C. 5514, Requirement That Applicant Furnish Taxpayer Identifying Number; 42 U.S.C. 216(a), for PHS Commissioned Corps Officers, and 5 U.S.C. 3301 for civil service employees, both of which authorize verification of an individual's suitability for employment; Federal Records Act “44 U.S.C. 2901 et seq.”; Privacy Act of 1974, as amended (5 U.S.C. 552a); Department Regulation “5 U.S.C. 301”; and 42 U.S.C. 254f, Assignment of Corps Personnel. Purpose(s): The purposes of this system of records are as follows: 1. *The IHS Scholarship Programs.*
(a)To select applicants for the IHS Scholarship Programs;
(b)To monitor scholarship related activities, such as payment tracking, deferment and/or postponement of service obligations owed default, placement, and debt collection through national credit company subscription(s);
(c)To select and match IHS scholarship recipients for qualified employment assignments with the following: IHS medical facilities, including but not limited to hospitals, health clinics and ambulatory stations; and any other programs as required under 25 U.S.C. 1616a;
(d)To monitor services provided by these IHS scholarship recipient/participant/obligated health care providers;
(e)To maintain records on and to verify individuals' credentials, educational background, prior and current performance history and data and previous and current employment and professional history information to verify and validate all claimed credentials are current, accurate, and in good standing;
(f)To assist Department of Health and Human Services (DHHS), Program Support Center
(PSC)and other government officials in the collection of any and all overdue debts owed under the IHS Scholarship Program; and
(g)To negotiate site assignments, and to recruit and retain health professionals for Indian Health programs. Portions of records from this system of records may be used by staff of the DHHS/PSC; Division of Financial Operations (DFO), Debt Management, who maintain System No. 09-40-0012, “Debt Management and Collection System” and System No. 09-90-0024, “Unified Financial Management System”, for activities related to the participant's breach of contract including debt collection information provided to PSC staff includes, but may not be limited to the participant's personal identification, number of years of support in school while covered by an IHS scholarship contract, number of days served and still owed, and amount of funds expended and still owed. 2. *The IHS Loan Repayment Agreement Program* .
(a)To select applicants for the IHS Loan Repayment Program;
(b)To monitor loan repayment related activities including but not limited to service obligations, default and claims determinations;
(c)To assure IHS loan repayment recipients match to a health care facility serving high priority health professional shortage areas or populations as outlined by current IHS scoring criteria policy and procedure, such as IHS medical facilities, including but not limited to hospitals, health clinics and ambulatory stations; and any other programs as required under 25 U.S.C. 1616a;
(d)To monitor service provided by IHS loan repayment participants;
(e)To maintain records on and to verify individuals' credentials and educational background;
(f)To assist PSC and other governmental officials in the collection of overdue debts owed under the IHS Loan Repayment Agreement Program; and
(g)To negotiate site assignments, and recruit and retain health professionals for Indian Health programs. Portions of records from this system of records may be used by staff of the DHHS/PSC; Division of Financial Operations (DFO), Debt Management, who maintain System No. 09-40-0012, “Debt Management and Collection System” and System No. 09-90-0024, “Unified Financial Management System”, for activities related to the participant's breach of contract including debt collection information provided to PSC staff includes, but may not be limited to the participant's personal identification, number of days served and still owed, and amount of funds expended and still owed. Routine uses of records maintained in the system, including categories of users and the purposes of such uses: 1. IHS may disclose records to a congressional office in response to a verified inquiry from the congressional office made at the written request of the subject individual. 2. Records may be disclosed to authorized persons employed by the grantee institution (the educational institution which the recipient of a scholarship grant is attending or the hospital affiliated with an educational institution the IHS loan repayment recipient is attending to complete his or her residency requirement) as needed for the administration of a scholarship grant award. 3. Records may be disclosed to other Federal agencies that also provide scholarship funding at the request of these Federal agencies to detect or curtail fraud and abuse in Federal scholarship programs, and to collect delinquent loans or benefit payments owed to the Federal Government. 4. IHS may disclose information from these records in litigations and/or proceedings related to an administrative claim when:
(a)IHS has determined that the use of such records is relevant and necessary to the litigation and/or proceedings related to an administrative claim and would help in the effective representation of the affected party listed in subsections
(i)through
(iv)below, and that such disclosure is compatible with the purpose for which the records were collected. Such disclosure may be made to the DHHS/Office of General Counsel
(OGC)and/or Department of Justice (DOJ), pursuant to an agreement between IHS and OGC, when any of the following is a party to litigation and/or proceedings related to an administrative claim or has an interest in the litigation and/or proceedings related to an administrative claim:
(i)DHHS or any component thereof; or
(ii)Any DHHS employee in his or her official capacity; or
(iii)Any DHHS employee in his or her individual capacity where the DOJ (or DHHS, where it is authorized to do so) has agreed to represent the employee; or
(iv)The United States or any agency thereof (other than DHHS) where HHS/OGC has determined that the litigation and/or proceedings related to an administrative claim is likely to affect DHHS or any of its components.
(b)In the litigation and/or proceedings related to an administrative claim described in subsection
(a)above, information from these records may be disclosed to a court or other tribunal, or to another party before such tribunal in response to an order of a court or administrative tribunal, provided that the covered entity discloses only the information expressly authorized by such order. 5. IHS may provide to any organization, program or facility administered under the authority of the IHCIA (Pub. L. 93-437, 25 U.S.C. 1601 et seq.) solely to provide health care services for the benefit of Indians, whether directly by our service; or by any federally recognized Tribe under authority of the Indian Self-Determination and Education Assistance Act (ISDEAA) (Pub. L. 93-638, as amended, 25 U.S.C. 450 et seq.); a list of obligated recipients of scholarship grants, and any relevant information pursuant to recruiting and retaining these individuals for the purpose of meeting the health care needs of the requesting organization, program, facility or the federally recognized Tribe under IHCIA and ISDEAA. 6. IHS may disclose records consisting of names, disciplines, current mailing addresses, and dates of graduation of scholarship recipients and loan repayment program participants to IHS discipline representatives, IHS and Tribal scholarship coordinators, and Indian health program health professional recruiters for the purpose of mentoring students during their training, assisting them to find appropriate positions upon completion of their training, and helping them to understand the nature of their professional service obligation. IHS may disclose records consisting of names of the IHS scholarship or IHS loan repayment recipient, professional school he or she is attending, and the date of graduation to Indian health programs as defined by the IHCIA; health professions associations and other interested health professions groups which have responsibility for coordinating funds paid to students from Federal and other sources. 8. IHS may disclose records contained in this system of records to HHS contractors and subcontractors for the purpose of collecting, compiling, aggregating, analyzing, or refining records in the system. Contractors and/or subcontractors are required to maintain Privacy Act safeguards with respect to such records. 9. IHS may disclose records contained in this system of records to HHS contractors and subcontractors for the purpose of recruiting, screening, and matching health/allied health professionals for assignment to or employment in a medical facility located in one of the options cited in section 108(a)(2)(A) of the IHCIA. In addition, HHS contractor and subcontractors:
(a)May disclose biographic data and information supplied by potential applicants;
(i)To references listed on application and associated forms for the purpose of evaluating the applicant's professional qualifications, experience, and suitability; and
(ii)To a state or local Government medical licensing board and/or to the Federation of State Medical Boards or a similar non-Government entity for the purpose of verifying that all claimed background and employment data are valid and all claimed credentials are current and in good standing.
(b)May disclose biographic data and information supplied by references listed on application and associated forms to other references for the purpose of inquiring into the applicant's professional qualifications and suitability; and
(c)May disclose professional suitability evaluation information to IHS officials, prospective employers, or to officials of prospective employers, or to site representatives, for the purpose of appraising the applicant's professional qualifications and suitability for site assignment or employment. Contractors and/or subcontractors are required to maintain Privacy Act safeguards with respect to such records. 10. IHS may disclose records contained in this system of records to private parties such as present and former employers references listed on application and associated forms, other references, and education institutions. The purpose of such disclosures is to obtain information to evaluate an individual's professional accomplishments, performance, and educational background, and to determine if an applicant is suitable for employment in/assignment to a medical facility located at one of the sites listed in section 108(a)(2)(A) of the IHCIA. 11. IHS may disclose records contained in this system of records to other Federal agencies that also provide scholarship or educational loan repayment funding at the request of these Federal agencies in conjunction with a computer matching program conducted by these Federal agencies to detect or curtail fraud and abuse in Federal scholarship or educational loan repayment programs, and to collect delinquent loans or benefit payments owed to the Federal Government. 12. IHS may disclose information from this system of records to a consumer reporting agency (credit bureau) to obtain an applicant's or participant's commercial credit report for the following purposes:
(1)To establish his or her credit worthiness;
(2)to assess and verify his or her ability to repay debts owed to the Federal Government; and
(3)to determine and verify the eligibility of loans submitted for repayment. IHS may also disclose information from this system of records to the National Student Clearinghouse using the Loan Locator Internet System or similar system to assist in the verification of loan data submitted by Loan Repayment Program
(LRP)applicants. Disclosures are limited to the individual's name, address, Social Security number and other information necessary to identify him or her; locate all student loans and verify payment addresses; identify the funding being sought or amount and status of the debt; and the program under which the applicant or claim is being processed. Disclosure to consumer reporting agencies: Disclosures pursuant to 5 U.S.C. 552a(b)(12): Disclosures may be made from this system to “consumer reporting agencies” as defined in the Fair Credit Reporting Act (15 U.S.C. 158a(f)) or the Federal Claims Collection Act of 1966 (31 U.S.C. 3701(a)(3)). The purposes of these disclosures are:
(1)To provide an incentive for debtors to repay delinquent Federal Government debts by making these debts part of their credit records; and
(2)to enable PHS agencies to improve the quality of loan and scholarship decisions by taking into account the financial reliability of applicants. Disclosure of records will be limited to the individual's name, social security number, and other information necessary to establish the identity of the individual, the amount, status, and history of the claim, and the agency or program under which the claim arose. 13. IHS may disclose from this system of records a delinquent debtor's or a defaulting participant's name, address, social security number, and other relevant information necessary to identify him or her; the amount, status, and the history of the claim; and the agency or program under which the claim arose, as follows:
(a)To any Federal agency to effect a salary offset for debts owed by Federal employees; if the claim arose under the Social Security Act, and the employee must have agreed in writing to the salary offset with the supporting document from the requesting Federal agency.
(b)To any Federal agency to effect authorized administrative offset; i.e., withhold money, other than Federal salaries, payable to or held on behalf of the individual that is court ordered and/or in accordance with a specific law/mandate.
(c)To the Treasury Department, Internal Revenue Service (IRS), to request an individual's current mailing address to locate him or her for purposes of either collecting or compromising a debt or to pay a commercial credit report prepared. 14. IHS may disclose to debt collection agents, other Federal agencies, and other third parties who are authorized to collect a Federal debt, information necessary to identify a delinquent debtor or a defaulting participant. Disclosure will be limited to the individual's name, address, social security number, and other information necessary to identify him or her; the amount, status, and history of the claim; and the agency or program under which the claim arose. 15. IHS may disclose to the IRS information about an individual applying for the IHS loan repayment or scholarship program authorized by the Public Health Service Act to find out whether the applicant has a delinquent tax account. This disclosure is for the sole purpose of determining the applicant's creditworthiness and is limited to the individual's name, address, social security number, and other relevant information necessary to identify him or her, and the program for which the information is being obtained. 16. IHS may report to the IRS, as taxable income, the written-off amount of a debt owed by an individual to the Federal Government when a debt becomes partly or wholly uncollectible, either because the time period for collection under statute or regulations has expired, or because the government agrees with the individual to forgive or compromise the debt. 17. IHS may disclose from this system of records to the Department of Treasury, IRS:
(1)A delinquent debtor's or a defaulting participant's name, address, social security number, and other relevant information necessary to identify the individual;
(2)the amount of the debt; and
(3)the program under which the debt arose, so that the IRS can offset against the debt any income tax refunds which may be due to the individual. 18. IHS may disclose information provided by the lender or education institution to other Federal agencies, debt collection agents, and other third parties who are authorized to collect a Federal debt. The purpose of this disclosure is to identify an individual who is delinquent in loan or benefit payments owed to the Federal Government and the nature of the debt. Policies and practices for storing, retrieving, accessing, retaining, and disposing of records in the system: Storage: Records are maintained in paper format (i.e., file folders), and in computerized and electronic format (i.e., forms, database(s), etc.). Retrievability: Records which identify individual persons are indexed by name or assigned identification number of scholarship or loan repayment applicant or recipient. Safeguards: 1. *Authorized users:* Access is limited only to authorized personnel in the performance of their duties. Authorized personnel include and are limited to: The system manager, his or her staff, IHS Area Office Scholarship or IHS Loan Repayment Coordinators, IHS Headquarters Branch Chiefs while acting as advisors to scholarship or IHS loan repayment recipients, and PSC debt management staff for activities related to the participant's breach of contract including debt collection. 2. *Physical safeguards:* Paper records are stored in locked file cabinets. The records storage areas are secured during off-duty hours. Electronic records are stored in areas where fire and life safety codes are strictly enforced. Any and all records pertaining to IHS Scholarship and Loan Repayment Program databases are to be enforced by the current Security Guidelines provided by HHS/IHS. All automated and non-automated documents are protected during lunch hours and non-working hours in locked file cabinets or locked storage areas. The Automated Data Processing remote stations are locked during non-standard working hours. Twenty-four hour, 7-day security guards perform random checks on the physical security of the data and the storage areas. Backup files are maintained in an off-site facility with controlled entrances and exits. 3. *Procedural safeguards:* All IHS personnel who make use of records contained in this system are made aware of their responsibilities under the provisions of the Privacy Act and are required to maintain Privacy Act safeguards with respect to such records. The records storage areas are not left unattended during office hours, including lunch hours. Records are not removed from these areas in which they are maintained in the absence of proper charge-out procedures. Twenty-four hour, seven-day security guards perform random checks on the physical security of all records storage areas. A data set name controls the release of data to only authorized users. When copying records for authorized purposes, care is taken to ensure that any imperfect pages are not left in the reproduction room where they can be read, but are destroyed or obliterated. Retention and disposal: 1. Scholarship applications of individuals not selected for participation in the program are retained for 1 full year, and then destroyed by shredding. Applications, contracts, and other records of IHS scholarship recipients are retained through the completion or other disposition of the scholarship service obligation, then sent to the Federal Records Center
(FRC)for an additional 15-year retention period and destroyed in accordance with FRC disposal standards. Automated historical tapes are sent to a FRC and the initial records are destroyed in accordance with IHS Records Control Schedule. The records for the scholarship applicants, who are not obligated to the IHS, are destroyed 6 years and 3 months after final payment, or upon resolution of any adverse audit findings, whichever is later. 2. Loan repayment applications of individuals not selected for participation in the program are retained until the end of the fiscal year. Loan repayment applications, upon notification, are applied to the loan repayment cycle of the following fiscal year. The records for the loan repayment participants are destroyed 6 to 10 years after the final payment, or upon resolution of any adverse audit findings, whichever is later. Records are transferred to the FRC 2 years after final repayment or when closed, for 4 years, and are then subsequently disposed of in accordance with the IHS Records Disposition Schedule. The IHS Records Disposition Schedule regulations for these records may be obtained by writing to the System Manager(s) at the address listed below. System manager(s) and address: Policy Coordinating Official(s): Director, Division of Health Professions Support, Office of Public Health Support, Indian Health Service, 12300 Twinbrook Parkway, Suite 450A, Rockville, Maryland 20852. Director, Division of Grants Operations, Office of Management Services, Indian Health Service, 12300 Twinbrook Parkway, Suite 360, Rockville, Maryland 20852. Chief, Scholarship Branch, Division of Health Professions Support, Office of Public Health Support, Indian Health Service, 12300 Twinbrook Parkway, Suite 450A, Rockville, Maryland 20852. Chief, Loan Repayment Branch, Division of Health Professions Support, Office of Public Health Support, Indian Health Service, 12300 Twinbrook Parkway, Suite 450A, Rockville, Maryland 20852. Notification procedures: *Requests in person:* A subject individual who appears in person at a specific location seeking access to or disclosure of records relating to him or her shall provide his or her name, current address, Grant Identification Number, last four digits of their social security number or other identification numbers, dates of enrollment in the IHS scholarship or loan repayment program, and at least one piece of tangible identification such as a driver's license, passport, or voter registration card. Identification papers with current photographs are preferred, but not required. If a subject individual has no identification, but is personally known to an agency employee, such employee shall make a written record verifying the subject individual's identity. Where the subject individual has no identification papers, the responsible agency official shall require that the subject individual certify in writing that he or she is the individual who he or she claims to be and that he or she understands that the knowing and willful request or acquisition of a record concerning an individual under false pretense is a criminal offense subject to a 5,000 dollar fine. *Requests by mail:* A written request must contain the name and address of the requestor, last 4 digits of their respective social security number and/or signature which is either notarized to verify his or her identity or includes a written certification that the requestor is the person he or she claims to be and that he or she understands that the knowing and willful request or acquisition of records pertaining to an individual under false pretenses is a criminal offense subject to a 5,000 dollar fine. In addition, the following information is needed: Dates of enrollment in the IHS Scholarship Program or IHS Loan Repayment Agreement program, and current enrollment status, such as pending application approval, deferment or service obligation, or shortage area placement. *Requests by facsimile:* A written request must contain the name and address of the requestor, last 4 digits of their respective social security number and/or signature. In addition, the following information is needed: Dates of enrollment in the IHS scholarship program or IHS Loan Repayment Agreement Program, and current enrollment status, such as pending application approval, deferment or service obligation, or shortage area placement. The IHS Scholarship and Loan Repayment programs will authorize transmission and reception of all faxed information only if the fax cover sheets contain the following Confidentiality Statement or a similar standard procedural statement for liability purposes: “THIS FAX IS INTENDED ONLY FOR THE USE OF THE PERSON OR OFFICE TO WHOM IT IS ADDRESSED, AND CONTAINS PRIVILEGED OR CONFIDENTIAL INFORMATION PROTECTED BY LAW. ALL RECIPIENTS ARE HEREBY NOTIFIED THAT INADVERTENT OR UNAUTHORIZED RECEIPT DOES NOT WAIVE SUCH PRIVILEGE, AND THAT UNAUTHORIZED DISSEMINATION, DISTRIBUTION, OR COPYING OF THIS COMMUNICATION IS PROHIBITED. IF YOU HAVE RECEIVED THIS FAX IN ERROR, PLEASE DESTROY THE ATTACHED DOCUMENT(S) AND NOTIFY THE SENDER OF THE ERROR BY CALLING.” *Requests by telephone:* Since positive identification of the caller cannot be established, telephone requests are not honored; the caller is asked to submit his or her request in writing. *Requests by electronic mail:* Since positive identification of the requestor cannot be established, and the electronic transmission of personal identifiers is not encrypted, the security safeguards is not guaranteed from an unauthorized disclosure, so electronic mail requests are not honored and will be deleted from the IHS e-mail system; and the computer user is asked to submit his or her request in writing and/or by facsimile transmission. *Record access procedures:* Same as notification procedures. Requestors should also provide a reasonable description of the record being sought. Requestors may also request an accounting of disclosures that have been made of their record, if any. Contesting record procedures: Contact the Policy Coordinating Official(s), provide a reasonable description of the record, and specify the information being contested, the corrective action sought, and the reasons for requesting the correction, along with supporting information to show how the record is inaccurate, incomplete, untimely, or irrelevant. Record source categories: Information will be collected from the following sources: Education institutions attended; internship and/or residency training progress reports; IHS site selection questionnaires; IHS Scholarship or Loan Repayment applicants; Indian health programs human resources department; financial institutions from which these applicants have obtained educational loans; Bureau of Health Professions Area Resources File tapes; health professional associations; HHS contractors/subcontractors; consumer reporting agencies/credit bureaus; lending institutions; PHS Commissioned Personnel Operations Division and U.S. Office of Personnel Operations Division and U.S. Office of Personnel Management personnel records; other Federal agencies, including but not limited to the Department of Treasury, the IRS, and the U.S. Postal Service; State or local Government medical licensing boards and/or the Federation of State Medical Boards or a similar non-Government entity; and third parties who provide references concerning the subject individual. Systems exempted from certain provisions of the Act: None. [FR Doc. 07-501 Filed 2-5-07; 8:45 am]
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Traces to 23 documents
U.S. Code
- Definitions§ 1841
- Acquisition of bank shares or assets§ 1842
- Interests in nonbanking organizations§ 1843
- Procedure in case of disputed accuracy§ 1681i
- Responsibilities of furnishers of information to consumer reporting agencies§ 1681s–2
- Records maintained on individuals§ 552a
- Food and Drug Administration§ 393
- Health professions preparatory scholarship program for Indians§ 1613
- Indian health professions scholarships§ 1613a
- Indian Health Service Loan Repayment Program§ 1616a
- Installment deduction for indebtedness to the United States§ 5514
- Regulations§ 216
- Civil service; generally§ 3301
- Definitions§ 2901
- Departmental regulations§ 301
- Corps personnel§ 254f
- Congressional findings§ 1601
- Transferred§ 450
- Definitions and application§ 3701
CFR
10 references not yet in our index
- 12 CFR 225
- Pub. L. 108-159
- 44 USC 3501-3520
- 5 CFR 1320
- 41 CFR 105
- Pub. L. 104-121
- Pub. L. 104-13
- Pub. L. 93-437
- Pub. L. 93-638
- 15 USC 158a(f)
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Cite12 CFR 225
Pub. L.Pub. L. 108-159
Cite44 USC 3501-3520
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