Department of Health and Human Services 2012 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``eCopy Program for Medical Device Submissions.'' The purpose of the draft guidance is to explain the new electronic copy (eCopy) program for medical device submissions. The draft guidance describes how FDA plans to implement the eCopy Program under the Federal Food, Drug, and Cosmetic Act (the FD&C Act). The inclusion of an eCopy is expected to improve the efficiency of the review process by allowing for the immediate availability of an electronic version for review rather than relying solely on the paper version. This draft guidance is not final nor is it in effect at this time.

This document corrects technical errors in the regulations text of the final rule that appeared in the August 31, 2012 Federal Register entitled ``Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Fiscal Year 2013 Rates; Hospitals' Resident Caps for Graduate Medical Education Payment Purposes; Quality Reporting Requirements for Specific Providers and for Ambulatory Surgical Centers'' (hereinafter referred to as the FY 2013 IPPS/LTCH PPS final rule).

The Administration for Community Living (ACL) is announcing that the proposed collection of information listed below has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

The U.S. Department of Health and Human Services (HHS) solicits written comments regarding new objectives proposed to be added to Healthy People 2020 since its launch in December 2010 and written comments proposing new objectives to be included within existing Healthy People 2020 Topic Areas. Public participation helps shape Healthy People 2020, its framework, objectives, organization, and targets. Healthy People 2020 will provide opportunities for public input periodically throughout the decade to ensure Healthy People 2020 reflects current public health priorities and public input. The updated set of Healthy People 2020 objectives will be incorporated on www.healthypeople.gov. This set will reflect further review and deliberation by the Topic Area workgroups, Federal Interagency Workgroup on Healthy People 2020, and other Healthy People 2020 stakeholders.

In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Heart, Lung, and Blood Institute (NHLBI), the National Institutes of Health (NIH), will publish periodic summaries of proposed projects to the Office of Management and Budget (OMB) for review and approval. Proposed Collection: Title: Recipient Epidemiology and Donor Evaluation Study-III (REDS-III). Type of Information Collection Request: New. Need and Use of Information Collection: The objective of the Recipient Epidemiology and Donor Evaluation Study-III (REDS-III) program is to ensure safe and effective blood banking and transfusion medicine practices through a comprehensive, multifaceted strategy involving basic, translational, and clinical research to improve the benefits of transfusion while reducing its risks. The conduct of epidemiologic, survey, and laboratory studies is the cornerstone of REDS-III and its predecessors, the REDS and REDS-II programs. Over the past 20 years, the National Heart, Lung, and Blood Institute (NHLBI) REDS programs have proven to be the premier research programs in blood collection and transfusion safety in the United States. Successive renditions of the REDS programs have built upon the many successes that this research network has realized over the years while being responsive to changing research and clinical needs, and adapting to emerging priorities. Research findings have served to improve the screening of donors and collected blood products, blood banking practices, diagnoses, and the basic science principles of transfusion medicine. While significant progress has been made, transfusion therapya very commonly used therapy affecting about six million recipients annually in the U.S.remains one of the least understood medical procedures. REDS-II conducted studies of blood donor health but much more needs to be learned, including how donor genetic or environmental factors may affect the quality of collected blood components and influence non-infectious transfusion complications in recipients. Additionally, there is always the potential that a new, emerging or re- emerging infection may pose a threat to the safety of the U.S. blood supply. Much of the success of the REDS programs was due to their ability to respond in a timely fashion to potential blood safety threats such as West Nile Virus (WNV) in 2002 or Xenotropic Murine Leukemia Virus Related Virus (XMRV) in 2009. Globally, the threat of HIV and other blood-borne infections to blood safety remains real and has to be closely monitored. Therefore, continuing collection of new scientific evidence through REDS-III is both critical to public health in the U.S. and to countries struggling with the HIV epidemic where blood safety and availability are major concerns. Additionally, the research areas encompassed in REDS-III have been and continue to be hypothesis generating, leading to the development of new basic and translational research projects with implications well beyond the fields of blood banking and transfusion medicine. REDS-III has also been charged with the tasks of education and training and integration of these components in a transfusion medicine research network. With this submission, the REDS-III Study seeks approval from OMB to develop research studies with data collection activities using focus groups, cognitive interviews, questionnaires and/or qualitative interviews following all required informed consent procedures for respondents and parents/caregivers as appropriate. With this generic clearance, study investigators will be able to use the OMB-approved data collection methods where appropriate to plan and implement time sensitive studies. Such studies that fall within the overall scope of this submission will be subjected to expedited review and approval by OMB before their implementation. Additionally, studies are reviewed by an NHLBI Observational Study Monitoring Board (OSMB) and by all relevant IRBs. Frequency of Response: Once. Affected Public: Individuals. Type of Respondents: Males and females 16 years old or older. The annual reporting burden is as follows: Estimated Number of Respondents: 6,882; Estimated Number of Responses per Respondent: 1; Average Burden of Hours per Response: 1 hour; Estimated Total Annual Burden Hours Requested: 6,826. The annualized total costs to all respondents except for the Brazil and South Africa studies are estimated at $53,964 (based on $9.00 per hour). The annualized total cost to all respondents for the Brazil and South African studies is $2,940. There are no capital, operating, or maintenance costs to the respondents.

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. This proposed information collection was previously published in the Federal Register on July 16, 2012 (FR 77, 41791) and allowed 60-days for public comment. One public comment was received and a response was sent. The comment referenced alternative research that is unrelated to cancer screening. The purpose of this notice is to allow an additional 30 days for public comment. The National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the Attention: NIH Desk Officer, Office of Management and Budget, at OIRA_ submission@omb.eop.gov or by fax to 202-395-6974. To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact Dr. Christine D. Berg, Chief, Early Detection Research Group, National Cancer Institute, NIH, EPN Building, Room 3100, 6130 Executive Boulevard, Bethesda, MD 20892, or call non-toll-free number 301-496-8544 or email your request, including your address to: bergc@mail.nih.gov. Comments regarding this information collection are best assured of having their full effect if received within 30 days of the date of this publication. Proposed Collection: Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial (PLCO), OMB No: 0925-0407, Expiration Date 9/30/2014, Revision, National Cancer Center (NCI), National Institutes of Health (NIH). Need and Use of Information Collection: This trial was designed to determine if screening for prostate, lung, colorectal, and ovarian cancer can reduce mortality from these cancers which currently cause an estimated 255,700 deaths annually in the U.S. The design is a two-armed randomized trial of men and women aged 55 to 74 at entry. OMB first approved this study in 1993 and has approved it every 3 years since then through 2014. During the first approval period a pilot study was conducted to evaluate recruitment methods and data collection procedures. Recruitment was completed in 2001, screening was completed in 2006, and data collection continues through 2016. When participants enrolled in the trial they agreed to be followed for at least 13 years from the time of enrollment. In 2011, participants were re-consented for at least an additional five years of follow-up. The current number of respondents is limited to the approximately 94,000 participants being actively followed up. This is down from the initial total. The reports on screening and prostate, lung, colorectal and ovarian cancer mortality based on this trial have been published in peer review medical journals. The additional follow-up will provide data that will clarify further the long term effects of the screening on cancer incidence and mortality for the four targeted cancers. Further, demographic and risk factor information may be used to analyze the differential effectiveness of screening in high versus low risk individuals. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 31,813.

This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR Part 404.7(a)(1)(i), that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant to Birich Technologies, Inc., of an exclusive evaluation option license to practice the inventions embodied in the following U.S. Patent Applications (and all continuing applications and foreign counterparts): Serial No. 61/045,088 entitled, ``COMPOSITIONS AND METHODS FOR DELIVERING INHIBITORY OLIGONUCLEOTIDES'' [HHS Ref. E-051- 2008/0-US-01]; Serial No. 61/333,512 entitled, ``Peptide Inhibitors of Interferon Gamma and Interleukin 10 Signaling'' [HHS Ref. E-167-2010/0- US-01]; and Serial No. 60/987,340 entitled, ``Diagnostic and Therapeutic Applications of a p53 Isoform in Regenerative Medicine, Aging and Cancer'' [HHS Ref. E-033-2008/0-US-01]. The patent rights in these inventions have been assigned or exclusively licensed to the Government of the United States of America. The prospective exclusive evaluation option license territory may be worldwide, and the field of use may be limited to:

The Administration for Children and Families (ACF), Administration for Native Americans (ANA) announces the award of a cooperative agreement in the amount of $250,000 to the Native American Fatherhood and Families Association (NAFFA) in Mesa, AZ to conduct a national outreach campaign focused on promoting the importance of fatherhood in Native communities. Included in the national outreach campaign will be a national conference, regional workshops, webinars, and a Native American Responsible Fatherhood Day that will be promoted and implemented throughout Native American communities during the month of June 2013. The award will be made under ANA's program for Social and Economic Development Strategies.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

The Presidential Commission for the Study of Bioethical Issues will conduct its eleventh meeting in November. At this meeting, the Commission will continue discussing topics related to the ethical issues associated with the development of medical countermeasures for children.

In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act (PRA) of 1995, the Office of the Secretary (OS), Department of Health and Human Services, will submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB) for review and approval. The ICR is for renewal of the approved information collection assigned OMB control number 0937-0166, scheduled to expire on December 31, 2012. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public on this ICR during the review and approval period. Deadline: Comments on the ICR must be received within 30 days of the issuance of this notice.

The Administration on Children, Youth and Families (ACYF), Family and Youth Services Bureau (FYSB), Division of Adolescent Development and Support (DADS) announces the award of single-source expansion supplement grants to nine PREIS grantees for the purpose of expanding program participation and/or sites to support the increase of data necessary to determine the level of program effectiveness. In FY 2010, FYSB awarded thirteen cooperative agreement grants under Funding Opportunity Announcement (FOA) number: OPHS/OAH/TPP PREP Tier 2-2010. Under this FOA a total of $9.7 million was made available on a competitive basis to implement and test innovative strategies. Single-source program expansion supplement awards are made to the following PREIS grantees:

In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Electronic Government Office (EGOV), Department of Health and Human Services, will submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB) for review and approval. The ICR is for renewal of the approved information collection assigned OMB control number 4040-0005, scheduled to expire on October 31, 2012. The ICR also requests categorizing the form as a common form, meaning HHS will only request approval for its own use of the form rather than aggregating the burden estimate across all Federal Agencies as was done for previous actions on this OMB control number. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public on this ICR during the review and approval period. Deadline: Comments on the ICR must be received within 30 days of the issuance of this notice.

The National Institutes of Health (NIH), as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995, Section 3506. Proposed Collection: Title: National Institutes of Health Information Collection Forms to Support Genomic Data Sharing for Research Purposes; Type of Information Collection Request: New; Need and Use of Information Collection: The NIH mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce the burdens of illness and disability. The sharing of research data supports this mission and is essential to facilitate the translation of research results into knowledge, products, practices, and procedures that improve human health. By enabling secondary research questions to be addressed, data sharing maximizes the public benefit achieved through research investments. NIH's Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies (GWAS) was established to enable the full value of GWAS data to be realized. GWAS data are maintained in a central data repository, the database of Genotypes and Phenotypes (dbGaP), which is administered by the National Center for Biotechnology Information (NCBI), part of the National Library of Medicine at NIH. As stipulated in the NIH GWAS policy, all principal investigators (PIs) who receive NIH funding to conduct genomic research are expected to register studies with genomic data in dbGaP. The nature of the genomic, phenotypic, and other associated data generated through large- scale human genomic studies requires responsible stewardship throughout research and data sharing activities. Since the data being collected and shared are from human research participants, the protection of participant interests is paramount. PIs submitting data to dbGaP must describe any limitations on sharing the data, as defined in the informed consent provided by the participants from whom the data were originally collected. PIs must also provide basic study information such as the type of data that will be submitted to dbGaP and a description of the study. Researchers interested in using dbGaP data for secondary research must submit a request through dbGaP and be granted permission from the relevant NIH Data Access Committees to access the data. As part of the request process, researchers must provide information such as a description of the proposed research use of the dbGaP datasets, a data security plan, and a Data Use Certification, in which the researcher agrees to the terms and conditions for use of the data. NIH has developed online forms, which will be available through dbGaP, in an effort to reduce the burden for researchers to complete the study registration, data submission, and data access processes. Frequency of Response: As necessary. Description of Respondents: PIs and senior officials from their institutions. Estimate of Burden: The burden associated with this information collection is calculated in two parts: (1) The burden associated with registering genomic studies and submitting data to dbGaP and (2) the burden associated with applying for genomic data in dbGaP. The annual reporting burden for study registration and data submission is as follows: Estimated Number of Respondents: 100; Estimated Number of Responses per Respondent: 1; and Estimated Total Annual Burden Hours Requested: 63. The annual cost to respondents is estimated at $2,506. The annual reporting burden for applying for genomic data in dbGaP is as follows: Estimated Number of Respondents: 1,266; Estimated Number of Responses per Respondent: 2; and Estimated Total Annual Burden Hours Requested: 1,583. The annual cost to respondents is estimated at $63,452. There are no capital, operating, or maintenance costs to the respondents.

The Administration for Children and Families (ACF), Office of Community Services (OCS) announces the award of single-source program expansion supplements to seven FY 2012 grantees under the Assets for Independence Demonstration Program (AFI). Grantees will provide an array of supports and services to enable individuals and families with low incomes to become more economically self-sufficient for the long term. A primary feature of each AFI project is that project participants are given access to special matched savings accounts called Individual Development Accounts (IDA). Participants open an IDA and save earned income in the account regularly with the goal of accumulating savings to acquire an economic asset that will appreciate over timespecifically, to purchase a home, capitalize or expand a business for self-employment, or attend higher education or training. Grantees also ensure that participants have access to financial literacy education and coaching such as training on money management and consumer issues. Grant recipients must finance the projects with a combination of the federal AFI grant and non-federal cash. The non- federal cash amount must be at least equal to the federal AFI grant amount.

The Food and Drug Administration (FDA) is requesting that industry organizations interested in participating in the selection of a nonvoting industry representative to represent the interests of tobacco growers, to serve on its Tobacco Products Scientific Advisory Committee, notify FDA in writing. A nominee may either be self- nominated or nominated by an organization to serve as a nonvoting industry representative. Nominations will be accepted for the upcoming vacancy effective with this notice.

The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) debarring Stephen C. Delaney, Jr. for a period of 5 years from importing articles of food or offering such articles for importation into the United States. FDA bases this order on a finding that Mr. Delaney was convicted of one felony count under Federal law for conduct relating to the importation into the United States of an article of food. Mr. Delaney was given notice of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. As of August 10, 2012 (30 days after receipt of the notice), Mr. Delaney had not responded. Mr. Delaney's failure to respond constitutes a waiver of his right to a hearing concerning this action.

In accordance with section 10(a) of the Federal Advisory Committee Act, 5 U.S.C. App. 2, this notice announces a meeting of the National Advisory Council for Healthcare Research and Quality.

In accordance with the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, the Centers for Disease Control and Prevention (CDC) located within the Department of Health and Human Services (HHS) has reviewed the list of biological agents and toxins that have the potential to pose a severe threat to public health and safety and is republishing that list. As a result of our review, we have added Chapare virus, Lujo virus, and SARS-associated coronavirus (SARS-CoV) to the list of HHS select agents and toxins. We have also removed from the list of HHS and overlap select agents and toxins, or excluded from compliance with part 73, the agents and toxins described in the Executive Summary. Further, in accordance with Executive Order 13546, ``Optimizing the Security of Biological Select Agents and Toxins in the United States,'' HHS/CDC has designated those select agents and toxins that present the greatest risk of deliberate misuse with the most significant potential for mass casualties or devastating effects to the economy, critical infrastructure; or public confidence as ``Tier 1'' agents; established new security requirements for entities possessing Tier 1 agents, including the requirement to conduct pre- access assessments and on-going monitoring of personnel with access to Tier 1 agents and toxins; and made revisions to the regulations to clarify regulatory language concerning security, training, biosafety, and incident response. In a companion document published in this issue of the Federal Register, the United States Department of Agriculture (USDA) has made parallel regulatory changes.

This notice with comment period announces a hospital's request for a waiver from the requirement to have an agreement with its designated Organ Procurement Organization (OPO). The request was made in accordance with section 1138(a)(2) of the Social Security Act (the Act). In addition, this notice requests comments from OPOs and the general public for our consideration in determining whether we should grant the requested waiver.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) during August 2012 and to reflect a change of sponsor's address for Baxter Healthcare Corp. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable.

HHS gives notice concerning the final effect of the HHS decision to designate a class of employees from the Winchester Engineering and Analytical Center Site, in Winchester, Massachusetts, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On August 23, 2012, as provided for under 42 U.S.C. 7384q(b), the Secretary of HHS designated the following class of employees as an addition to the SEC:

HHS gives notice concerning the final effect of the HHS decision to designate a class of employees from the Clarksville Modification Center Site, Ft. Campbell, in Clarksville, Tennessee, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On August 23, 2012, as provided for under 42 U.S.C. 7384q(b), the Secretary of HHS designated the following class of employees as an addition to the SEC:

The Food and Drug Administration (FDA) is withdrawing approval of a new animal drug application (NADA) and three abbreviated new animal drug applications (ANADAs) at the sponsors' request because the products are no longer manufactured or marketed.

This document corrects technical errors in the final rule that appeared in the August 31, 2012 Federal Register entitled ``Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Fiscal Year 2013 Rates; Hospitals' Resident Caps for Graduate Medical Education Payment Purposes; Quality Reporting Requirements for Specific Providers and for Ambulatory Surgical Centers.''

The Food and Drug Administration's (FDA) Center for Drug Evaluation and Research/Office of Medical Policy and the Duke University Office of Continuing Medical Education are cosponsoring a 3- day training course for clinical investigators on scientific, ethical, and regulatory aspects of clinical trials. This training course is intended to provide clinical investigators with expertise in the design, conduct, and analysis of clinical trials; improve the quality of clinical trials; and enhance the safety of trial participants. Senior FDA staff will communicate directly with clinical investigators on issues of greatest importance for successful clinical research. Date and Time: The training course will be held on November 13 and 14, 2012, from 8 a.m. to 5 p.m., and on November 15, 2012, from 8 a.m. to 4 p.m. Location: The course will be held at the Holiday Inn College Park, 10000 Baltimore Ave., College Park, MD 20740. Contact Person: Connie Wisner, Office of Medical Policy, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 6360, Silver Spring, MD 20993, 301-796- 8509. Registration: Register by October 22, 2012. The registration fee is $400 per person. The fee includes course materials and onsite lunch. Early registration is recommended because seating is limited. There will be no onsite registration. Register online for the training course at the registration Web site: https://evm.auxserv.duke.edu/iebms/reg/regp1 form.aspx?oc=10&ct=DCRIINVEST&eventid=46475 or download a full-size copy of the registration form and mail a check and completed form to: Duke University Conference and Event Services, FDA Investigator Course Box 90841, 101 Bryan Center, Durham, NC 27708. You will receive an email that confirms your registration. (FDA has verified the Web site address, but FDA is not responsible for subsequent changes to the Web site after this document publishes in the Federal Register.) Attendees are responsible for their own accommodations. A block of rooms has been reserved under ``FDA Clinical Investigator Course'' at the Holiday Inn College Park at a reduced conference rate. Reservations for these accommodations can be made online using the course registration Web site mentioned previously. Click on ``registration form.'' You will see a direct link to the hotel. Registration materials, payment procedures, accommodation information, and a detailed description of the course can be found at the registration/information Web site mentioned previously. If you need special accommodations due to a disability, please contact Connie Wisner at least 7 days in advance. Persons attending the course are advised that FDA is not responsible for providing access to electrical outlets.

The Department of Health and Human Services (HHS) notifies Federal agencies of the Laboratories and Instrumented Initial Testing Facilities (IITF) currently certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first published in the Federal Register on April 11, 1988 (53 FR 11970), and subsequently revised in the Federal Register on June 9, 1994 (59 FR 29908); September 30, 1997 (62 FR 51118); April 13, 2004 (69 FR 19644); November 25, 2008 (73 FR 71858); December 10, 2008 (73 FR 75122); and on April 30, 2010 (75 FR 22809). A notice listing all currently certified Laboratories and Instrumented Initial Testing Facilities (IITF) is published in the Federal Register during the first week of each month. If any Laboratory/IITF's certification is suspended or revoked, the Laboratory/IITF will be omitted from subsequent lists until such time as it is restored to full certification under the Mandatory Guidelines. If any Laboratory/IITF has withdrawn from the HHS National Laboratory Certification Program (NLCP) during the past month, it will be listed at the end and will be omitted from the monthly listing thereafter. This notice is also available on the Internet at https:// www.workplace.samhsa.gov and https://www.drugfreeworkplace.gov.

The Food and Drug Administration (FDA or the Agency) is announcing the availability of a draft guidance for industry entitled ``Initial Completeness Assessments for Type II API DMFs Under GDUFA.'' Under the Generic Drug User Fee Amendments of 2012 (GDUFA), holders of certain drug master files, namely, Type II active pharmaceutical ingredient (API) drug master files (DMFs) that are referenced in generic drug applications, or in amendments or prior approval supplements to these applications, will be required to undergo an initial completeness assessment in accordance with FDA criteria. This guidance is intended to clarify the criteria FDA will use in the initial completeness assessment.

In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, which requires 60 days for public comment on proposed information collection projects, the Indian Health Service (IHS) is publishing for comment a summary of a proposed information collection to be submitted to the Office of Management and Budget (OMB) for review. Proposed Collection: Title: 0917-0030, ``IHS Forms to Implement the Privacy Rule (45 CFR Parts 160 & 164)''. Type of Information Collection Request: Extension, without revisions, of currently approved information collection, 0917-0030, ``IHS Forms to Implement the Privacy Rule (45 CFR Parts 160 & 164)''. Form Number(s): IHS-810, IHS-912-1, IHS-912-2, IHS-913 and IHS-917. Need and Use of Information Collection: This collection of information is made necessary by the Department of Health and Human Services Rule entitled ``Standards for Privacy of Individually Identifiable Health Information'' (Privacy Rule) (45 CFR parts 160 and 164). The Privacy Rule implements the privacy requirements of the Administrative Simplification subtitle of the Health Insurance Portability and Accountability Act of 1996, creates national standards to protect individual's personal health information, and gives patients increased access to their medical records. 45 CFR 164.508, 164.522, 164.526 and 164.528 of the Rule require the collection of information to implement these protection standards and access requirements. The IHS will continue to use the following data collection instruments to meet the information collection requirements contained in the Rule. 45 CFR 164.508: This provision requires covered entities to obtain or receive a valid authorization for its use or disclosure of protected health information for other than for treatment, payment and healthcare operations. Under the provision individuals may initiate a written authorization permitting covered entities to release their protected health information to entities of their choosing. The form IHS-810 ``Authorization for Use or Disclosure of Protected Health Information'' is used to document an individual's authorization to use or disclose their protected health information. 45 CFR 164.522: Section 164.522(a)(1) requires a covered entity to permit individuals to request that the covered entity restrict the use and disclosure of their protected health information. The covered entity may or may not agree to the restriction. The form IHS-912-1 ``Request for Restrictions(s)'' is used to document an individual's request for restriction of their protected health information, and whether IHS agreed or disagreed with the restriction. Section 164.522(a)(2) permits a covered entity to terminate its agreement to a restriction if the individual agrees to or requests the termination in writing. The form IHS-912-2 ``Request for Revocation of Restriction(s)'' is used to document the agency or individual request to terminate a formerly agreed to restriction regarding the use and disclosure of protected health information. 45 CFR 164.528 and 45 CFR 5b.9(c): This provision requires covered entities to permit individuals to request that the covered entity provide an accounting of disclosures of protected health information made by the covered entity. The form IHS-913 ``Request for an Accounting of Disclosures'' is used to document an individual's request for an accounting of disclosures of their protected health information and the agency's handling of the request. 45 CFR 164.526: This provision requires covered entities to permit an individual to request that the covered entity amend protected health information. If the covered entity accepts the requested amendment, in whole or in part, the covered entity must inform the individual that the amendment is accepted. If the covered entity denies the requested amendment, in whole or in part, the covered entity must provide the individual with a written denial. The form IHS-917 ``Request for Correction/Amendment of Protected Health Information'' will be used to document an individual's request to amend their protected health information and the agency's decision to accept or deny the request. Completed forms used in this collection of information are filed in the IHS medical, health and billing record, a Privacy Act System of Records Notice. Affected Public: Individuals and households. Type of Respondents: Individuals. Burden Hours: The table below provides the estimated burden hours for this information collection:

The Health Resources and Services Administration (HRSA)'s Bureau of Health Professions is issuing a non-competitive single source award to the Texas AHEC EastUniversity of Texas Medical Branch, an AHEC program grantee, to add a Behavioral Health component to a Community Health Worker (CHW) curriculum, pilot and evaluate it in primary care settings, and disseminate the curriculum. This project shall be titled: Community Health Worker (CHW) Behavioral Health Primary Care Integration Project. In fiscal year (FY) 2012, $486,394 will be available to fully fund this cooperative agreement with a single project/budget period of four years. The Texas AHEC East is uniquely qualified and has the capacity, capability, expertise, experience, and infrastructure to expeditiously, effectively, and efficiently implement the CHW Behavioral Health Primary Care Integration Project within their existing educational programming, and disseminate the tested model nationally. CHWs play an important role in increasing access to services for vulnerable populations, and increasing support for direct service workers, including community health workers, which is a priority for the Department of Health and Human Services as well as the Health Resources and Services Administration.

The Health Resources and Services Administration (HRSA)'s Bureau of Health Professions is issuing a non-competitive single source program expansion supplement award to the NEPQR Program grantee TAMUCC- CONHS to build upon their feasibility study, Transitioning Enlisted Health Care Training into Academic Credit for Nursing Education Programs, and undertake a dissemination program to advance the goal of aligning enlisted health care training with civilian nursing program requirements. In fiscal year (FY) 2012, $178,374 will be available to fund this award. TAMUCC-CONHS is uniquely qualified and has the capacity, capability, expertise, experience, and infrastructure to expeditiously, effectively, and efficiently implement the project within their existing educational programming. During the previous year, TAMUCC-CONHS has gained in-depth insight into the full range academic, financial, and socio-economic barriers that interfere with successful transition from military to civilian careers, and how these barriers are compounded by the burden of navigating the military- academic labyrinth. Thus they are well-positioned to bridge the gap between health care training command programs and academic programs in schools of nursing work.

The Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), is announcing a scientific public workshop to solicit information on a variety of issues related to the clinical development of disease-modifying agents for the treatment of peripheral neuropathy. Discussion will focus on possible therapeutic targets for these agents, the types of painful peripheral neuropathies amenable to treatment with disease-modifying agents, and clinical trial design. FDA intends to take this information into account in developing FDA guidance on clinical development programs for disease-modifying products for the management of peripheral neuropathy. Date and Time: The public workshop will be held on February 11, 2013, from 8:30 a.m. to 5 p.m. and February 12, 2013, from 8:30 a.m. to 2 p.m. Location: The public workshop will be held at FDA White Oak Campus, Building 31, The Great Room (Rm. 1503),White Oak Conference Center, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002. Entrance for the consultation meeting's participants (non-FDA employees) is through Building 1 where routine security check procedures will be performed. For parking and security information, please refer to https:// www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/ WhiteOakCampusInformation/ucm241740.htm Contacts:

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Acute Bacterial Exacerbations of Chronic Bronchitis in Patients With Chronic Obstructive Pulmonary Disease: Developing Antimicrobial Drugs for Treatment.'' This guidance addresses FDA's current thinking regarding the overall development program and clinical trial designs for drugs to support an indication for treatment of acute bacterial exacerbations of chronic bronchitis in patients with chronic obstructive pulmonary disease (ABECB-COPD), and finalizes the revised draft guidance issued on August 22, 2008.

This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National Institutes of Health (NIH), Department of Health and Human Services (HHS), is contemplating the grant of a worldwide exclusive evaluation option license, to practice the inventions embodied in: