Department of Health and Human Services 2011 – Federal Register Recent Federal Regulation Documents

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``Evaluation of ARRA Comparative Effectiveness Research Dissemination Contractor Efforts.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously published in the Federal Register on July 27th, 2011 and allowed 60 days for public comment. No comments were received. The purpose of this notice is to allow an additional 30 days for public comment.

HHS gives notice of a determination concerning a petition to add a class of employees from the Piqua Organic Moderated Reactor, Piqua, Ohio, to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000 (EEOICPA), 42 U.S.C. 7384q. On October 26, 2011, the Secretary of HHS determined that the following class of employees does not meet the statutory criteria for addition to the SEC as authorized under EEOICPA:

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Investigational Device Exemptions (IDE) for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies.'' Through the approaches announced in this draft guidance, FDA intends to facilitate early feasibility studies of medical devices, using appropriate risk mitigation strategies, under the IDE requirements. Early feasibility studies allow for limited early clinical evaluations of devices to provide proof of principle and initial clinical safety data before the device design is finalized. This draft guidance addresses the information that should be provided to FDA in support of an early feasibility study IDE application and explains the requirements applicable to modifications to the device design or clinical protocol during the early feasibility study. This draft guidance is not final nor is it in effect at this time.

Statement of Organizations, Functions, and Delegations of Authority. The Administration for Children and Families has reorganized the Office of Refugee Resettlement. This reorganization includes the organization and its substructure components as listed in this document. This reorganization establishes the Division of Refugee Health. It renames the Division of Community Resettlement to the Division of Refugee Services. It renames the Division of Unaccompanied Children's Services to the Division of Children's Services. It deletes the Division of Budget, Policy, and Data Analysis and moves the function to the Office of the Director. The notice also serves to establish an Associate Deputy Director position.

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 (insert name of NIH Institute or Center), the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Proposed Collection: Title: Application for collaboration with the NIH Center for Translational Therapeutics (NCTT). Type of Information Collection Request: NEW. Need and Use of Information Collection: Programs at the NCTT provide opportunities to partner with and gain access to both common and specifically rare and neglected disease through a variety of programs delivering assay development, screening, hit to lead chemistry, lead optimization, chemical biology studies, drug development capabilities, expertise, and clinical/regulatory resources in a collaborative environment with the goal of moving promising therapeutics into human clinical trials. NCTT uses an application and evaluation process to select collaborators. Selected investigators provide the drug project starting points and ongoing biological/disease expertise throughout the project. Frequency of Response: Four per year. Affected Public: Research scientists. Type of Respondents: Academic scientists, industry, not-for-profits, government organizations, patient groups. The annual reporting burden is as follows: Estimated Number of Respondents: 170. Estimated Number of Responses per Respondent: 1. Average Burden Hours Per Response: 4. Estimated Total Annual Burden Hours Requested: 680.

This final rule amends the Head Start Program regulations to implement statutory provisions of the Improving Head Start for School Readiness Act of 2007 to establish a system of designation renewal to determine if Head Start and Early Head Start agencies are delivering high-quality and comprehensive Head Start and Early Head Start programs that meet the educational, health, nutritional, and social needs of the children and families they serve and meet program and financial management requirements and standards. This system of designation renewal will determine which grantees must compete for on-going funding. This final rule is consistent with Executive Order 13563 and in particular its requirement, in section 6, of ``periodic review of existing significant regulations.''

The Food and Drug Administration (FDA) is reopening until November 28, 2011, the comment period for the notice entitled ``Draft Guidance for Industry and Food and Drug Administration Staff; 510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device; Availability,'' that appeared in the Federal Register of July 27, 2011 (76 FR 44935). In that document, FDA announced the availability of a draft guidance for industry and FDA staff and requested comments. The Agency is taking this action to allow interested persons additional time to submit comments.

The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Guidance for Industry: Clinical Considerations for Therapeutic Cancer Vaccines'' dated October 2011. The guidance document provides sponsors who wish to submit an Investigational New Drug application (IND) for a therapeutic cancer vaccine with recommendations on critical clinical considerations for investigational studies of these products. The guidance also provides recommendations for the design of clinical trials for cancer vaccines conducted under an IND to support a subsequent biologics license application (BLA) for marketing approval. The guidance applies to therapeutic cancer vaccines that are intended for the treatment of patients with an existing diagnosis of cancer. The guidance does not apply to vaccines for preventative and therapeutic infectious disease indications, to products intended to induce or augment a non-specific immune response, or to products intended to prevent or decrease the incidence of cancer in individuals without a prior history of that cancer. Furthermore, the guidance does not apply to adoptive immunotherapeutic products which may mediate their therapeutic effect by targeting the tumor directly, such as T cell or NK cell products. The guidance announced in this notice finalizes the draft guidance of the same title dated September 2009.

The Food and Drug Administration (FDA) is proposing to classify in vitro diagnostic devices for Yersinia species (spp.) detection into class II (special controls), in accordance with the recommendation of the Microbiology Devices Advisory Panel (the panel). FDA is publishing in this document the recommendation(s) of the panel regarding the classification of this device. After considering public comments on the proposed classification, FDA will publish a final regulation classifying this device.

This notice requests comments on proposed eligibility criteria for the Centers of Excellence (COE) program in health professions education for under-represented minority (URM) individuals (See Title VII, Section 736 of the Public Health Service Act, 42 U.S.C. 293 (2011) as amended by the Patient Protection and Affordable Care Act, Public Law 111-148, Sec. 5401 (2010)). When finalized, these eligibility criteria will be used to determine the eligibility of designated health professions schools to apply for COE funding in fiscal year (FY) 2012 and subsequent fiscal years. Funding is dependent on the availability of appropriated funds for the COE program. The designated health professions schools are schools of allopathic medicine, osteopathic medicine, dentistry, pharmacy, and graduate programs in behavioral or mental health. This does not apply to Historically Black Colleges and Universities (HBCUs) eligible to establish a COE, under PHS Act section 736(c)(2).

Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case: Jayant Jagannathan, M.D., University of Virginia Medical Center: Based on the report of an investigation conducted by the University of Virginia (UVA) and additional analysis conducted by ORI in its oversight review, ORI found that Dr. Jayant Jagannathan, former Resident Physician at UVA Medical Center, engaged in research misconduct by plagiarizing research supported by National Institutes of Health (NIH) research and training awards and by NIH intramural research funds from the National Institute of Neurological Disorders and Stroke (NINDS), Surgical Neurosurgery Branch (NSB), and from the National Institute of Dental and Craniofacial Research (NIDCR). ORI found that the Respondent engaged in research misconduct by including, in five publications, large amounts of text and an illustration that he plagiarized from publications supported by the following NIH grant awards: T32 CA09677, P01 HL024136, R01 HL059157, P50 CA090270, M01 RR01346, R01 CA075979, R01 DK064169, R01 NS027544, R01 NS052406, and K08 NS002197,\1\ and by intramural funds from the Surgical Neurosurgery Branch, NINDS, and from NIDCR.

As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Service (DHHS) is hereby giving notice that the Presidential Advisory Council on HIV/AIDS (PACHA) will hold a meeting. The meeting will be conducted as a telephone conference call. The meeting will be open to the public through a conference call phone number.

HHS gives notice of a decision to designate a class of employees from Vitro Manufacturing in Canonsburg, Pennsylvania, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On October 18, 2011, the Secretary of HHS designated the following class of employees as an addition to the SEC:

HHS gives notice of a decision to designate a class of employees from W.R. Grace and Company in Curtis Bay, Maryland, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On October 18, 2011, the Secretary of HHS designated the following class of employees as an addition to the SEC:

This final rule sets forth updates to the home health prospective payment system (HH PPS) rates, including: the national standardized 60-day episode rates; the national per-visit rates; and the low utilization payment amount (LUPA) under the Medicare PPS for home health agencies effective January 1, 2012. This rule applies a 1.4 percent update factor to the episode rates, which reflects a 1 percent reduction applied to the 2.4 percent market basket update factor, as mandated by the Affordable Care Act. This rule also updates the wage index used under the HH PPS, and further reduces home health payments to account for continued nominal growth in case-mix which is unrelated to changes in patient health status. This rule removes two hypertension codes from the HH PPS case-mix system, thereby requiring recalibration of the case-mix weights. In addition, the rule implements two structural changes designed to decrease incentives to upcode and provide unneeded therapy services. Finally, this rule incorporates additional flexibility regarding face-to-face encounters with providers related to home health care.

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 Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (CERCLA or Superfund), as amended by the Superfund Amendments and Reauthorization Act of 1986 (SARA), requires that ATSDR and the Environmental Protection Agency (EPA) prepare a Priority List of Hazardous Substances commonly found at facilities on the CERCLA National Priorities List (NPL). The Priority List of Hazardous Substances includes substances that have been determined to be of greatest public health concern to persons at or near NPL sites. CERCLA as amended also requires that the Priority List of Hazardous Substances be revised periodically. This announcement provides notice that a revised Priority List of 275 Hazardous Substances has been developed and is now available for download. CERCLA as amended also requires ATSDR to prepare and to periodically revise toxicological profiles on hazardous substances included in the priority list. Thus, each priority list substance is a potential toxicological profile subject, as well as a candidate for identification of priority data needs. In addition to the Priority List of Hazardous Substances, ATSDR has developed a Completed Exposure Pathway Site Count Report. This report lists the number of sites or events at which ATSDR is involved and wherein a substance has been found in a completed exposure pathway (CEP).

This notice advises the public of the published lists of all geographic areas, population groups, and facilities designated as primary medical care, mental health, and dental health professional shortage areas (HPSAs) as of September 1, 2011, available on the Health Resources and Services Administration (HRSA) Web site at https:// bhpr.hrsa.gov/shortage/. HPSAs are designated or withdrawn by the Secretary of Health and Human Services (HHS) under the authority of section 332 of the Public Health Service (PHS) Act and 42 CFR part 5.

In accordance with Section 10(a) of the Federal Advisory Committee Act, Public Law 92-463, as amended (5 U.S.C. App.), notice is hereby given that a Web meeting is scheduled to be held for the Advisory Group on Prevention, Health Promotion, and Integrative and Public Health (the ``Advisory Group''). The Web meeting will be open to the public. Information about the Advisory Group and the agenda for this meeting can be obtained by accessing the following Web site: https://www.healthcare.gov/prevention/nphpphc/advisorygrp/inde x.html

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``MEPS Cancer Self Administrated Questionnaire.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection.

The Food and Drug Administration (FDA) is announcing the availability of a revised guidance for industry (100) entitled ``Impurities: Residual Solvents in New Veterinary Medicinal Products, Active Substances and Excipients (Revision)'' VICH GL18(R). This revised guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). The guidance is intended to recommend acceptable amounts of residual solvents in new animal drugs (referred to as pharmaceuticals or veterinary medicinal products in this guidance) for the safety of the target animal as well as for the safety of human consumers of products derived from treated food producing animals. It is intended to assist in developing new animal drug applications (referred to as marketing applications in this guidance) submitted to the European Union, Japan, and the United States.

The Ryan White HIV/AIDS Treatment Extension Act of 2009 (Pub. L. 111-87) addresses notification procedures for medical facilities and state public health officers and their designated officers regarding exposure of emergency response employees (EREs) to potentially life- threatening infectious diseases. The Secretary of Health and Human Services (Secretary) has delegated authority to the Director of the Centers for Disease Control and Prevention (CDC) to issue a list of potentially life-threatening infectious diseases, including emerging infectious diseases, to which EREs may be exposed in responding to emergencies (including a specification of those infectious diseases that are routinely transmitted through airborne or aerosolized means); guidelines describing circumstances in which employees may be exposed to these diseases; and guidelines describing the manner in which medical facilities should make determinations about exposures. On December 13, 2010, CDC invited comment on a draft list of covered infectious diseases and both sets of guidelines (75 FR 77642). In consideration of the comments received, this notice sets forth CDC's final list of diseases, final guidelines describing circumstances under which exposure to listed diseases may occur, and final guidelines for determining whether an exposure to the listed diseases has occurred.

This interim final rule with comment period establishes waivers of the application of the Physician Self-Referral Law, the Federal anti-kickback statute, and certain civil monetary penalties (CMP) law provisions to specified arrangements involving accountable care organizations (ACOs) under section 1899 of the Social Security Act (the Act) (the Shared Savings Program), including ACOs participating in the Advance Payment Initiative. Section 1899(f) of the Act, as added by the Affordable Care Act, authorizes the Secretary to waive certain fraud and abuse laws as necessary to carry out the provisions of section 1899 of the Act.

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 Food and Drug Administration (FDA) is announcing a public meeting entitled ``Cosmetic Microbiological Safety Issues.'' The purpose of the public meeting is to provide stakeholders an opportunity to present information regarding cosmetic microbiological safety and to suggest areas for the possible development of FDA guidance documents. FDA is seeking information regarding microbiological testing of cosmetics; types of preservative systems and how to test their efficacy; the identity and prevalence of microorganisms, including antibiotic-resistant strains, that pose specific health risks in finished products; routes of exposure to microorganisms and the corresponding infective doses; product and packaging characteristics that affect microbial growth and risk of infection; particular subpopulations that may be at greater risk of infection when using different cosmetic products; the occurrence of adverse events associated with microbial contamination of cosmetics; and any other issues relevant to the microbiological safety of cosmetics.

The Food and Drug Administration (FDA) is requesting that any industry organization interested in participating in the selection of nonvoting industry representatives to serve on the National Mammography Quality Assurance Advisory Committee (NMQAAC) in the Center for Devices and Radiological Health 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 current vacancies effective with this notice.

This annual notice announces Medicare's Hospital Insurance (Part A) premium for uninsured enrollees in calendar year (CY) 2012. This premium is paid by enrollees age 65 and over who are not otherwise eligible for benefits under Medicare Part A (hereafter known as the ``uninsured aged'') and by certain disabled individuals who have exhausted other entitlement. The monthly Part A premium for the 12 months beginning January 1, 2012, for these individuals will be $451. The reduced premium for certain other individuals as described in this notice will be $248.

This notice announces the monthly actuarial rates for aged (age 65 and over) and disabled (under age 65) beneficiaries enrolled in Part B of the Medicare Supplementary Medical Insurance (SMI) program beginning January 1, 2012. In addition, this notice announces the monthly premium for aged and disabled beneficiaries as well as the income-related monthly adjustment amounts to be paid by beneficiaries with modified adjusted gross income above certain threshold amounts. The monthly actuarial rates for 2012 are $199.80 for aged enrollees and $192.50 for disabled enrollees. The standard monthly Part B premium rate for 2012 is $99.90, which is equal to 50 percent of the monthly actuarial rate for aged enrollees or approximately 25 percent of the expected average total cost of Part B coverage for aged enrollees. (The 2011 standard premium rate was $115.40) The Part B deductible for 2012 is $140.00 for all Part B beneficiaries. If a beneficiary has to pay an income-related monthly adjustment, they may have to pay a total monthly premium of about 35, 50, 65, or 80 percent of the total cost of Part B coverage.

The Administration for Children and Families (ACF), Office of Administration (OA), Office of Information Services (OIS) announces the award of $1,000,000 as a single-source expansion supplement grant to extend an award made to the Johns Hopkins University (JHU), Greenberg School of Public Health in Baltimore, MD. The grant will allow JHU, and its partner, JHU Applied Physics Laboratory, to continue the development of a Human Services National Interoperable Architecture (HSNIA). Under the supplement award, JHU and its partners will develop Phase III of an architectural framework that will be used as a model to facilitate State and local agencies in information exchanges among eligibility and verification services that are developed by the HHS/ Centers for Medicare and Medicaid Services (CMS) under the requirements of the Patient Protection and Affordable Care Act (ACA). To address issues related to implementation of the ACA and the Improper Payments Elimination and Recovery Act of 2010, the Administration has directed Federal Agencies to begin to design and execute plans related to the legislation. JHU and its partners will create the development of a conceptual information technology architecture with ACF/Office of Information Services. The project will produce a solution that supports information exchanges and interoperability that will lead to reductions in improper payments as a preventative step in the program integrity process.

This notice announces that the Administration for Children and Families (ACF), Administration on Developmental Disabilities (ADD) has awarded a single-source program expansion supplement grant of $159,679 for post-secondary education opportunities. The Institute for Community Inclusion at the University of Massachusetts in collaboration with seven ACF-ADD supported University Centers for Excellence in Developmental Disabilities Education, Research, and Service (UCEDDs) in Delaware, Minnesota, Hawaii, South Carolina, Tennessee [Vanderbilt], Ohio, and California along with the Association of University Centers on Disabilities (AUCD) has established a consortium that will conduct research, provide training and technical assistance, and disseminate information on promising practices that support individuals with developmental disabilities to increase their independence, productivity, and inclusion through access to post-secondary education. Think College's goals are to improve long- term independent living and employment outcomes for individuals with developmental disabilities. The consortium is acting as a national resource for knowledge, training, materials, and dissemination of information on participation in post-secondary education of individuals with developmental disabilities.

The Administration for Children and Families (ACF), Administration on Developmental Disabilities (ADD), Office of Program Support (OPS) announces the award of a single-source grant of $620,000 to the National Association of Councils on Developmental Disabilities (NACDD), located in Washington, DC. The award will support a project to provide training and technical assistance (T/TA) to the designated State Councils on Developmental Disabilities (State Councils). The primary focus of the T/TA is to improve program performance, statutory compliance, and program outcomes across the network of State Councils. Toward this end, NACDD shall provide T/TA to the entities designated by ADD as State Councils. Under this project, it is expected that initiatives shall be identified and undertaken to support the improvement of State Council operations and performance.

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 an exclusive worldwide license to practice the invention embodied in: HHS Ref. No. E-175-1995/0 and/1;

The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of October 25, 2011 (76 FR 66074). The document announced the availability of a guidance for industry entitled ``Required Warnings for Cigarette Packages and AdvertisementsSmall Entity Compliance Guide'' for a final rule that published in the Federal Register of June 22, 2011 (76 FR 36628). The notice published with an incorrect docket number. This document corrects that error.

The Administration on Children, Youth and Families, Family and Youth Services Bureau (FYSB), announces the award of a single-source program expansion supplement grant of $311,997 to the National Runaway Switchboard (NRS) in Chicago, IL, for initiatives in the areas of quality assurance, comprehensive outreach and increased capacity through technology improvements. Through these initiatives, NRS will improve its outreach to youth through Web site enhancements such as, increased access to the ``Live Chat'' function; recruitment of additional Spanish-English bilingual volunteers; increased outreach and partnerships with local, regional and national organizations to enhance NRS' national impact in crisis intervention for youth and families. In terms of evidence-based programming, this funding will also enable NRS to conduct a study and evaluate efforts in the area of reconnecting runaway youth with their families.

The Food and Drug Administration (FDA) and the Food Safety Inspection Service (FSIS) are correcting a notice that appeared in the Federal Register of September 15, 2011 (76 FR 57050). In that notice, FDA and FSIS established dockets to obtain comments, data, and evidence relevant to the dietary intake of sodium, as well as current and emerging approaches designed to promote sodium reduction. The document published with two typographical errors in the References section. This document corrects those errors.

This proposed notice with comment period acknowledges the receipt of a deeming application from the American Association for Accreditation of Ambulatory Surgery Facilities (AAAASF) for recognition as a national accrediting organization for rural health clinics (RHCs) that wish to participate in the Medicare or Medicaid programs. The statute requires that within 60 days of receipt of an organization's complete application, we publish a notice that identifies the national accrediting body making the request, describes the nature of the request, and provides at least a 30-day public comment period.

The Alliance for Nanotechnology in Cancer of the National Cancer Institute (NCI) is initiating a public private industry partnership called TONIC (Translation Of Nanotechnology In Cancer) to promote translational research and development opportunities of nanotechnology-based cancer solutions. An immediate consequence of this effort will be the formation of a consortium involving government and pharmaceutical, and biotechnology companies. This consortium will evaluate promising nanotechnology platforms and facilitate their successful translation from academic research to clinical environment, resulting in safe, timely, effective and novel diagnosis and treatment options for cancer patients. The purpose of this notice is to inform the community about the Alliance for Nanotechnology in Cancer of NCI's intention to form the consortium and to invite eligible companies (as defined in last paragraph) to participate.

The Presidential Commission for the Study of Bioethical Issues will conduct its seventh meeting in November. At this meeting, the Commission will continue discussing the current Federal standards regarding human subjects protection in scientific studies supported by the Federal government. The Commission will also develop and finalize recommendations regarding actions the Federal government should take to ensure that the health and well-being of participants in scientific studies supported by the Federal government are protected.

The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

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 August 17, 2011, pages 51042-51043, and allowed 60 days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The NIH may not conduct or sponsor, and the respondent is not required to respond to, information that has been extended, revised or implemented on or after October 1, 2008, unless it displays a currently valid OMB control number. Proposed Collection: Title: National Institutes of Health Construction GrantsB42 CFR part 52b (Final Rule). Type of Information Collection Request: Extension of No. 0925-0424, expiration date 8/31/ 2008. Need and Use of the Information Collection: This request is for OMB review and approval of an extension for the information collection and recordkeeping requirements contained in the regulation codified at 42 CFR part 52b. The purpose of the regulation is to govern the awarding and administration of grants awarded by NIH and its components for construction of new buildings and the alteration, renovation, remodeling, improvement, expansion, and repair of existing buildings, including the provision of equipment necessary to make the buildings (or applicable part of the buildings) suitable for the purpose for which it was constructed. In terms of reporting requirements: Section 52b.9(b) of the regulation requires the transferor of a facility which is sold or transferred, or owner of a facility, the use of which has changed, to provide written notice of the sale, transfer or change within 30 days. Section 52b.10(f) requires a grantee to submit an approved copy of the construction schedule prior to the start of construction. Section 52b.10(g) requires a grantee to provide daily construction logs and monthly status reports upon request at the job site. Section 52b.11(b) requires applicants for a project involving the acquisition of existing facilities to provide the estimated cost of the project, cost of the acquisition of existing facilities, and cost of remodeling, renovating, or altering facilities to serve the purposes for which they are acquired. In terms of recordkeeping requirements: Section 52b.10(g) requires grantees to maintain daily construction logs and monthly status reports at the job site. Frequency of Response: On occasion. Affected Public: Non-profit organizations and Federal agencies. Type of respondents: Grantees. The estimated respondent burden is as follows:

Under the provisions of Section (3507(a)(1)(D)) of the Paperwork Reduction Act of 1995, the National Institutes of Health 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 May 2, 2011, pages 24497-24498, and allowed 60 days for public comment. Two written comments and two verbal comments were received. The verbal comments expressed support for the broad scope of the study. The written comments were identical and questioned the cost and utility of the study. 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. Proposed Collection: Title: Neuro-developmental and Psycho-Social Measures Formative Research Studies for the National Children's Study (NCS). Type of Information Request: New. Need and Use of Information Collection: The Children's Health Act of 2000 (Pub. L. 106-310) states: (a) Purpose.It is the purpose of this section to authorize the National Institute of Child Health and Human Development* to conduct a national longitudinal study of environmental influences (including physical, chemical, biological, and psychosocial) on children's health and development. (b) In General.The Director of the National Institute of Child Health and Human Development* shall establish a consortium of representatives from appropriate Federal agencies (including the Centers for Disease Control and Prevention, the Environmental Protection Agency) to (1) Plan, develop, and implement a prospective cohort study, from birth to adulthood, to evaluate the effects of both chronic and intermittent exposures on child health and human development; and (2) investigate basic mechanisms of developmental disorders and environmental factors, both risk and protective, that influence health and developmental processes. (c) Requirement.The study under subsection (b) shall (1) Incorporate behavioral, emotional, educational, and contextual consequences to enable a complete assessment of the physical, chemical, biological, and psychosocial environmental influences on children's well-being; (2) gather data on environmental influences and outcomes on diverse populations of children, which may include the consideration of prenatal exposures; and (3) consider health disparities among children, which may include the consideration of prenatal exposures. To fulfill the requirements of the Children's Health Act, the results of formative research will be used to maximize the efficiency (measured by scientific robustness, participant and infrastructure burden, and cost) of tools to assess language, behavior, and neurodevelopment, psychosocial stress, and health literacy and thereby inform data collection methodologies for the National Children's Study (NCS) Vanguard and Main Studies. With this submission, the NCS seeks to obtain OMB's generic clearance to conduct formative research featuring neuro-developmental and psycho-social measures. The results from these formative research projects will inform the feasibility (scientific robustness), acceptability (burden to participants and study logistics) and cost of NCS Vanguard and Main Study neuro-developmental and psycho-social measures in a manner that minimizes public information collection burden compared to burden anticipated if these projects were incorporated directly into either the NCS Vanguard or Main Study. Frequency of Response: Annual [As needed on an on-going and concurrent basis]. Affected Public: Members of the public, researchers, practitioners, and other health professionals. Type of Respondents: Women of child-bearing age, infants, children, fathers, community leaders, members, and organizations, health care facilities and professionals, public health, environmental, social and cognitive science professional organizations and practitioners, hospital administrators, cultural and faith-based centers, and schools and child care organizations. These include both persons enrolled in the NCS Vanguard Study and their peers who are not participating in the NCS Vanguard Study. Annual reporting burden: See Table 1. The annualized cost to respondents is estimated at: $540,000 (based on $10 per hour). There are no Capital Costs to report. There are no Operating or Maintenance Costs to report.

The National Institute on Deafness and Other Communication Disorders (NIDCD), National Institutes of Health (NIH) is requesting public comment on the draft 2012-2016 NIDCD Strategic Plan. The NIDCD supports and conducts research and research training in the areas of hearing and balance; smell and taste; and voice, speech, and language. The Strategic Plan serves as a guide to the NIDCD in prioritizing its research investment, illustrates the current state-of-the-science, and highlights recent advances in the communication sciences. The draft Plan presents a series of goals and objectives that represent the most promising research needs within the NIDCD's mission areas. The draft Plan is available for download at: https://www.nidcd.nih.gov/about/ plans/strategic/pages/publiccomments.aspx.

October 31, 2011 marks the national release of the Healthy People 2020 leading health indicators (LHIs). The LHIs were developed to communicate high-priority health issues to the public, and actions that can be taken to address them. The Office of Disease Prevention and Health Promotion, in partnership with Health 2.0 and the Office of the National Coordinator of Health IT, is launching an LHI App Challenge to encourage teams of developers and health professionals to build an application that addresses one or more LHI topics on a community level. The overall purpose of the Challenge is to provide public health practitioners, business, elected officials, clinicians and the public with applications to help achieve national priority health goals.

The Food and Drug Administration (FDA) is announcing a review of the ``Bar Code Final Rule,'' under Executive Order 13563, ``Improving Regulation and Regulatory Review.'' The Bar Code Final Rule, which was published in 2004, requires certain human drug products and biological products to have a bar code. Information submitted can help FDA to reassess the costs and benefits of the rule and to identify any relevant changes in technology that have occurred since it went into effect. FDA is establishing a public docket to receive information relevant to reassessing the Bar Code Rule. This is an opportunity for interested persons to share information, research, and ideas on the need, maturity, and acceptability of alternative identification technologies for the identification, including the unique identification, of drugs and biological products. FDA will use the information received to assess whether the Bar Code Final Rule is achieving its intended benefits as effectively as possible or should be modified.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Channels of Trade Policy for Commodities With Residues of Pesticide Chemicals'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``What You Need to Know About Administrative Detention of Foods.'' This guidance provides information pertaining to FDA's authority to order the administrative detention of food for human or animal consumption under the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the FDA Food Safety and Modernization Act (FSMA).

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Temporary Marketing Permit Applications'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Request for Designation as Country Not Subject to the Restrictions Applicable to Human Food and Cosmetics Manufactured From, Processed With, or Otherwise Containing, Material From Cattle'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Guidance for Industry: Implementation of Acceptable Abbreviated Donor History Questionnaire and Accompanying Materials for Use in Screening Frequent Donors of Blood and Blood Components'' dated October 2011. The draft guidance document recognizes the abbreviated donor history questionnaire and accompanying materials (aDHQ documents), version 1.3 dated August 2011, as an acceptable mechanism for collecting blood donor history information from frequent donors of blood and blood components that is consistent with FDA's requirements and recommendations for collecting donor history information. The aDHQ documents will provide blood establishments that collect blood and blood components with a specific process for administering questions to frequent donors of blood and blood components to determine their eligibility to donate.