Department of Health and Human Services 2015 – Federal Register Recent Federal Regulation Documents

The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, 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. This notice invites comment on the FoodNet Population Survey which is a telephone-based survey to gather information to estimate the total number of acute diarrheal illnesses in the U.S. and assess the frequency of exposures commonly associated with foodborne illness.

The Food and Drug Administration (FDA or we) is amending the food additive regulations by removing the upper bound of the melting point range in the regulation for the antioxidant tertiary butylhydroquinone (TBHQ) and adding a purity acceptance criterion. This action is in response to a petition submitted by Eastman Chemical Company.

In compliance with section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, has submitted an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB) for review and approval. The ICR is for a new collection. 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.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Food Allergen Labeling and Reporting'' 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 it has received a petition requesting exemption from the premarket notification requirements for an electric positioning chair with a motorized positioning control that is intended for medical purposes and that can be adjusted to various positions. The device is used to provide stability for patients with athetosis (involuntary spasms) and to alter postural positions. FDA is publishing this notice to obtain comments in accordance with procedures established by the Food and Drug Administration Modernization Act of 1997 (FDAMA).

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Assessment of Male-Mediated Developmental Risk for Pharmaceuticals.'' This draft guidance provides recommendations to sponsors for assessing risks to embryo/fetal development resulting from administration of an active pharmaceutical ingredient (API) to males either through an effect on the male germ cell or from fetal exposure following seminal transfer of a potentially developmental toxicant to pregnant females. The need for measures to mitigate the risk to embryo/fetal development posed by males participating in clinical trials is also addressed.

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 Department of Health and Human Services, Administration for Children and Families, Office of Community Services (OCS) will host a virtual Tribal Consultation to consult on the Assets for Independence (AFI) program proposed Performance Progress Report (PPR).

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a document entitled ``Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products; Guidance for Industry.'' The guidance document is to assist sponsors and investigators in designing early-phase clinical trials for cellular therapy (CT) and gene therapy (GT) products (referred to collectively as CGT products). The guidance document provides recommendations regarding clinical trials in which the primary objectives are the initial assessments of safety, tolerability, or feasibility of administration of investigational products. The guidance announced in this notice finalizes the draft guidance of the same title dated July 2013.

In accordance with the Awarding Agency Grants Administration Manual (AAGAM) Chapter 2.04.103, the Bureau of Primary Health Care (BPHC) has been granted a class deviation from the exceptions to maximum competition requirements contained in the AAGAM Chapter 2.04.104A-5 to provide additional funding without competition to the 37 Health Center Controlled Networks (HCCNs) awarded under announcement HRSA-13-237, extending their December 1, 2014, to November 31, 2015, budget period through July 31, 2016. This action will align the project period end dates of all active HCCN grants and ensure maximum competition for a single HCCN funding opportunity in fiscal year (FY) 2016.

In accordance with the Privacy Act of 1974 (5 U.S.C. 522a), as amended, OCSE is publishing notice of a computer matching program between OCSE and state agencies administering the Unemployment Compensation program.

The Administration for Children and Families (ACF), Office of Community Services (OCS), Division of Energy Assistance (DEA) announces the estimated median income of four-person households in each state, the District of Columbia, and Puerto Rico for FFY 2016 (October 1, 2015, to September 30, 2016).

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 Library of Medicine (NLM), 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. This summary describes the existing information collection at ClinicalTrials.gov, for which an extension is requested; it does not include any changes to the information collection that were proposed in the Notice of Proposed Rulemaking on Clinical Trial Registration and Results Submission that was issued on November 21, 2014 (79 FR 225, Nov. 21, 2014). Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. To Submit Comments and For Further Information: To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: David Sharlip, Office of Administrative and Management Analysis Services, National Library of Medicine, Building 38A, Room B2N12, 8600 Rockville Pike, Bethesda, MD 20894, or call non-toll-free number (301) 402-9680, or Email your request, including your address to: sharlipd@mail.nih.gov Formal requests for additional plans and instruments must be requested in writing. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication. Proposed Collection: Information Program on Clinical Trials: Maintaining a Registry and Results Databank (NLM), 0925-0586, Expiration Date: 08/31/2015, EXTENSION, National Library of Medicine (NLM), National Institutes of Health (NIH). Need and Use of Information Collection: The National Institutes of Health operates ClinicalTrials.gov, which was established as a clinical trial registry under section 113 of the Food and Drug Administration Modernization Act of 1997 (Pub. L. 105-115) and was expanded to include a results data bank by Title VIII of the Food and Drug Administration Amendments Act of 2007 (FDAAA). ClinicalTrials.gov collects registration and results information for clinical trials and other types of clinical studies (e.g., observational studies and patient registries) with the objectives of enhancing patient enrollment and providing a mechanism for tracking subsequent progress of clinical studies, to the benefit of public health. It is widely used by patients, physicians, and medical researchers; in particular those involved in clinical research. While many clinical studies are registered and submit results information voluntarily, FDAAA requires the registration of certain applicable clinical trials of drugs and devices and the submission of results information for completed applicable clinical trials of drugs and devices that are approved, licensed, or cleared by the Food and Drug Administration. Beginning in 2009, results information was required to include information about serious and frequent adverse events. This extension request does not include any changes to the information submission requirements for ClinicalTrials.gov that were proposed in the Notice of Proposed Rulemaking on Clinical Trial Registration and Results Submission that was issued on November 21, 2014 and for which the public comment period closed on March 23, 2015 (79 FR 225, Nov. 21, 2014). The NIH is continuing to review submitted public comments as it prepares the final rule. The NIH will make any corresponding changes to the ClinicalTrials.gov information collection via separate procedure. OMB approval is requested for 3 years. The total estimated annualized cost to respondents is $49,399,851. The total estimated annualized burden hours are 682,535.

The Food and Drug Administration (FDA) has determined that Ondansetron (ondansetron hydrochloride (HCl)) Injection, USP in PL 2408 Plastic Container, 32 milligrams (mg) in 50 milliliters (mL), single intravenous (IV) dose, was withdrawn from sale for reasons of safety or effectiveness. The Agency will not accept or approve abbreviated new drug applications (ANDAs) for Ondansetron (ondansetron HCl) Injection, USP in PL 2408 Plastic Container, 32 mg/50 mL, single IV dose.

The Food and Drug Administration (FDA) is extending the comment period for the notice of public hearing that appeared in the Federal Register of March 27, 2015. In the notice of public hearing, FDA requested comments on a number of specific questions identified in the document. The Agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.

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 or Agency) is announcing the availability of a draft guidance for industry entitled ``Duchenne Muscular Dystrophy and Related Dystrophinopathies: Developing Drugs for Treatment.'' The purpose of this draft guidance is to assist sponsors in the clinical development of drugs for the treatment of X-linked Duchenne muscular dystrophy (DMD) and related dystrophinopathies.

Pursuant to the NIH Reform Act of 2006 (42 U.S.C. Sec.281 (d)(4)), notice is hereby given that the National Institute on Drug Abuse (NIDA) will provide two opportunities to enable public discussion on the Institute's proposal to reorganize its extramural program.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled, ``Prominent and Conspicuous Mark of Manufacturers on Single-Use Devices'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

Federal statute and regulation require each Protection and Advocacy (P&A) System to prepare and submit to HHS a Statement of Goals and Priorities (SGP) for the P&A for Developmental Disabilities (PADD) program for each coming fiscal year. While the P&A is mandated to protect and advocate under a range of different Federally authorized disabilities programs, only the PADD program requires an SGP. Following the required public input for the coming fiscal year, the P&As submit the final version of this SGP to the Administration on Intellectual and Developmental Disabilities (AIDD). AIDD will analyze each SGP for compliance and aggregate the information in the SGPs into a national profile of programmatic emphasis for P&A Systems in the coming year. This aggregation will provide AIDD with a tool for monitoring of the P&As, including the public input requirement. Furthermore, it will provide an overview of program priorities, and permit AIDD to track accomplishments against goals, permitting the formulation of technical assistance and compliance with the Developmental Disabilities Assistance and Bill of Rights Act of 2000.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Risk and Benefit Perception Scale Development'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

In compliance with section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, has submitted an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB) for review and approval. The ICR is for a new collection. 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.

This document further informs the public of ONC's policy that permits any person or entity to submit test procedures, test tools, and test data for approval and use under the ONC Health IT Certification Program.

HHS gives notice of a decision to designate a class of employees from the Dow Chemical Company in Pittsburg, California, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000.

On April 6, 2015, the Administrator of the World Trade Center (WTC) Health Program received a petition (Petition 007) to add certain autoimmune diseases, including rheumatoid arthritis and connective tissues diseases, to the List of WTC-Related Health Conditions (List). Upon reviewing the scientific and medical literature, including information provided by the petitioner, the Administrator has determined that the available evidence does not have the potential to provide a basis for a decision on whether to add certain autoimmune diseases to the List. The Administrator finds that insufficient evidence exists to request a recommendation of the WTC Health Program Scientific/Technical Advisory Committee (STAC), to publish a proposed rule, or to publish a determination not to publish a proposed rule.

The Food and Drug Administration (FDA) is issuing a final order to reclassify nonroller-type cardiopulmonary bypass blood pump (NRP) devices for cardiopulmonary and circulatory bypass, a preamendments class III device, into class II (special controls), and to require the filing of a premarket approval application (PMA) for NRP devices for temporary ventricular support. FDA is also revising the title and identification of the regulation for NRP devices in this order.

The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, 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. This notice invites comment on the proposed revision of the National Quitline Data Warehouse (NQDW) information collection. The NQDW is a repository of information about callers who have received services from state quitlines and a quarterly summary of services provided by each quitline.

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. Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.

The National Cancer Institute's (NCI) Division of Cancer Control and Population Sciences (DCCPS) announces that they are partnering with Sage Bionetworks to launch ``Up For A Challenge (U4C) Stimulating Innovation in Breast Cancer Genetic Epidemiology'' (the ``Challenge'') to encourage unique approaches to more fully decipher the genomic basis of breast cancer. Utilizing innovative approaches, the goal of this Challenge is to identify new genes or combinations of genes, genetic variants, or sets of genomic features involved in breast cancer susceptibility. In addition, the NCI aims to advance innovation in the field of genetic epidemiology by making data more widely available, increasing the amount and diversity of minds approaching a difficult scientific problem, and promoting broader collaborations. This Challenge is being launched under the America COMPETES Reauthorization Act of 2010.

The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, 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. This notice invites comment on a proposed reinstatement of an information collection entitled ``Interventions to Reduce Shoulder MSDs in Overhead Assembly''. This information collection is part of a study to assess the effectiveness and cost- benefit of occupational safety and health (OSH) interventions to prevent musculoskeletal disorders (MSDs) among workers in the Manufacturing (MNF) sector.

The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (the PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry on the Voluntary Qualified Importer Program (VQIP) for importers of human or animal food. The draft guidance describes VQIP, which provides for expedited review and importation of food offered for importation by importers who voluntarily agree to participate in the program. The draft guidance describes the eligibility criteria for, and benefits of, participation in VQIP. The draft guidance also provides information on submitting an application for VQIP participation, obtaining a facility certification for the foreign supplier of a food imported under VQIP, the VQIP user fee, conditions that might result in the revocation of VQIP eligibility, and criteria for reinstatement of eligibility. We are issuing the draft guidance in accordance with the Federal Food, Drug, and Cosmetic Act (FD&C Act).

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Current Good Manufacturing Practices for Finished Pharmaceuticals'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

Under the National Childhood Vaccine Injury Act (NCVIA) (42 U.S.C. 300aa-26), the CDC must develop vaccine information materials that all health care providers are required to give to patients/parents prior to administration of specific vaccines. On June 25, 2014, CDC published a notice in the Federal Register (79 FR 36068) seeking public comments on proposed new vaccine information materials for Td, Tdap, Haemophilus influenzae type b (Hib), and rotavirus vaccines. Following review of comments submitted and consultation as required under the law, CDC has finalized the materials. Copies of the final vaccine information materials for Td, Tdap, Hib, and rotavirus are available to download from https://www.cdc.gov/vaccines/hcp/vis/ or https:// www.regulations.gov (see Docket Number CDC-2014-0007).

The meeting announced in this notice concerns Natural Experiments of the Impact of Population-targeted Health Policies to Prevent Diabetes and its Complications, DP15-001, initial review. In accordance with Section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), the Centers for Disease Control and Prevention (CDC) announces the aforementioned meeting:

In accordance with Section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), the Centers for Disease Control and Prevention (CDC) announces a meeting for the initial review of applications in response to Funding Opportunity Announcement (FOA), RFA-EH-15-001, Environmental Health Specialists Network (EH-Net) Practice based research to improve food safety.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled, ``Disclosure Regarding Additional Risks in Direct-to-Consumer Prescription Drug Television Advertisements'' 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 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 issuing this notice to request that public stakeholders, including patient and consumer advocacy groups, health care professionals, and scientific and academic experts, notify FDA of their intent to participate in periodic consultation meetings on the reauthorization of the Generic Drug User Fee Amendments of 2012 (GDUFA). The statutory authority for GDUFA expires at the end of September 2017. At that time, new legislation will be required for FDA to continue collecting user fees for the generic drug program. The Federal Food, Drug, and Cosmetic Act (the FD&C Act) requires that FDA consult with a range of stakeholders in developing recommendations for the next GDUFA program. The FD&C Act also requires that FDA hold continued discussions with patient and consumer advocacy groups at least monthly during FDA's negotiations with the regulated industry. The purpose of this request for notification is to ensure continuity and progress in these monthly discussions by establishing consistent stakeholder representation.

The Health Resources and Services Administration (HRSA) is issuing a limited competition for awards among the 40 current Graduate Psychology Education (GPE) Program grantees whose project periods end June 30, 2016. No more than $1,000,000 will be made available in federal fiscal year (FY) 2015 in the form of 1-year project period grants. These awards are specifically for interprofessional training of doctoral psychology graduate students and interns to address the psychological needs of military personnel, veterans, and their families in civilian and community-based settings, including those in rural areas. An estimated five grants will be awarded with a ceiling amount of $190,000 per grant for 1 year. These funds will be used to establish, expand, and/or enhance activities that were funded under the FY 2013 GPE Program. Program funds are to be used for stipend support for interns and doctoral students, faculty development, curriculum and instructional design, program content enhancement, program infrastructure development, and the supervision and training support of interns.

The Food and Drug Administration (FDA or we) is confirming the effective date of April 21, 2015, for the final rule that appeared in the Federal Register of March 20, 2015, and that amended the color additive regulations to expand the permitted uses of synthetic iron oxide as a color additive to include use in soft and hard candy, mints, and chewing gum.

The Food and Drug Administration (FDA) is amending its animal drug regulations regarding veterinary feed directive (VFD) drugs. FDA's current VFD regulation established requirements relating to the distribution and use of VFD drugs and animal feeds containing such drugs. This amendment is intended to improve the efficiency of FDA's VFD program while protecting human and animal health.

The Administration for Community Living (ACL) was created in order to achieve several important objectives: to reduce the fragmentation that currently exists in federal programs addressing the community living service and support needs of both the aging and disability populations; to enhance access to quality health care and long-term services and supports for older adults and people with disabilities; to promote consistency in community living policy across other areas of the federal government; and to complement the community infrastructure, as supported by both Medicaid and other federal programs, in order to better respond to the full spectrum of needs of seniors and persons with disabilities. Public Law 113-128, the Workforce Innovation and Opportunity Act (WIOA), furthers these objectives by transferring three groups of programsthe Independent Living (IL) Programs, the National Institute on Disability and Rehabilitation Research (now titled the National Institute on Disability, Independent Living, and Rehabilitation Research), and the Assistive Technology (AT) Act programsfrom the Department of Education's Office of Special Education and Rehabilitative Services (OSERS) to the HHS Administration for Community Living (ACL). This reorganization incorporates these programs into ACL's structure with the IL programs and the AT Act section 5 programs included under the newly established Administration on Disabilities; the National Institute on Disability, Independent Living, and Rehabilitation Research (NIDILRR) reporting directly to the ACL Administrator; and the AT Act section 4 programs located in the Office of Consumer Access and Self-Determination within the renamed Center for Integrated Programs (formally the Center for Consumer Access and Self-Determination).

Under the provisions of section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institute of Environmental Health Sciences (NIEHS), the National Institutes of Health, has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on March 16, 2015, Volume 80, Number 50, page 13562 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 National Institute of Environmental Health Sciences (NIEHS), 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. Direct Comments to OMB: 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: Office of Management and Budget, Office of Regulatory Affairs, OIRA_submission@omb.eop.gov or by fax to 202-395-6974, Attention: NIH Desk Officer. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30 days of the date of this publication. For Further Information: To obtain a copy of the data collection plans and instruments, or request more information on the proposed project, contact: Dr. Kristianna Pettibone, Evaluator, Program Analysis Branch, NIEHS, NIH, 530 Davis Dr., Room 3055, Morrisville, NC 20560, or call non-toll-free number 919-541-7752 or Email your request, including your address to: pettibonekg@niehs.nih.gov. Formal requests for additional plans and instruments must be requested in writing. PROPOSED COLLECTION DERT Extramural Grantee Data Collection, 0925- 0657, Expiration Date 06/30/2015REVISION, National Institute of Environmental Health Sciences (NIEHS), National Institutes of Health (NIH). Need and Use of Information Collection: In order to make informed management decisions about its research programs and to demonstrate the outputs, outcomes and impacts of its research programs NIEHS will collect, analyze and report on data from extramural grantees who are currently receiving funding or who have received funding in the past on topics such as: (1) Key scientific outcomes achieved through the research and the impact on the field of environmental health science; (2) Contribution of research findings to program goals and objectives; (3) Satisfaction with the program support received; (4) Challenges and benefits of the funding mechanism used to support the science; and (5) Emerging research areas and gaps in the research. Information gained from this primary data collection will be used in conjunction with data from grantee progress reports and presentations at grantee meetings to inform internal programs and new funding initiatives. Outcome information to be collected includes measures of agency-funded research resulting in dissemination of findings, investigator career development, grant-funded knowledge and products, commercial products and drugs, laws, regulations and standards, guidelines and recommendations, information on patents and new drug applications and community outreach and public awareness relevant to extramural research funding and emerging areas of research. Satisfaction information to be collected includes measures of satisfaction with the type of funding or program management mechanism used, challenges and benefits with the program support received, and gaps in the research. Frequency of Response: Once per grantee, per research portfolio. Affected Public: Current or past grantees from: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); National Institute on Deafness and Other Communication Disorders (NIDCD); National Institute of Mental Health (NIMH); National Institute of Neurological Disorders and Stroke (NINDS); National Institute of Environmental Health Sciences (NIEHS); and National Cancer Institute (NCI). OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 700.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Prescription Drug Marketing Act of 1987; Policies, Requirements, and Administrative Procedures'' 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 amending its regulations to clarify that the Agency will provide an opportunity for an informal hearing in connection with a proposed rule to ban a device with a special effective date. This action is being taken to align the regulations with the Federal Food, Drug, and Cosmetic Act (the FD&C Act).

The U.S. Department of Health and Human Services (HHS) intends to hold a prize competition in which up to $20 million will be made available, subject to the availability of funds, for the delivery of one or more successful rapid point-of-care diagnostics that may be used by health care providers to identify bacterial infections. The National Institutes of Health (NIH) and the Biomedical Advanced Research and Development Authority (BARDA) are sponsoring the prize competition, and seek public comments regarding the technical criteria and performance characteristics of the diagnostic(s) for which the prize(s) will be offered.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry (GFI) #232 entitled ``Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: General Approach to Establish an Acute Reference Dose (ARfD)'' (VICH GL54). This draft guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This draft VICH guidance document is intended to address the nature and types of data that can be useful in determining an ARfD for residues of veterinary drugs, the studies that may generate such data, and how the ARfD may be calculated based on these data.

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.