Department of Health and Human Services April 1, 2013 – Federal Register Recent Federal Regulation Documents

Submission for OMB Review; 30-day Comment Request; The National Cancer Institute (NCI) SmokefreeTXT Program Evaluation
Document Number: 2013-07551
Type: Notice
Date: 2013-04-01
Agency: Department of Health and Human Services, National Institutes of Health
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 January 14, 2013 (Volume 78, Page 2678) and allowed 60-days for public comment. Shortly after the publication, two public comments were received requesting a copy of the data collection plans and instruments and one public comment was received in regards to the funding of the study. The comments were responded to with the requested information. 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. 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.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request
Document Number: 2013-07455
Type: Notice
Date: 2013-04-01
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the Health Resources and Services Administration (HRSA) will submit an Information Collection Request (ICR) to the Office of Management and Budget (OMB). Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period. To request a copy of the clearance requests submitted to OMB for review, email paperwork@hrsa.gov or call the HRSA Reports Clearance Office at (301) 443-1984. Information Collection Request Title: Bureau of Health Professions Performance Data Collection (OMB No. 0915-0061)[Revision]. Abstract: Over 40 BHPr programs award grants to health professions schools and training programs across the United States to develop, expand, and enhance training; and to strengthen the distribution of the health workforce. Many of these programs are governed by the Public Health Service Act (42 U.S.C. 201 et seq.), specifically Titles III, VII, and VIII. Performance information is collected in the HRSA Performance Report for Grants and Cooperative Agreements (PRGCA). Data collection activities at application, progress, and annual performance satisfy statutory and programmatic requirements for performance measurement and evaluation (including specific Title III, VII and VIII requirements), as well as Government Performance and Results Act (GPRA) requirements. The Affordable Care Act (Pub. L. 111- 148) impacted a broad range of health workforce programs administered by BHPr. It reauthorized most of these programs and, in some cases, expanded eligibility, modified program activities, and/or established new requirements. The Affordable Care Act also created new health professions programs. Therefore, it was necessary to reexamine BHPr's existing performance measures to ensure that they address these changes, meet evolving program management needs, and respond to emerging workforce concerns. The proposed revised data collection will enhance analysis and reporting of grantee training and education activities, outcomes, and intended practice locations. Data collected from these grant programs will also provide a description of the program activities of more than 1,600 reporting grantees to better inform policymakers on the barriers, opportunities, and outcomes involved in health care workforce development. The proposed measures focus on five key outcomes: (1) Increasing the workforce supply of diverse well-educated practitioners; (2) influencing the distribution of practitioners to practice in underserved and rural areas; (3) enhancing the quality of education; (4) diversifying the pipeline for new health professionals; and (5) supporting educational infrastructure to increase the capacity to train more health professionals. Revisions to the current reporting will require the collection of baseline data at the grant application and award stages and will include performance reporting semi-annually by the type of programs: direct financial support programs, infrastructure programs, and multipurpose or hybrid programs (could be direct financial support, infrastructure or both within the same grant program). Measures will be reported at the individual, program-specific and/or program cluster-levels. Burden Statement: Burden in this context means the time expended by persons to generate, maintain, retain, disclose or provide the information requested. This includes the time needed to review instructions, to develop, acquire, install and utilize technology and systems for the purpose of collecting, validating and verifying information, processing and maintaining information, and disclosing and providing information, to train personnel and to be able to respond to a collection of information, to search data sources, to complete and review the collection of information, and to transmit or otherwise disclose the information. The total annual burden hours estimated for this ICR are summarized in the table below. The annual estimate of burden is as follows:
Current List of Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal Agencies
Document Number: 2013-07446
Type: Notice
Date: 2013-04-01
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
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 http:// www.workplace.samhsa.gov and http://www.drugfreeworkplace.gov.
Draft Guidance for Industry on Formal Meetings Between FDA and Biosimilar Biological Product Sponsors or Applicants; Availability
Document Number: 2013-07445
Type: Notice
Date: 2013-04-01
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Formal Meetings Between the FDA and Biosimilar Biological Product Sponsors or Applicants.'' This draft guidance provides recommendations to industry on formal meetings between FDA and sponsors or applicants relating to the development and review of biosimilar biological products regulated by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). The guidance assists sponsors and applicants in generating and submitting a meeting request and the associated meeting package to FDA for biosimilar biological products.
Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial Review
Document Number: 2013-07444
Type: Notice
Date: 2013-04-01
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial Review
Document Number: 2013-07443
Type: Notice
Date: 2013-04-01
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial Review
Document Number: 2013-07442
Type: Notice
Date: 2013-04-01
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial Review
Document Number: 2013-07441
Type: Notice
Date: 2013-04-01
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial Review
Document Number: 2013-07440
Type: Notice
Date: 2013-04-01
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial Review
Document Number: 2013-07439
Type: Notice
Date: 2013-04-01
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Disease, Disability, and Injury Prevention and Control Special Emphasis Panels (SEP): Initial Review
Document Number: 2013-07438
Type: Notice
Date: 2013-04-01
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Draft Guidance for Industry on Scale-Up and Post-Approval Changes: Manufacturing Equipment Addendum; Availability
Document Number: 2013-07432
Type: Notice
Date: 2013-04-01
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a scale-up and post-approval changes (SUPAC) draft guidance for industry entitled ``SUPAC: Manufacturing Equipment Addendum.'' This revised draft document combines and supersedes ``SUPAC IR/MR: Immediate Release and Modified Release Solid Oral Dosage Forms: Manufacturing Equipment Addendum,'' published on January 1, 1999; and ``SUPAC-SS: Nonsterile Semisolid Dosage Forms; Manufacturing Equipment Addendum,'' published as a draft on December 1, 1998. FDA has now revised the draft manufacturing equipment addenda to remove the equipment examples and to clarify the types of processes being referenced.
National Institute of Neurological Disorders and Stroke; Notice of Closed Meetings
Document Number: 2013-07425
Type: Notice
Date: 2013-04-01
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meeting
Document Number: 2013-07424
Type: Notice
Date: 2013-04-01
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meeting
Document Number: 2013-07423
Type: Notice
Date: 2013-04-01
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meeting
Document Number: 2013-07422
Type: Notice
Date: 2013-04-01
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Complementary and Alternative Medicine; Notice of Meeting
Document Number: 2013-07421
Type: Notice
Date: 2013-04-01
Agency: Department of Health and Human Services, National Institutes of Health
Request for Information: The National Toxicology Program Requests Information On Assays and Approaches Useful for Screening Compounds for Potential Neurotoxicity
Document Number: 2013-07420
Type: Notice
Date: 2013-04-01
Agency: Department of Health and Human Services, National Institutes of Health
The National Toxicology Program (NTP) requests information on medium- or high-throughput technologies/assay systems, which allow for the batch screening of compounds (e.g., 25-50) in biochemical- or cell- based assays or alternative (non-rodent) animal models, that might be used to prioritize compounds for in vivo neurotoxicity testing.
Center for Scientific Review; Notice of Meeting
Document Number: 2013-07419
Type: Notice
Date: 2013-04-01
Agency: Department of Health and Human Services, National Institutes of Health
Listing of Color Additives Exempt From Certification; Reactive Blue 246 and Reactive Blue 247 Copolymers
Document Number: 2013-07294
Type: Rule
Date: 2013-04-01
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is amending the color additive regulations to provide for the safe use of additional copolymers of 1,4-bis[4-(2-methacryloxyethyl)phenylamino]anthraquinone (C.I. Reactive Blue 246) and copolymers of 1,4-bis[(2- hydroxyethyl)amino]-9,10-anthracenedione bis(2-methyl-2-propenoic)ester (C.I. Reactive Blue 247) as color additives in contact lenses. This action is in response to two color additive petitions (CAPs) filed by CooperVision, Inc.
Walking as a Way for Americans To Get the Recommended Amount of Physical Activity for Health
Document Number: 2013-07204
Type: Notice
Date: 2013-04-01
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
To address the public health problem of physical inactivity, the Centers for Disease Control and Prevention (CDC), within the Department of Health and Human Services (HHS) announces the opening of a docket to obtain information from the public on walking as an effective way to be sufficiently active for health. The information obtained will be used to frame an anticpated Surgeon General's call to action on this issue.