Request for Nominations for Voting Members on a Public Advisory Committee; Science Board to the Food and Drug Administration, 3609-3610 [2015-01114]

Download as PDF 3609 Federal Register / Vol. 80, No. 15 / Friday, January 23, 2015 / Notices Section 760(e) (21 U.S.C. 379aa(e) of the FD&C Act also requires that responsible persons maintain records of nonprescription adverse event reports, whether or not the event is serious, for a period of 6 years. The guidance document recommends that respondents maintain records of efforts to obtain the minimum data elements for a report of a serious adverse drug event and any follow-up reports. We estimate that there are approximately 20,000 records per year maintained by approximately 200 respondents, and that it takes approximately 5 hours to maintain each record. TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 Activity Number of recordkeepers Number of records per recordkeeper Total annual records Average burden per recordkeeping Total hours Recordkeeping (21 U.S.C. 379aa(e)(1)) .............................. 200 100 20,000 5 100,000 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Therefore, the estimated annual reporting burden for this information is 25,000 hours and the estimated annual recordkeeping burden is 100,000 hours. Dated: January 15, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–01111 Filed 1–22–15; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2015–N–0001] Request for Nominations for Voting Members on a Public Advisory Committee; Science Board to the Food and Drug Administration AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is requesting nominations for members to serve on the Science Board to the Food and Drug Administration, Office of the Commissioner, Office of the Chief Scientist. FDA seeks to include the views of women and men, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees and, therefore, encourages nominations of appropriately qualified candidates from these groups. DATES: Nominations received on or before March 24, 2015 will be given first consideration for membership on the Science Board to the Food and Drug Administration. Nominations received after March 24, 2015 will be considered for nomination to the committee as later vacancies occur. ADDRESSES: All nominations for membership should be sent electronically by logging into the FDA Advisory Nomination Portal: https:// tkelley on DSK3SPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 18:05 Jan 22, 2015 Jkt 235001 www.accessdata.fda.gov/scripts/ FACTRSPortal/FACTRS/index.cfm or by mail to Advisory Committee Oversight and Management Staff, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5103, Silver Spring, MD 20993–0002. FOR FURTHER INFORMATION CONTACT: Regarding all nomination questions for membership, the primary contact is: Martha Monser, Office of the Chief Scientist, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 3309, Silver Spring, MD 20993–0002, 301–796–4627, martha.monser@fda.hhs.gov. Information about becoming a member on an FDA advisory committee can also be obtained by visiting FDA’s Web site by using the following link: https://www.fda.gov/ AdvisoryCommittees/default.htm. SUPPLEMENTARY INFORMATION: FDA is requesting nomination for voting members on the Science Board to the Food and Drug Administration. I. General Description of the Committee Duties The Science Board shall provide advice to the Commissioner and other appropriate officials on specific complex scientific and technical issues important to FDA and its mission, including emerging issues within the scientific community. Additionally, the Science Board will provide advice that supports the Agency in keeping pace with technical and scientific developments, including in regulatory science, provide input into the Agency’s research agenda, and on upgrading its scientific and research facilities and training opportunities. It will also provide, where requested, expert review of Agency sponsored intramural and extramural scientific research programs. II. Criteria for Voting Members The committee consists of a core of 21 voting members including the chair and a co-chair. Members, the chair and the PO 00000 Frm 00063 Fmt 4703 Sfmt 4703 co-chair are selected by the Commissioner or designee from among authorities knowledgeable in the fields of: Food science, safety, and nutrition; chemistry, pharmacology, translational and clinical medicine and research, toxicology, biostatistics, medical devices, imaging, robotics, cell and tissue based products, regenerative medicine, public health and epidemiology, international health and regulation, product safety, product manufacturing sciences and quality; and other scientific areas relevant to FDA regulated products such as systems biology, informatics, nanotechnology, and combination products. Almost all non-Federal members of this committee serve as Special Government Employees. Members will be invited to serve for terms of up to 4 years. III. Nomination Procedures Any interested person may nominate one or more qualified individuals for membership on the advisory committee. Self-nominations are also accepted. Nominations must include a current, complete resume or curriculum vitae for each nominee, including current business address and/or home address, telephone number, and email address if available. Nominations must also specify the advisory committee for which the nominee recommended. Nominations must also acknowledge that the nominee is aware of the nomination unless self-nominated. FDA will ask potential candidates to provide detailed information concerning such matters related to financial holdings, employment, and research grants and/or contracts to permit evaluation of possible sources of conflicts of interest. This notice is issued under the Federal Advisory Committee Act (5 U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees. E:\FR\FM\23JAN1.SGM 23JAN1 3610 Federal Register / Vol. 80, No. 15 / Friday, January 23, 2015 / Notices Dated: January 15, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–01114 Filed 1–22–15; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Statement of Organization, Functions and Delegations of Authority This notice amends Part R of the Statement of Organization, Functions and Delegations of Authority of the Department of Health and Human Services (HHS), Health Resources and Services Administration (HRSA) (60 FR 56605, as amended November 6, 1995; as last amended at 79 FR 75164–75165 dated December 17, 2014). This notice reflects organizational changes in the Health Resources and Services Administration (HRSA), Healthcare Systems Bureau (HSB). Specifically, this notice: (1) Updates the functional statement for the Division of National Hansen’s Disease Programs (RRH). Chapter RR—Healthcare Systems Bureau tkelley on DSK3SPTVN1PROD with NOTICES Section RR–20, Functions Delete the functional statement for the Division of National Hansen’s Disease Programs (RRH) in its entirety and replace with the following: Division of National Hansen’s Disease Programs (RRH) The National Hansen’s Disease Programs (NHDP) in accordance with regulations of the Public Health Service (PHS) Act, Sec. 320 as amended by Sec. 211, PL105–78); (1) provides care and treatment for persons with Hansen’s Disease (leprosy), including managing a national short-term and outpatient health care delivery program providing specialized services to persons with Hansen’s Disease; (2) conducts and promotes the coordination of research (including clinical research), investigations, demonstrations, and studies relating to the causes, diagnosis, treatment, control, and prevention of Hansen’s disease and other 18:05 Jan 22, 2015 Jkt 235001 Section RR–30, Delegations of Authority All delegations of authority and redelegations of authority made to HRSA officials that were in effect immediately prior to this reorganization, and that are consistent with this reorganization, shall continue in effect pending further re-delegation. This reorganization is effective upon date of signature. Dated: January 16, 2015. Mary K. Wakefield, Administrator. [FR Doc. 2015–01131 Filed 1–22–15; 8:45 am] Section RR—00, Mission The Healthcare Systems Bureau (HSB) protects the public health and improves the health of individuals through an array of programs that provide national leadership and direction in targeted areas. VerDate Sep<11>2014 mycobacterial diseases and complications related to such diseases; (3) conducts training in the diagnosis and management of Hansen’s disease and related complications; (4) provides education and training to staff from the outpatient Hansen’s Disease Clinics and private physicians; (5) operates and oversees the National Hansen’s Disease Museum and Cemetery; (6) consults on the coordination of activities within HRSA and HHS, and with other federal agencies, state and local governments, and other public and private organizations involved in Hansen’s Disease activities; and (7) manages a network of outpatient clinics through contracts providing care to persons with Hansen’s Disease. BILLING CODE 4165–15–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute of Allergy and Infectious Diseases Special Emphasis Panel; NIAID Investigator Initiated Program Project Application (P01). Date: February 19, 2015. Time: 11:00 a.m. to 2:00 p.m. PO 00000 Frm 00064 Fmt 4703 Sfmt 4703 Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 5601 Fishers Lane, Rockville, MD 20892 (Telephone Conference Call). Contact Person: Eleazar Cohen, Ph.D., Scientific Review Officer, Scientific Review Program, Division of Extramural Activities, National Institutes of Health, NIAID, 5601 Fishers Lane, Rockville, MD 20892, 240–669– 5881, ec17w@nih.gov. Name of Committee: National Institute of Allergy and Infectious Diseases Special Emphasis Panel; NIAID Investigator Initiated Program Project Applications (P01). Date: February 23, 2015. Time: 12:00 p.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Room 3F100, 5601 Fishers Lane, Rockville, MD 20892 (Telephone Conference Call). Contact Person: Quirijn Vos, Ph.D., Scientific Review Officer, Scientific Review Program, Division of Extramural Activities, DHHS/NIH/NIAID, 5601 Fishers Lane, Rockville, MD 20892, 240–669–5059, qvos@ niaid.nih.gov. Name of Committee: National Institute of Allergy and Infectious Diseases Special Emphasis Panel; NIAID Investigator Initiated Program Project Applications (P01). Date: February 26, 2015. Time: 11:00 a.m. to 2:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 5601 Fishers Lane, Rockville, MD 20892 (Telephone Conference Call). Contact Person: Eleazar Cohen, Ph.D., Scientific Review Officer, Scientific Review Program, Division of Extramural Activities, National Institutes of Health, NIAID, 5601 Fishers Lane, Rockville, MD 20892, 240–669– 5881, ec17w@nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.855, Allergy, Immunology, and Transplantation Research; 93.856, Microbiology and Infectious Diseases Research, National Institutes of Health, HHS) Dated: January 16, 2015. David Clary, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2015–01087 Filed 1–22–15; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the E:\FR\FM\23JAN1.SGM 23JAN1

Agencies

[Federal Register Volume 80, Number 15 (Friday, January 23, 2015)]
[Notices]
[Pages 3609-3610]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-01114]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-0001]


Request for Nominations for Voting Members on a Public Advisory 
Committee; Science Board to the Food and Drug Administration

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is requesting 
nominations for members to serve on the Science Board to the Food and 
Drug Administration, Office of the Commissioner, Office of the Chief 
Scientist. FDA seeks to include the views of women and men, members of 
all racial and ethnic groups, and individuals with and without 
disabilities on its advisory committees and, therefore, encourages 
nominations of appropriately qualified candidates from these groups.

DATES: Nominations received on or before March 24, 2015 will be given 
first consideration for membership on the Science Board to the Food and 
Drug Administration. Nominations received after March 24, 2015 will be 
considered for nomination to the committee as later vacancies occur.

ADDRESSES: All nominations for membership should be sent electronically 
by logging into the FDA Advisory Nomination Portal: https://www.accessdata.fda.gov/scripts/FACTRSPortal/FACTRS/index.cfm or by mail 
to Advisory Committee Oversight and Management Staff, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5103, Silver 
Spring, MD 20993-0002.

FOR FURTHER INFORMATION CONTACT: Regarding all nomination questions for 
membership, the primary contact is: Martha Monser, Office of the Chief 
Scientist, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 1, Rm. 3309, Silver Spring, MD 20993-0002, 301-796-4627, 
martha.monser@fda.hhs.gov.
    Information about becoming a member on an FDA advisory committee 
can also be obtained by visiting FDA's Web site by using the following 
link: https://www.fda.gov/AdvisoryCommittees/default.htm.

SUPPLEMENTARY INFORMATION: FDA is requesting nomination for voting 
members on the Science Board to the Food and Drug Administration.

I. General Description of the Committee Duties

    The Science Board shall provide advice to the Commissioner and 
other appropriate officials on specific complex scientific and 
technical issues important to FDA and its mission, including emerging 
issues within the scientific community. Additionally, the Science Board 
will provide advice that supports the Agency in keeping pace with 
technical and scientific developments, including in regulatory science, 
provide input into the Agency's research agenda, and on upgrading its 
scientific and research facilities and training opportunities. It will 
also provide, where requested, expert review of Agency sponsored 
intramural and extramural scientific research programs.

II. Criteria for Voting Members

    The committee consists of a core of 21 voting members including the 
chair and a co-chair. Members, the chair and the co-chair are selected 
by the Commissioner or designee from among authorities knowledgeable in 
the fields of: Food science, safety, and nutrition; chemistry, 
pharmacology, translational and clinical medicine and research, 
toxicology, biostatistics, medical devices, imaging, robotics, cell and 
tissue based products, regenerative medicine, public health and 
epidemiology, international health and regulation, product safety, 
product manufacturing sciences and quality; and other scientific areas 
relevant to FDA regulated products such as systems biology, 
informatics, nanotechnology, and combination products. Almost all non-
Federal members of this committee serve as Special Government 
Employees. Members will be invited to serve for terms of up to 4 years.

III. Nomination Procedures

    Any interested person may nominate one or more qualified 
individuals for membership on the advisory committee. Self-nominations 
are also accepted. Nominations must include a current, complete resume 
or curriculum vitae for each nominee, including current business 
address and/or home address, telephone number, and email address if 
available. Nominations must also specify the advisory committee for 
which the nominee recommended. Nominations must also acknowledge that 
the nominee is aware of the nomination unless self-nominated. FDA will 
ask potential candidates to provide detailed information concerning 
such matters related to financial holdings, employment, and research 
grants and/or contracts to permit evaluation of possible sources of 
conflicts of interest.
    This notice is issued under the Federal Advisory Committee Act (5 
U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees.


[[Page 3610]]


    Dated: January 15, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-01114 Filed 1-22-15; 8:45 am]
BILLING CODE 4164-01-P
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