Request for Nominations for Voting Members on a Public Advisory Committee; Pharmacy Compounding Advisory Committee, 2179-2180 [2014-00318]

Download as PDF 2179 Federal Register / Vol. 79, No. 8 / Monday, January 13, 2014 / Notices TABLE 1—COMMITTEE DESCRIPTION, TYPE OF CONSUMER REPRESENTATIVE VACANCY, AND APPROXIMATE DATE NEEDED Committee areas of expertise needed Current vacancies Pharmacy Compounding—Knowledgeable in the fields of pharmaceutical compounding; pharmaceutical manufacturing; pharmacy, medicine, and related specialties. 1—Voting ................................................. I. Pharmacy Compounding Drugs Advisory Committee The Committee provides advice on scientific, technical, and medical issues concerning drug compounding under sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353a and 353b), and, as required, any other product for which FDA has regulatory responsibility, and makes appropriate recommendations to the Commissioner of Food and Drugs. tkelley on DSK3SPTVN1PROD with NOTICES II. Criteria for Members Persons nominated for membership as consumer representatives on committees should meet the following criteria: (1) Demonstrate ties to consumer- and community-based organizations; (2) be able to analyze technical data; (3) understand research design; (4) be able to discuss benefits and risks; and (5) be able to evaluate the safety and efficacy of products under review. The consumer representative should be able to represent the consumer perspective on issues and actions before the advisory committee; serve as a liaison between the committee and interested consumers, associations, coalitions, and consumer organizations; and facilitate dialogue with the advisory committees on scientific issues that affect consumers. III. Selection Procedures Selection of members representing consumer interests is conducted through procedures that include the use of organizations representing the public interest and consumer advocacy groups. These organizations recommend nominees for the Agency’s selection. Representatives from the consumer health branches of Federal, State, and local governments may also participate in the selection process. Any consumer organization interested in participating in the selection of an appropriate voting member to represent consumer interests should send a letter stating that interest to FDA (see ADDRESSES) within 30 days of publication of this document. Within the subsequent 30 days, FDA will compile a list of consumer organizations that will participate in the selection process and will forward to each such organization a ballot listing at least two qualified nominees selected by VerDate Mar<15>2010 16:40 Jan 10, 2014 Jkt 232001 the Agency based on the nominations received, along with each nominee’s ´ ´ current curriculum vitae or resume. Ballots are to be filled out and returned to FDA within 30 days. The nominee receiving the highest number of votes ordinarily will be selected to serve as the member representing consumer interests for that particular advisory committee. IV. Nomination Procedures Any interested person or organization may nominate one or more qualified persons to represent consumer interests on the Agency’s advisory committees. Self-nominations are also accepted. Nominations should include a cover ´ ´ letter and a current, complete resume or curriculum vitae for each nominee, including a current business address and/or home address, telephone number, email address if available, and a list of consumer- or community-based organizations for which the candidate can demonstrate active participation. Nominations also should specify the advisory committee for which the nominee is recommended. In addition, nominations should include confirmation that the nominee is aware of the nomination, is willing to serve as a member of the advisory committee if selected, and appears to have no conflict of interest. FDA will ask potential candidates to provide detailed information concerning such matters as financial holdings, employment, and research grants and/or contracts in order to permit evaluation of possible sources of conflicts of interest. Members will be invited to serve for terms of up to 4 years. FDA will review all nominations received within the specified timeframes and prepare a ballot containing the names of qualified nominees. Names not selected will remain on a list of eligible nominees and will be reviewed periodically by FDA to determine continued interest. Upon selecting qualified nominees for the ballot, FDA will provide those consumer organizations that are participating in the selection process with the opportunity to vote on the listed nominees. Only organizations vote in the selection process. Persons who nominate themselves to serve as PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 Approximate date needed Immediately. voting consumer representatives will not participate in the selection process. Elsewhere in this issue of the Federal Register, FDA is publishing a notice requesting nominations for voting members of the Committee, a notice for industry organizations to participate in the nominations for and selection of the industry representatives for the Committee, and a final rule updating information regarding the Committee. 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. Dated: January 7, 2014. Jill Hartzler Warner, Acting Associate Commissioner for Special Medical Programs. [FR Doc. 2014–00319 Filed 1–10–14; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–N–0001] Request for Nominations for Voting Members on a Public Advisory Committee; Pharmacy Compounding Advisory Committee AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is requesting nominations for 12 voting members to serve on the Pharmacy Compounding Advisory Committee, Center for Drug Evaluation and Research. 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 14, 2014 will be given first consideration for membership on the Pharmacy Compounding Advisory Committee. Nominations received after March 14, 2014 will be considered for nomination to the committee if nominees are still needed. SUMMARY: E:\FR\FM\13JAN1.SGM 13JAN1 2180 Federal Register / Vol. 79, No. 8 / Monday, January 13, 2014 / Notices All nominations for membership should be sent electronically to cv@oc.fda.gov, or by mail to Advisory Committee Oversight and Management Staff, 10903 New Hampshire Ave., Bldg. 32, Rm. 5103, Silver Spring, MD 20993–0002. Information about becoming a member on an FDA advisory committee can also be obtained by visiting FDA’s Web site at: https://www.fda.gov/ AdvisoryCommittees/default.htm. FOR FURTHER INFORMATION CONTACT: Jayne E. Peterson, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993, 301–796– 9001; FAX: 301–847–8533, email: PCAC@fda.hhs.gov. SUPPLEMENTARY INFORMATION: FDA is requesting nominations for voting members on the Pharmacy Compounding Advisory Committee (the Committee). ADDRESSES: I. General Description of the Committee’s Duties The Committee provides advice on scientific, technical, and medical issues concerning drug compounding under sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353a and 353b), and as required, any other product for which FDA has regulatory responsibility. The Committee also makes appropriate recommendations to the Commissioner of Food and Drugs. tkelley on DSK3SPTVN1PROD with NOTICES II. Criteria for Voting Members Persons nominated for membership must have adequately diversified research and/or experience appropriate to the work of the Committee in such fields as pharmaceutical compounding, pharmaceutical manufacturing, pharmacy, medicine, and related specialties. These members will include representatives from the National Association of Boards of Pharmacy, the United States Pharmacopoeia, pharmacists with current experience and expertise in compounding, physicians with background and knowledge in compounding, and patient and public health advocacy organizations. The specialized training and experience necessary to qualify the nominee as an expert suitable for appointment is subject to review, but may include experience in medical practice, pharmacy practice, teaching, research, and/or public service relevant to the field of activity of the Committee. Members will be invited to serve for terms of up to 4 years. VerDate Mar<15>2010 16:40 Jan 10, 2014 Jkt 232001 III. Nomination Procedure Any interested person may nominate one or more qualified persons for membership on the Committee. Selfnominations are also accepted. Nominations should include a cover ´ ´ letter and a current, complete resume or curriculum vitae for each nominee, including a current business address and/or home address, telephone number, and email address if available. Nominations should also specify the advisory committee for which the nominee is recommended. Nominations should state that the nominee is aware of the nomination unless selfnominated. Nominations should also state that the nominee is willing to serve as a member of the advisory committee if selected and appears to have no conflict of interest. FDA will ask potential candidates to provide detailed information concerning such matters as financial holdings, employment, and research grants and/or contracts in order to permit evaluation of possible sources of conflict of interest. Elsewhere in this issue of the Federal Register, FDA is publishing a notice for industry organizations to participate in the nominations for and selection of industry representatives for the Committee, a notice for consumer organizations to participate in the nominations for and selection of the consumer representative for the Committee, and a final rule updating information regarding the Committee. 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. Dated: January 7, 2014. Jill Hartzler Warner, Acting Associate Commissioner for Special Medical Programs. [FR Doc. 2014–00318 Filed 1–10–14; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center For Scientific Review; 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 PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 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: Center for Scientific Review Special Emphasis Panel; Member Conflict: Neurobiology of Memory Formation. Date: January 16, 2014. Time: 3:30 p.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Telephone Conference Call). Contact Person: Wei-Qin Zhao, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5181 MSC 7846, Bethesda, MD 20892–7846, 301– 435–1236, zhaow@csr.nih.gov. This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. Name of Committee: Population Sciences and Epidemiology Integrated Review Group; Behavioral Genetics and Epidemiology Study Section. Date: February 3, 2014. Time: 8:00 a.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: Marines’ Memorial Club and Hotel, 609 Sutter Street, San Francisco, CA 94102. Contact Person: George Vogler, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3140, MSC 7770, Bethesda, MD 20892, (301) 237– 2693, voglergp@csr.nih.gov. Name of Committee: Interdisciplinary Molecular Sciences and Training Integrated Review Group; Enabling Bioanalytical and Imaging Technologies Study Section. Date: February 5–6, 2014. Time: 8:00 a.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: Hilton Alexandria Old Town, 1767 King Street, Alexandria, VA 22314. Contact Person: Dennis Hlasta, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 6185, MSC, Bethesda, MD 20892, 301–435–1047, dennis.hlasta@nih.gov. Name of Committee: Cell Biology Integrated Review Group; Cellular Mechanisms in Aging and Development Study Section. Date: February 6–7, 2014. Time: 8:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: St. Gregory Hotel, 2033 M Street NW., Washington, DC 20036. Contact Person: John Burch, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institute of Health, 6701 Rockledge Drive, Room 3213, MSC 7808, Bethesda, MD 20892, 301–408– 9519, burchjb@csr.nih.gov. E:\FR\FM\13JAN1.SGM 13JAN1

Agencies

[Federal Register Volume 79, Number 8 (Monday, January 13, 2014)]
[Notices]
[Pages 2179-2180]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-00318]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0001]


Request for Nominations for Voting Members on a Public Advisory 
Committee; Pharmacy Compounding Advisory Committee

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is requesting 
nominations for 12 voting members to serve on the Pharmacy Compounding 
Advisory Committee, Center for Drug Evaluation and Research.
    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 14, 2014 will be given 
first consideration for membership on the Pharmacy Compounding Advisory 
Committee. Nominations received after March 14, 2014 will be considered 
for nomination to the committee if nominees are still needed.

[[Page 2180]]


ADDRESSES: All nominations for membership should be sent electronically 
to cv@oc.fda.gov, or by mail to Advisory Committee Oversight and 
Management Staff, 10903 New Hampshire Ave., Bldg. 32, Rm. 5103, Silver 
Spring, MD 20993-0002. Information about becoming a member on an FDA 
advisory committee can also be obtained by visiting FDA's Web site at: 
https://www.fda.gov/AdvisoryCommittees/default.htm.

FOR FURTHER INFORMATION CONTACT: Jayne E. Peterson, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993, 301-796-
9001; FAX: 301-847-8533, email: PCAC@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: FDA is requesting nominations for voting 
members on the Pharmacy Compounding Advisory Committee (the Committee).

I. General Description of the Committee's Duties

    The Committee provides advice on scientific, technical, and medical 
issues concerning drug compounding under sections 503A and 503B of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353a and 353b), and as 
required, any other product for which FDA has regulatory 
responsibility. The Committee also makes appropriate recommendations to 
the Commissioner of Food and Drugs.

II. Criteria for Voting Members

    Persons nominated for membership must have adequately diversified 
research and/or experience appropriate to the work of the Committee in 
such fields as pharmaceutical compounding, pharmaceutical 
manufacturing, pharmacy, medicine, and related specialties. These 
members will include representatives from the National Association of 
Boards of Pharmacy, the United States Pharmacopoeia, pharmacists with 
current experience and expertise in compounding, physicians with 
background and knowledge in compounding, and patient and public health 
advocacy organizations.
    The specialized training and experience necessary to qualify the 
nominee as an expert suitable for appointment is subject to review, but 
may include experience in medical practice, pharmacy practice, 
teaching, research, and/or public service relevant to the field of 
activity of the Committee. Members will be invited to serve for terms 
of up to 4 years.

III. Nomination Procedure

    Any interested person may nominate one or more qualified persons 
for membership on the Committee. Self-nominations are also accepted. 
Nominations should include a cover letter and a current, complete 
r[eacute]sum[eacute] or curriculum vitae for each nominee, including a 
current business address and/or home address, telephone number, and 
email address if available. Nominations should also specify the 
advisory committee for which the nominee is recommended. Nominations 
should state that the nominee is aware of the nomination unless self-
nominated. Nominations should also state that the nominee is willing to 
serve as a member of the advisory committee if selected and appears to 
have no conflict of interest. FDA will ask potential candidates to 
provide detailed information concerning such matters as financial 
holdings, employment, and research grants and/or contracts in order to 
permit evaluation of possible sources of conflict of interest.
    Elsewhere in this issue of the Federal Register, FDA is publishing 
a notice for industry organizations to participate in the nominations 
for and selection of industry representatives for the Committee, a 
notice for consumer organizations to participate in the nominations for 
and selection of the consumer representative for the Committee, and a 
final rule updating information regarding the Committee.
    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.

    Dated: January 7, 2014.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2014-00318 Filed 1-10-14; 8:45 am]
BILLING CODE 4160-01-P
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