Request for Nominations for a Voting Consumer Representative on the Pharmacy Compounding Advisory Committee and Request for Notification From Consumer Organizations Interested in Participating in the Selection Process for Nominations for a Voting Consumer Representative on the Pharmacy Compounding Advisory Committee, 2178-2179 [2014-00319]

Download as PDF 2178 Federal Register / Vol. 79, No. 8 / Monday, January 13, 2014 / Notices one representative of the pharmaceutical manufacturing industry. With this notice, nominations are being sought for one representative from the pharmacy compounding industry and one representative from the pharmaceutical manufacturing industry. II. Criteria for Nonvoting Members Any pharmacy compounding organization and any pharmaceutical manufacturing organization interested in participating in the selection of an appropriate nonvoting member to represent industry interests should send a letter stating that interest to the FDA contact (see FOR FURTHER INFORMATION CONTACT) within 30 days of publication of this document (see DATES). Within the subsequent 30 days, FDA will send a letter to each pharmacy compounding organization that has expressed an interest and attach a complete list of all such organizations. A list of all nominees from the pharmacy compounding industry along ´ ´ with their current resumes will also be attached. The letter will also state that it is the responsibility of the interested organizations to confer with one another and select a candidate to serve as the nonvoting member to represent the pharmacy compounding industry on the committee within 60 days of receiving the FDA letter. FDA will send similar letters to the pharmaceutical manufacturing organizations that have expressed interest, and they will be expected to follow a similar process to select their nominee. Interested organizations are not bound by the list of nominees when selecting a candidate. However, if no individual is selected within 60 days, the Commissioner will select the nonvoting member in each category to represent industry interests. nominations to the organizations expressing interest in participating in the selection process for the Committee. (Persons who nominate themselves as nonvoting industry 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 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. 2014–00320 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 a Voting Consumer Representative on the Pharmacy Compounding Advisory Committee and Request for Notification From Consumer Organizations Interested in Participating in the Selection Process for Nominations for a Voting Consumer Representative on the Pharmacy Compounding Advisory Committee AGENCY: Food and Drug Administration, HHS. Notice. tkelley on DSK3SPTVN1PROD with NOTICES III. Nomination Procedure ACTION: Individuals may self-nominate, and/or an organization may nominate one or more individuals to serve as a nonvoting industry representative. Nominations should include contact information and ´ ´ a current, complete resume or curriculum vitae for each nominee. Nominations should also include the name of the Committee and should be sent to the FDA contact person (see FOR FURTHER INFORMATION CONTACT) within 30 days of publication of this document (see DATES). FDA will forward all SUMMARY: VerDate Mar<15>2010 16:40 Jan 10, 2014 Jkt 232001 The Food and Drug Administration (FDA) is requesting that any consumer organizations interested in participating in the selection of a voting consumer representative to serve on the Pharmacy Compounding Advisory Committee notify FDA in writing. FDA is also requesting nominations for a voting consumer representative to serve on the Pharmacy Compounding Advisory Committee for which a vacancy currently exists. Nominees recommended to serve as the PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 voting consumer representative may be self-nominated or nominated by a consumer organization. Nominations will be accepted for the current vacancy through February 12, 2014. 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: Any consumer organization interested in participating in the selection of an appropriate voting member to represent consumer interests on an FDA advisory committee should send a letter or email stating that interest to FDA (see ADDRESSES) by February 12, 2014, for the vacancy in this notice. Concurrently, nomination materials for prospective candidates should be sent to FDA (see ADDRESSES) by February 12, 2014. ADDRESSES: All statements of interest from consumer organizations interested in participating in the selection process and consumer representative nominations should be sent electronically to cv@oc.fda.gov, or by mail to Advisory Committee Oversight and Management Staff, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5129, Silver Spring, MD 20993–0002, FAX: 301–847–8640. Information about becoming a member of an FDA advisory committee can be obtained by visiting FDA’s Web site at https://www.fda.gov/ AdvisoryCommittees/default.htm. FOR FURTHER INFORMATION CONTACT: Dornette Spell-LeSane, Advisory Committee Oversight and Management Staff, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5129, Silver Spring, MD 20993– 0002, 301–796–8224, email: dornette.spelllesane@fda.hhs.gov. For questions relating to the Pharmacy Compounding Advisory Committee, 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 a voting consumer representative listed in table 1: E:\FR\FM\13JAN1.SGM 13JAN1 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

Agencies

[Federal Register Volume 79, Number 8 (Monday, January 13, 2014)]
[Notices]
[Pages 2178-2179]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-00319]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

Request for Nominations for a Voting Consumer Representative on
the Pharmacy Compounding Advisory Committee and Request for
Notification From Consumer Organizations Interested in Participating in
the Selection Process for Nominations for a Voting Consumer
Representative on the Pharmacy Compounding Advisory Committee

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is requesting that any
consumer organizations interested in participating in the selection of
a voting consumer representative to serve on the Pharmacy Compounding
Advisory Committee notify FDA in writing. FDA is also requesting
nominations for a voting consumer representative to serve on the
Pharmacy Compounding Advisory Committee for which a vacancy currently
exists. Nominees recommended to serve as the voting consumer
representative may be self-nominated or nominated by a consumer
organization. Nominations will be accepted for the current vacancy
through February 12, 2014.
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: Any consumer organization interested in participating in the
selection of an appropriate voting member to represent consumer
interests on an FDA advisory committee should send a letter or email
stating that interest to FDA (see ADDRESSES) by February 12, 2014, for
the vacancy in this notice. Concurrently, nomination materials for
prospective candidates should be sent to FDA (see ADDRESSES) by
February 12, 2014.

ADDRESSES: All statements of interest from consumer organizations
interested in participating in the selection process and consumer
representative nominations should be sent electronically to
cv@oc.fda.gov, or by mail to Advisory Committee Oversight and
Management Staff, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 32, Rm. 5129, Silver Spring, MD 20993-0002, FAX: 301-847-
8640. Information about becoming a member of an FDA advisory committee
can be obtained by visiting FDA's Web site at https://www.fda.gov/AdvisoryCommittees/default.htm.

FOR FURTHER INFORMATION CONTACT: Dornette Spell-LeSane, Advisory
Committee Oversight and Management Staff, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 32, Rm. 5129, Silver Spring, MD 20993-
0002, 301-796-8224, email: dornette.spelllesane@fda.hhs.gov.
For questions relating to the Pharmacy Compounding Advisory
Committee, 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 a voting
consumer representative listed in table 1:

[[Page 2179]]

Table 1--Committee Description, Type of Consumer Representative
Vacancy, and Approximate Date Needed
------------------------------------------------------------------------
Committee areas of expertise Approximate date
needed Current vacancies needed
------------------------------------------------------------------------
Pharmacy Compounding-- 1--Voting........ Immediately.
Knowledgeable in the fields
of pharmaceutical
compounding; pharmaceutical
manufacturing; pharmacy,
medicine, and related
specialties.
------------------------------------------------------------------------

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.

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 the Agency based on the nominations
received, along with each nominee's current curriculum vitae or
r[eacute]sum[eacute]. 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
r[eacute]sum[eacute] 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 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

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