83 FR 13133 - Request for Nominations for Voting Members on a Public Advisory Committee; Pharmacy Compounding Advisory Committee

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 59 (March 27, 2018)

Page Range		13133-13134
FR Document		2018-06062

The Food and Drug Administration (FDA) is requesting nominations for members to serve on the Pharmacy Compounding Advisory Committee (Committee), Division of Advisory Committee Consultant Management, Center for Drug Evaluation and Research. The Committee provides advice on scientific, technical, and medical issues concerning human drug compounding under the Federal Food, Drug, and Cosmetic Act (FD&C Act), and, as required, any other product for which FDA has regulatory responsibility, and makes appropriate recommendations to the Commissioner of Food and Drugs. 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.

Federal Register, Volume 83 Issue 59 (Tuesday, March 27, 2018)

[Federal Register Volume 83, Number 59 (Tuesday, March 27, 2018)]
[Notices]
[Pages 13133-13134]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-06062]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-0965]


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 members to serve on the Pharmacy Compounding Advisory 
Committee (Committee), Division of Advisory Committee Consultant 
Management, Center for Drug Evaluation and Research. The Committee 
provides advice on scientific, technical, and medical issues concerning 
human drug compounding under the Federal Food, Drug, and Cosmetic Act 
(FD&C Act), and, as required, any other product for which FDA has 
regulatory responsibility, and makes appropriate recommendations to the 
Commissioner of Food and Drugs.
    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 May 29, 2018, will be given 
first consideration for membership on the Pharmacy Compounding Advisory 
Committee. Nominations received after May 29, 2018, will be considered 
for nominations 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: Cindy Chee, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002; 301-
796-9001, Fax: 301-847-8533, email: [email protected].
    Information about becoming a member on an FDA advisory committee 
can also be obtained by visiting FDA's website by using the following 
link: https://www.fda.gov/AdvisoryCommittees/default.htm.

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

[[Page 13134]]

I. General Description of the Committee's Duties

    The Committee provides advice on scientific, technical, and medical 
issues concerning human drug compounding under sections 503A and 503B 
of the FD&C 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.
    In implementing sections 503A and section 503B of the FD&C Act, the 
Agency may consult the Committee on: (1) Drug products for inclusion on 
a list of drug products that have been withdrawn or removed from the 
market because such drug products or components of such drug products 
have been found to be unsafe or not effective, and therefore cannot be 
compounded; (2) bulk drug substances for inclusion on lists of bulk 
drug substances that may be used in compounding; and (3) drug products 
for inclusion on a list of drug products that present demonstrable 
difficulties for compounding.
    Meetings are held approximately two to three times a year, 
announced in the Federal Register, and are open to the public except as 
determined otherwise by the Commissioner or designee in accordance with 
the Government in the Sunshine Act (5 U.S.C. 552b(c)) and the Federal 
Advisory Committee Act. Notice of all meetings shall be given to the 
public.

II. Criteria for Voting Members

    The Committee consists of a core of 12 voting members including the 
Chair. Members and the Chair are selected by the Commissioner or 
designee from among authorities knowledgeable in the fields of 
pharmaceutical compounding, pharmaceutical manufacturing, pharmacy, 
medicine, and related specialties. These members will include 
representatives from the National Association of Boards of Pharmacy, 
the U.S. Pharmacopeia, pharmacists with current experience and 
expertise in compounding, physicians with background and knowledge in 
compounding, and patient and public health advocacy organizations. 
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 
r[eacute]sum[eacute] or curriculum vitae for each nominee and a signed 
copy of the Acknowledgement and Consent form available at the FDA 
Advisory Nomination Portal (see ADDRESSES). Nominations must also 
specify the advisory committee for which the nominee is 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.

    Dated: March 21, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-06062 Filed 3-26-18; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 83, No. 59 / Tuesday, March 27, 2018 / Notices 13133

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Total Average
Number of responses Total
Activity FDA form No. annual burden per
respondents per hours
responses response
respondent

Initial consultation .................................... None 20 2 40 4 160
Final consultation ..................................... 3665 12 1 12 150 1,800

Total .................................................. ........................ ........................ ........................ ........................ ........................ 1,960
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

Our estimate is based on the conducted about the bioengineered food Committee provides advice on
information collection activities that is intended to be introduced into scientific, technical, and medical issues
discussed below. commercial distribution. FDA evaluates concerning human drug compounding
the submission to ensure that all under the Federal Food, Drug, and
Initial Consultations
potential safety and regulatory questions Cosmetic Act (FD&C Act), and, as
Initial consultations are generally a have been addressed. FDA has required, any other product for which
one-time burden, although a developer developed a form that prompts a FDA has regulatory responsibility, and
might return more than once to discuss developer to include certain elements in makes appropriate recommendations to
additional issues before submitting a the final consultation in a standard the Commissioner of Food and Drugs.
final consultation. As noted in the format: Form FDA 3665 entitled, ‘‘Final FDA seeks to include the views of
guidance, FDA encourages developers to Consultation for Food Derived From a women and men, members of all racial
consult early in the development phase New Plant Variety (Biotechnology Final and ethnic groups, and individuals with
of their products, and as often as Consultation).’’ The form, and elements and without disabilities on its advisory
necessary. Historically, firms that would be prepared as attachments committees and, therefore, encourages
developing a new bioengineered plant to the form, can be submitted in nominations of appropriately qualified
variety intended for food use have electronic format. candidates from these groups.
generally initiated consultation with We base our estimate of the average DATES: Nominations received on or
FDA early in the process of developing time to prepare a submission on before May 29, 2018, will be given first
such a variety, even though there is no informal contact with firms that made consideration for membership on the
legal obligation for such consultation. one or more biotechnology consultation Pharmacy Compounding Advisory
These consultations have served to submission under the voluntary Committee. Nominations received after
make FDA aware of foods and food biotechnology consultation process. As May 29, 2018, will be considered for
ingredients before these products are such, we estimate the average time to nominations to the Committee as later
distributed commercially, and have prepare a submission for final vacancies occur.
provided FDA with the information consultation to be 150 hours. ADDRESSES: All nominations for
necessary to address any potential
Dated: March 21, 2018. membership should be sent
questions regarding the safety, labeling,
Leslie Kux, electronically by logging into the FDA
or regulatory status of the food or food
Advisory Nomination Portal: https://
ingredient. As such, these consultations Associate Commissioner for Policy.
www.accessdata.fda.gov/scripts/
have provided assistance to both [FR Doc. 2018–06069 Filed 3–26–18; 8:45 am]
FACTRSPortal/FACTRS/index.cfm or by
industry and the Agency in exercising BILLING CODE 4164–01–P
mail to Advisory Committee Oversight
their mutual responsibilities under the
and Management Staff, Food and Drug
FD&C Act.
FDA estimates that CVM and CFSAN Administration, 10903 New Hampshire
DEPARTMENT OF HEALTH AND
jointly received an average of 40 initial Ave., Bldg. 32, Rm. 5103, Silver Spring,
HUMAN SERVICES
consultations per year in the last 3 years MD 20993–0002.
via telephone, email, or written letter. Food and Drug Administration FOR FURTHER INFORMATION CONTACT:
Based on this information, we expect to Regarding all nomination questions for
[Docket No. FDA–2018–N–0965] membership, the primary contact is:
receive no more than 40 annually in the
next 3 years. Cindy Chee, Center for Drug Evaluation
Request for Nominations for Voting
and Research, Food and Drug
Final Consultations Members on a Public Advisory
Administration, 10903 New Hampshire
Committee; Pharmacy Compounding
Final consultations are a one-time Ave., Bldg. 31, Rm. 2417, Silver Spring,
Advisory Committee
burden. At some stage in the process of MD 20993–0002; 301–796–9001, Fax:
research and development, a developer AGENCY: Food and Drug Administration, 301–847–8533, email: PCAC@
will have accumulated the information HHS. fda.hhs.gov.
that the developer believes is adequate ACTION: Notice. Information about becoming a
to ensure that food derived from the member on an FDA advisory committee
new plant variety is safe and that it SUMMARY: The Food and Drug can also be obtained by visiting FDA’s
amozie on DSK30RV082PROD with NOTICES

demonstrates compliance with the Administration (FDA) is requesting website by using the following link:
relevant provisions of the FD&C Act. nominations for members to serve on https://www.fda.gov/
The developer will then be in a position the Pharmacy Compounding Advisory AdvisoryCommittees/default.htm.
to conclude any ongoing consultation Committee (Committee), Division of SUPPLEMENTARY INFORMATION: FDA is
with FDA. The developer submits to Advisory Committee Consultant requesting nominations for voting
FDA a summary of the safety and Management, Center for Drug members on the Pharmacy
nutritional assessment that has been Evaluation and Research. The Compounding Advisory Committee.

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13134 Federal Register / Vol. 83, No. 59 / Tuesday, March 27, 2018 / Notices

I. General Description of the complete résumé or curriculum vitae for Devices’’ would be held on April 30,
Committee’s Duties each nominee and a signed copy of the 2018. On page 6188, in the third
The Committee provides advice on Acknowledgement and Consent form column, the DATES portion of the
scientific, technical, and medical issues available at the FDA Advisory document is changed to reflect new start
concerning human drug compounding Nomination Portal (see ADDRESSES). and end times to read as follows:
under sections 503A and 503B of the Nominations must also specify the DATES: The public workshop will be
FD&C Act (21 U.S.C. 353a and 353b), advisory committee for which the held on April 30, 2018, from 8 a.m. to
and, as required, any other product for nominee is recommended. Nominations 5:30 p.m. Submit either electronic or
which FDA has regulatory must also acknowledge that the written comments on this public
responsibility, and makes appropriate nominee is aware of the nomination workshop by May 29, 2018. See the
recommendations to the Commissioner unless self-nominated. FDA will ask SUPLLEMENTARY INFORMATION section for
of Food and Drugs. potential candidates to provide detailed registration date and information.
In implementing sections 503A and information concerning such matters
Dated: March 21, 2018.
section 503B of the FD&C Act, the related to financial holdings,
Leslie Kux,
Agency may consult the Committee on: employment, and research grants and/or
contracts to permit evaluation of Associate Commissioner for Policy.
(1) Drug products for inclusion on a list [FR Doc. 2018–06064 Filed 3–26–18; 8:45 am]
of drug products that have been possible sources of conflicts of interest.
withdrawn or removed from the market This notice is issued under the BILLING CODE 4164–01–P

because such drug products or Federal Advisory Committee Act (5
components of such drug products have U.S.C. app. 2) and 21 CFR part 14,
relating to advisory committees. DEPARTMENT OF HEALTH AND
been found to be unsafe or not effective, HUMAN SERVICES
and therefore cannot be compounded; Dated: March 21, 2018.
(2) bulk drug substances for inclusion Leslie Kux, Food and Drug Administration
on lists of bulk drug substances that Associate Commissioner for Policy.
[Docket No. FDA–2018–D–0943]
may be used in compounding; and (3) [FR Doc. 2018–06062 Filed 3–26–18; 8:45 am]
drug products for inclusion on a list of BILLING CODE 4164–01–P Elemental Impurities in Animal Drug
drug products that present demonstrable Products—Questions and Answers;
difficulties for compounding. Draft Guidance for Industry;
Meetings are held approximately two DEPARTMENT OF HEALTH AND Availability
to three times a year, announced in the HUMAN SERVICES
Federal Register, and are open to the AGENCY: Food and Drug Administration,
public except as determined otherwise Food and Drug Administration HHS.
by the Commissioner or designee in [Docket No. FDA–2018–N–0235] ACTION: Notice of availability.
accordance with the Government in the
Sunshine Act (5 U.S.C. 552b(c)) and the Orthopaedic Sensing, Measuring, and SUMMARY: The Food and Drug
Federal Advisory Committee Act. Notice Advanced Reporting Technology Administration (FDA or Agency) is
of all meetings shall be given to the Devices; Public Workshop; Request announcing the availability of a draft
public. for Comments; Amendment of Notice guidance for industry (GFI) #255
entitled ‘‘Elemental Impurities in
II. Criteria for Voting Members AGENCY: Food and Drug Administration, Animal Drug Products—Questions and
The Committee consists of a core of HHS. Answers.’’ This guidance is intended to
12 voting members including the Chair. ACTION: Notice. assist sponsors of animal drug products
Members and the Chair are selected by in addressing changes in the United
the Commissioner or designee from SUMMARY: The Food and Drug States Pharmacopeia (USP)
among authorities knowledgeable in the Administration (FDA, the Agency, or requirements for the control of
fields of pharmaceutical compounding, we) is announcing an amendment to the elemental impurities in drug products
pharmaceutical manufacturing, notice of public workshop entitled marketed in the United States.
pharmacy, medicine, and related ‘‘Orthopaedic Sensing, Measuring, and DATES: Submit either electronic or
specialties. These members will include Advanced Reporting Technology written comments on the draft guidance
representatives from the National (SMART) Devices.’’ That workshop was by May 29, 2018 to ensure that the
Association of Boards of Pharmacy, the announced in the Federal Register of Agency considers your comment on this
U.S. Pharmacopeia, pharmacists with February 13, 2018. The amendment is draft guidance before it begins work on
current experience and expertise in being made to reflect a change in the the final version of the guidance.
DATES portion of the document. There
compounding, physicians with ADDRESSES: You may submit comments
background and knowledge in are no other changes.
on any guidance at any time as follows:
compounding, and patient and public FOR FURTHER INFORMATION CONTACT:
health advocacy organizations. Almost Andrew Baumann, Center for Devices Electronic Submissions
all non-Federal members of this and Radiological Health, Food and Drug Submit electronic comments in the
committee serve as Special Government Administration, 10903 New Hampshire following way:
Employees. Members will be invited to Ave., Bldg. 62, Rm. 2110, Silver Spring, • Federal eRulemaking Portal:
serve for terms of up to 4 years. MD 20993, 301–796–2508, https://www.regulations.gov. Follow the
amozie on DSK30RV082PROD with NOTICES

andrew.baumann@fda.hhs.gov. instructions for submitting comments.
III. Nomination Procedures SUPPLEMENTARY INFORMATION: In the Comments submitted electronically,
Any interested person may nominate Federal Register of February 13, 2018 including attachments, to https://
one or more qualified individuals for (83 FR 6188), FDA announced that a www.regulations.gov will be posted to
membership on the advisory committee. public workshop entitled ‘‘Orthopaedic the docket unchanged. Because your
Self-nominations are also accepted. Sensing, Measuring, and Advanced comment will be made public, you are
Nominations must include a current, Reporting Technology (SMART) solely responsible for ensuring that your

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Document Created: 2018-03-27 01:26:49
Document Modified: 2018-03-27 01:26:49

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Nominations received on or before May 29, 2018, will be given first consideration for membership on the Pharmacy Compounding Advisory Committee. Nominations received after May 29, 2018, will be considered for nominations to the Committee as later vacancies occur.
Contact		Regarding all nomination questions for membership, the primary contact is: Cindy Chee, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002; 301- 796-9001, Fax: 301-847-8533, email: [email protected]
FR Citation		83 FR 13133

83 FR 13133 - Request for Nominations for Voting Members on a Public Advisory Committee; Pharmacy Compounding Advisory Committee

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 59 (March 27, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration