81_FR_7379 81 FR 7351 - Pharmacy Compounding Advisory Committee; Notice of Meeting

81 FR 7351 - Pharmacy Compounding Advisory Committee; Notice of Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 28 (February 11, 2016)

Page Range7351-7352
FR Document2016-02786

This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Pharmacy Compounding Advisory Committee (PCAC). General Function of the Committee: To provide advice on scientific, technical, and medical issues concerning drug compounding under sections 503A and 503B (21 U.S.C. 353A and 353B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), and, as required, any other product for which FDA has regulatory responsibility, and make appropriate recommendations to the Commissioner of Food and Drugs. Date and Time: The meeting will be held on March 8, 2016, from 8:30 a.m. to 4:30 p.m., and on March 9, 2016, from 8:30 a.m. to 1 p.m. Location: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (rm. 1503), Silver Spring, MD 20993- 0002. Answers to commonly asked questions including information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at: http://www.fda.gov/ AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.

Federal Register, Volume 81 Issue 28 (Thursday, February 11, 2016)
[Federal Register Volume 81, Number 28 (Thursday, February 11, 2016)]
[Notices]
[Pages 7351-7352]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-02786]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0001]


Pharmacy Compounding Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: This notice announces a forthcoming meeting of a public 
advisory committee of the Food and Drug Administration (FDA). The 
meeting will be open to the public.
    Name of Committee: Pharmacy Compounding Advisory Committee (PCAC).
    General Function of the Committee: To provide advice on scientific, 
technical, and medical issues concerning drug compounding under 
sections 503A and 503B (21 U.S.C. 353A and 353B) of the Federal Food, 
Drug, and Cosmetic Act (FD&C Act), and, as required, any other product 
for which FDA has regulatory responsibility, and make appropriate 
recommendations to the Commissioner of Food and Drugs.
    Date and Time: The meeting will be held on March 8, 2016, from 8:30 
a.m. to 4:30 p.m., and on March 9, 2016, from 8:30 a.m. to 1 p.m.
    Location: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 
Conference Center, the Great Room (rm. 1503), Silver Spring, MD 20993-
0002. Answers to commonly asked questions including information 
regarding special accommodations due to a disability, visitor parking, 
and transportation may be accessed at: http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.

FOR FURTHER INFORMATION CONTACT: Cindy Hong, 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], or FDA Advisory Committee 
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC 
area). A notice in the Federal Register about last minute modifications 
that impact a previously announced advisory committee meeting cannot 
always be published quickly enough to provide timely notice. Therefore, 
you should always check the Agency's Web site at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate 
advisory committee meeting link, or call the advisory committee 
information line to learn about possible modifications before coming to 
the meeting.

SUPPLEMENTARY INFORMATION: 
    Background: Section 503A of the FD&C Act describes the conditions 
that must be satisfied for human drug products compounded by a licensed 
pharmacist or licensed physician to be exempt from the following three 
sections of the FD&C Act: (1) Section 501(a)(2)(B) (concerning current 
good manufacturing practice (CGMP)); (2) section 502(f)(1) (concerning 
the labeling of drugs with adequate directions for use); and (3) 
section 505 (21 U.S.C. 355) (concerning the approval of human drug 
products under new drug applications (NDAs) or abbreviated new drug 
applications (ANDAs)).
    The Drug Quality and Security Act adds a new section, 503B, to the 
FD&C Act that creates a new category of ``outsourcing facilities.'' 
Outsourcing facilities, as defined in section 503B of the FD&C Act, are 
facilities that meet certain conditions described in section 503B, 
including registration with FDA as an outsourcing facility. If these 
conditions are satisfied, a drug product compounded for human use by or 
under the direct supervision of a licensed pharmacist in an outsourcing 
facility is exempt from three sections of the FD&C Act: (1) Section 
502(f)(1), concerning the labeling of drugs with adequate directions 
for use; (2) section 505, concerning the approval of human drug 
products under NDAs or ANDAs; and (3) section 582, concerning the track 
and trace requirements in the Drug Supply Chain Security Act (Pub. L. 
113-53). Outsourcing facilities are not exempt from CGMP requirements 
in section 501(a)(2)(B) of the FD&C Act.
    One of the conditions that must be satisfied to qualify for the 
exemptions under section 503A of the FD&C Act is that a bulk drug 
substance (active pharmaceutical ingredient) used in a compounded drug 
product must meet one of the following criteria: (1) Complies with the 
standards of an applicable United States Pharmacopoeia (USP) or 
National Formulary monograph, if a monograph exists, and the USP 
chapter on pharmacy compounding; (2) if an applicable monograph does 
not exist, is a component of a drug approved by the Secretary of Health 
and Human Services (the Secretary); or (3) if such a monograph does not 
exist and the drug substance is not a component of a drug approved by 
the Secretary, appears on a list (the ``section 503A bulk drug 
substances list'') developed by the Secretary through regulations 
issued by the Secretary (see section 503A(b)(1)(A)(i) of the FD&C Act).
    Another condition that must be satisfied to qualify for the 
exemptions under section 503A of the FD&C Act is that the compounded 
drug product is not a drug product identified by the Secretary by 
regulation as a drug product that presents demonstrable difficulties 
for compounding that reasonably demonstrate an adverse effect on the 
safety or effectiveness of that drug product (see section 503A(b)(3)(A) 
of the FD&C Act).
    A condition that must be satisfied to qualify for the exemptions in 
section 503B of the FD&C Act is that the compounded drug is not 
identified (directly or as part of a category of drugs) on a list 
published by the Secretary, by regulation after consulting with the 
Pharmacy Compounding Advisory Committee, of drugs or categories of 
drugs that present demonstrable difficulties for compounding that are 
reasonably likely

[[Page 7352]]

to lead to an adverse effect on the safety or effectiveness of the drug 
or category of drugs, taking into account the risks and benefits to 
patients, or the drug is compounded in accordance with all applicable 
conditions identified on the list as conditions that are necessary to 
prevent the drug or category of drugs from presenting such demonstrable 
difficulties (see section 503B(a)(6)(A) and (B) of the FD&C Act).
    FDA will discuss with the committee drugs proposed for inclusion on 
the section 503A bulk drug substances list and on the demonstrably 
difficult to compound list under sections 503A and 503B of the FD&C 
Act.
    Agenda: On March 8, 2016, the committee will discuss six bulk drug 
substances nominated for inclusion on the section 503A bulk drug 
substances list. FDA will discuss the following nominated bulk drug 
substances: Quinacrine hydrochloride, boswellia, aloe vera 200:1 freeze 
dried, D-ribose, chondroitin sulfate, and acetyl-L-carnitine. The 
nominators of these substances will be invited to make a short 
presentation supporting the nomination.
    On March 9, 2016, the committee will discuss two categories of drug 
products nominated for the list of drug products that present 
demonstrable difficulties for compounding. These categories of drug 
products are metered dose inhalers and dry powder inhalers. The 
nominators who nominated the category of drugs or specific drug 
products in the category will be invited to make a short presentation 
supporting the nomination.
    FDA intends to make background material available to the public no 
later than 2 business days before the meeting. If FDA is unable to post 
the background material on its Web site prior to the meeting, the 
background material will be made publicly available at the location of 
the advisory committee meeting, and the background material will be 
posted on FDA's Web site after the meeting. Background material is 
available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting 
link.
    Procedure: Interested persons may present data, information, or 
views, orally or in writing, on issues pending before the committee. 
Written submissions may be made to the contact person on or before 
March 1, 2016. Oral presentations from the public will be scheduled 
between approximately 11 a.m. to 11:15 a.m. and 3:15 p.m. to 3:30 p.m. 
on March 8, 2016, and between approximately 11:30 a.m. to 12 noon on 
March 9, 2016. Those individuals interested in making formal oral 
presentations should notify the contact person and submit a brief 
statement of the general nature of the evidence or arguments they wish 
to present, the names and addresses of proposed participants, and an 
indication of the approximate time requested to make their presentation 
on or before February 24, 2016. Time allotted for each presentation may 
be limited. If the number of registrants requesting to speak is greater 
than can be reasonably accommodated during the scheduled open public 
hearing session, FDA may conduct a lottery to determine the speakers 
for the scheduled open public hearing session. The contact person will 
notify interested persons regarding their request to speak by February 
25, 2016.
    Persons attending FDA's advisory committee meetings are advised 
that the Agency is not responsible for providing access to electrical 
outlets.
    FDA welcomes the attendance of the public at its advisory committee 
meetings and will make every effort to accommodate persons with 
disabilities. If you require accommodations due to a disability, please 
contact Cindy Hong at least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee 
meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures 
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: February 8, 2016.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2016-02786 Filed 2-8-16; 4:15 pm]
 BILLING CODE 4164-01-P



                                                                              Federal Register / Vol. 81, No. 28 / Thursday, February 11, 2016 / Notices                                           7351

                                                  ensure their efficiency and                             sections 503A and 503B (21 U.S.C. 353A                the FD&C Act, are facilities that meet
                                                  effectiveness, and ensuring that these                  and 353B) of the Federal Food, Drug,                  certain conditions described in section
                                                  entities conform to federal laws,                       and Cosmetic Act (FD&C Act), and, as                  503B, including registration with FDA
                                                  regulations, policies, and procedures                   required, any other product for which                 as an outsourcing facility. If these
                                                  governing the programs.                                 FDA has regulatory responsibility, and                conditions are satisfied, a drug product
                                                     V. Continuation of Policy. Except as                 make appropriate recommendations to                   compounded for human use by or under
                                                  inconsistent with this reorganization, all              the Commissioner of Food and Drugs.                   the direct supervision of a licensed
                                                  statements of policy and interpretations                   Date and Time: The meeting will be                 pharmacist in an outsourcing facility is
                                                  with respect to organizational                          held on March 8, 2016, from 8:30 a.m.                 exempt from three sections of the FD&C
                                                  components affected by this notice                      to 4:30 p.m., and on March 9, 2016,                   Act: (1) Section 502(f)(1), concerning the
                                                  within ACF, heretofore issued and in                    from 8:30 a.m. to 1 p.m.                              labeling of drugs with adequate
                                                  effect on this date of this reorganization                 Location: FDA White Oak Campus,                    directions for use; (2) section 505,
                                                  are continued in full force and effect.                 10903 New Hampshire Ave., Bldg. 31                    concerning the approval of human drug
                                                     VI. Delegation of Authority. All                     Conference Center, the Great Room (rm.                products under NDAs or ANDAs; and
                                                  delegations and re-delegations of                       1503), Silver Spring, MD 20993–0002.                  (3) section 582, concerning the track and
                                                  authority made to officials and                         Answers to commonly asked questions                   trace requirements in the Drug Supply
                                                  employees of affected organizational                    including information regarding special               Chain Security Act (Pub. L. 113–53).
                                                  components will continue in them, or                    accommodations due to a disability,                   Outsourcing facilities are not exempt
                                                  their successors, pending further re-                   visitor parking, and transportation may               from CGMP requirements in section
                                                  delegations, provided they are                          be accessed at: http://www.fda.gov/                   501(a)(2)(B) of the FD&C Act.
                                                  consistent with this reorganization.                    AdvisoryCommittees/AboutAdvisory                         One of the conditions that must be
                                                     VII. Funds, Personnel, and                           Committees/ucm408555.htm.                             satisfied to qualify for the exemptions
                                                  Equipment. Transfer of organizations                    FOR FURTHER INFORMATION CONTACT:
                                                                                                                                                                under section 503A of the FD&C Act is
                                                  and functions affected by this                          Cindy Hong, Center for Drug Evaluation                that a bulk drug substance (active
                                                  reorganization shall be accompanied in                  and Research, Food and Drug                           pharmaceutical ingredient) used in a
                                                  each instance by direct and support                     Administration, 10903 New Hampshire                   compounded drug product must meet
                                                  funds, positions, personnel, records,                   Ave., Bldg. 31, rm. 2417, Silver Spring,              one of the following criteria: (1)
                                                  equipment, supplies, and other                          MD 20993–0002, 301–796–9001, FAX:                     Complies with the standards of an
                                                  resources.                                              301–847–8533, email: PCAC@                            applicable United States Pharmacopoeia
                                                                                                                                                                (USP) or National Formulary
                                                  FOR FURTHER INFORMATION CONTACT:                        fda.hhs.gov, or FDA Advisory
                                                                                                                                                                monograph, if a monograph exists, and
                                                  Linda K. Smith, Office of the Deputy                    Committee Information Line, 1–800–
                                                                                                                                                                the USP chapter on pharmacy
                                                  Assistant Secretary for Early Childhood                 741–8138 (301–443–0572 in the
                                                                                                                                                                compounding; (2) if an applicable
                                                  Development, 901 D Street SW.,                          Washington, DC area). A notice in the
                                                                                                                                                                monograph does not exist, is a
                                                  Washington, DC 20447, (202) 401–9200.                   Federal Register about last minute
                                                                                                                                                                component of a drug approved by the
                                                    This reorganization will be effective                 modifications that impact a previously
                                                                                                                                                                Secretary of Health and Human Services
                                                  upon date of signature.                                 announced advisory committee meeting
                                                                                                                                                                (the Secretary); or (3) if such a
                                                                                                          cannot always be published quickly
                                                    Dated: February 5, 2016.                                                                                    monograph does not exist and the drug
                                                                                                          enough to provide timely notice.
                                                  Sylvia M. Burwell,                                                                                            substance is not a component of a drug
                                                                                                          Therefore, you should always check the                approved by the Secretary, appears on a
                                                  Secretary.                                              Agency’s Web site at http://www.fda.
                                                  [FR Doc. 2016–02784 Filed 2–10–16; 8:45 am]                                                                   list (the ‘‘section 503A bulk drug
                                                                                                          gov/AdvisoryCommittees/default.htm                    substances list’’) developed by the
                                                  BILLING CODE 4184–01–P                                  and scroll down to the appropriate                    Secretary through regulations issued by
                                                                                                          advisory committee meeting link, or call              the Secretary (see section
                                                                                                          the advisory committee information line               503A(b)(1)(A)(i) of the FD&C Act).
                                                  DEPARTMENT OF HEALTH AND                                to learn about possible modifications
                                                  HUMAN SERVICES                                                                                                   Another condition that must be
                                                                                                          before coming to the meeting.                         satisfied to qualify for the exemptions
                                                  Food and Drug Administration                            SUPPLEMENTARY INFORMATION:                            under section 503A of the FD&C Act is
                                                                                                             Background: Section 503A of the                    that the compounded drug product is
                                                  [Docket No. FDA–2016–N–0001]                            FD&C Act describes the conditions that                not a drug product identified by the
                                                                                                          must be satisfied for human drug                      Secretary by regulation as a drug
                                                  Pharmacy Compounding Advisory                           products compounded by a licensed                     product that presents demonstrable
                                                  Committee; Notice of Meeting                            pharmacist or licensed physician to be                difficulties for compounding that
                                                  AGENCY:    Food and Drug Administration,                exempt from the following three                       reasonably demonstrate an adverse
                                                  HHS.                                                    sections of the FD&C Act: (1) Section                 effect on the safety or effectiveness of
                                                  ACTION:   Notice.                                       501(a)(2)(B) (concerning current good                 that drug product (see section
                                                                                                          manufacturing practice (CGMP)); (2)                   503A(b)(3)(A) of the FD&C Act).
                                                  SUMMARY:   This notice announces a                      section 502(f)(1) (concerning the                        A condition that must be satisfied to
                                                  forthcoming meeting of a public                         labeling of drugs with adequate                       qualify for the exemptions in section
                                                  advisory committee of the Food and                      directions for use); and (3) section 505              503B of the FD&C Act is that the
                                                  Drug Administration (FDA). The                          (21 U.S.C. 355) (concerning the approval              compounded drug is not identified
mstockstill on DSK4VPTVN1PROD with NOTICES




                                                  meeting will be open to the public.                     of human drug products under new                      (directly or as part of a category of
                                                    Name of Committee: Pharmacy                           drug applications (NDAs) or abbreviated               drugs) on a list published by the
                                                  Compounding Advisory Committee                          new drug applications (ANDAs)).                       Secretary, by regulation after consulting
                                                  (PCAC).                                                    The Drug Quality and Security Act                  with the Pharmacy Compounding
                                                    General Function of the Committee:                    adds a new section, 503B, to the FD&C                 Advisory Committee, of drugs or
                                                  To provide advice on scientific,                        Act that creates a new category of                    categories of drugs that present
                                                  technical, and medical issues                           ‘‘outsourcing facilities.’’ Outsourcing               demonstrable difficulties for
                                                  concerning drug compounding under                       facilities, as defined in section 503B of             compounding that are reasonably likely


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                                                  7352                        Federal Register / Vol. 81, No. 28 / Thursday, February 11, 2016 / Notices

                                                  to lead to an adverse effect on the safety              interested in making formal oral                      confidential trade secrets or commercial
                                                  or effectiveness of the drug or category                presentations should notify the contact               property such as patentable material,
                                                  of drugs, taking into account the risks                 person and submit a brief statement of                and personal information concerning
                                                  and benefits to patients, or the drug is                the general nature of the evidence or                 individuals associated with the grant
                                                  compounded in accordance with all                       arguments they wish to present, the                   applications, the disclosure of which
                                                  applicable conditions identified on the                 names and addresses of proposed                       would constitute a clearly unwarranted
                                                  list as conditions that are necessary to                participants, and an indication of the                invasion of personal privacy.
                                                  prevent the drug or category of drugs                   approximate time requested to make                      Name of Committee: National Institute of
                                                  from presenting such demonstrable                       their presentation on or before February              Biomedical Imaging and Bioengineering
                                                  difficulties (see section 503B(a)(6)(A)                 24, 2016. Time allotted for each                      Special Emphasis Panel; Career Award and
                                                  and (B) of the FD&C Act).                               presentation may be limited. If the                   Conference Grant Review (2016/05).
                                                     FDA will discuss with the committee                  number of registrants requesting to                     Date: March 18, 2016.
                                                  drugs proposed for inclusion on the                     speak is greater than can be reasonably                 Time: 9:00 a.m. to 6:00 p.m.
                                                  section 503A bulk drug substances list                                                                          Agenda: To review and evaluate grant
                                                                                                          accommodated during the scheduled                     applications.
                                                  and on the demonstrably difficult to                    open public hearing session, FDA may                    Place: National Institutes of Health, Two
                                                  compound list under sections 503A and                   conduct a lottery to determine the                    Democracy Plaza, Suite 920, 6707 Democracy
                                                  503B of the FD&C Act.                                   speakers for the scheduled open public                Boulevard, Bethesda, MD 20892 (Virtual
                                                     Agenda: On March 8, 2016, the                        hearing session. The contact person will              Meeting).
                                                  committee will discuss six bulk drug                    notify interested persons regarding their               Contact Person: Mark Martin, Ph.D.,
                                                  substances nominated for inclusion on                   request to speak by February 25, 2016.                Scientific Review Officer, 6707 Democracy
                                                  the section 503A bulk drug substances                      Persons attending FDA’s advisory                   Boulevard, Suite 920, Bethesda, MD 20892,
                                                  list. FDA will discuss the following                                                                          (240) 447–2148, mark.martin@mail.nih.gov.
                                                                                                          committee meetings are advised that the
                                                  nominated bulk drug substances:                         Agency is not responsible for providing                 Name of Committee: National Institute of
                                                  Quinacrine hydrochloride, boswellia,                                                                          Biomedical Imaging and Bioengineering
                                                                                                          access to electrical outlets.                         Special Emphasis Panel; P41 BTRC review
                                                  aloe vera 200:1 freeze dried, D-ribose,                    FDA welcomes the attendance of the                 (2016/05).
                                                  chondroitin sulfate, and acetyl-L-                      public at its advisory committee                        Date: March 23–25, 2016.
                                                  carnitine. The nominators of these                      meetings and will make every effort to                  Time: 6:00 p.m. to 1:00 p.m.
                                                  substances will be invited to make a                    accommodate persons with disabilities.                  Agenda: To review and evaluate grant
                                                  short presentation supporting the                       If you require accommodations due to a                applications.
                                                  nomination.                                             disability, please contact Cindy Hong at                Place: Wyndham Boston Beacon Hill, 5
                                                     On March 9, 2016, the committee will                 least 7 days in advance of the meeting.               Blossom Street, Boston, MA 02114.
                                                  discuss two categories of drug products                                                                         Contact Person: Dennis Hlasta, Ph.D.,
                                                                                                             FDA is committed to the orderly
                                                  nominated for the list of drug products                                                                       Scientific Review Officer, National Institute
                                                                                                          conduct of its advisory committee                     of Biomedical Imaging and Bioengineering,
                                                  that present demonstrable difficulties                  meetings. Please visit our Web site at                National Institutes of Health, 6707
                                                  for compounding. These categories of                    http://www.fda.gov/Advisory                           Democracy Blvd., Bethesda, MD 20892, (301)
                                                  drug products are metered dose inhalers                 Committees/AboutAdvisoryCommittees/                   451–4794, dennis.hlasta@nih.gov.
                                                  and dry powder inhalers. The                            ucm111462.htm for procedures on
                                                  nominators who nominated the category                                                                           Dated: February 4, 2016.
                                                                                                          public conduct during advisory                        David Clary,
                                                  of drugs or specific drug products in the               committee meetings.
                                                  category will be invited to make a short                                                                      Program Analyst, Office of Federal Advisory
                                                                                                             Notice of this meeting is given under
                                                  presentation supporting the nomination.                                                                       Committee Policy.
                                                                                                          the Federal Advisory Committee Act (5
                                                     FDA intends to make background                       U.S.C. app. 2).                                       [FR Doc. 2016–02709 Filed 2–10–16; 8:45 am]
                                                  material available to the public no later                                                                     BILLING CODE 4140–01–P
                                                  than 2 business days before the meeting.                   Dated: February 8, 2016.
                                                  If FDA is unable to post the background                 Jill Hartzler Warner,
                                                  material on its Web site prior to the                   Associate Commissioner for Special Medical            DEPARTMENT OF HEALTH AND
                                                  meeting, the background material will                   Programs.                                             HUMAN SERVICES
                                                  be made publicly available at the                       [FR Doc. 2016–02786 Filed 2–8–16; 4:15 pm]
                                                  location of the advisory committee                      BILLING CODE 4164–01–P
                                                                                                                                                                National Institutes of Health
                                                  meeting, and the background material
                                                                                                                                                                National Institute on Aging; Notice of
                                                  will be posted on FDA’s Web site after
                                                                                                          DEPARTMENT OF HEALTH AND                              Closed Meeting
                                                  the meeting. Background material is
                                                  available at http://www.fda.gov/                        HUMAN SERVICES                                          Pursuant to section 10(d) of the
                                                  AdvisoryCommittees/Calendar/                                                                                  Federal Advisory Committee Act, as
                                                  default.htm. Scroll down to the                         National Institutes of Health                         amended (5 U.S.C. App.), notice is
                                                  appropriate advisory committee meeting                                                                        hereby given of the following meeting.
                                                                                                          National Institute of Biomedical
                                                  link.                                                                                                           The meeting will be closed to the
                                                                                                          Imaging and Bioengineering; Notice of
                                                     Procedure: Interested persons may                                                                          public in accordance with the
                                                                                                          Closed Meetings
                                                  present data, information, or views,                                                                          provisions set forth in sections
                                                  orally or in writing, on issues pending                   Pursuant to section 10(d) of the                    552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
                                                  before the committee. Written                           Federal Advisory Committee Act, as                    as amended. The grant applications and
mstockstill on DSK4VPTVN1PROD with NOTICES




                                                  submissions may be made to the contact                  amended (5 U.S.C. App.), notice is                    the discussions could disclose
                                                  person on or before March 1, 2016. Oral                 hereby given of the following meetings.               confidential trade secrets or commercial
                                                  presentations from the public will be                     The meetings will be closed to the                  property such as patentable material,
                                                  scheduled between approximately 11                      public in accordance with the                         and personal information concerning
                                                  a.m. to 11:15 a.m. and 3:15 p.m. to 3:30                provisions set forth in sections                      individuals associated with the grant
                                                  p.m. on March 8, 2016, and between                      552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,            applications, the disclosure of which
                                                  approximately 11:30 a.m. to 12 noon on                  as amended. The grant applications and                would constitute a clearly unwarranted
                                                  March 9, 2016. Those individuals                        the discussions could disclose                        invasion of personal privacy.


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Document Created: 2016-02-11 00:03:24
Document Modified: 2016-02-11 00:03:24
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
ContactCindy Hong, 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], or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area). A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the Agency's Web site at http://www.fda.gov/ AdvisoryCommittees/default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting.
FR Citation81 FR 7351 

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