81_FR_2885 81 FR 2874 - Modified Release Veterinary Parenteral Dosage Forms: Development, Evaluation, and Establishment of Specifications; Draft Guidance for Industry; Availability

81 FR 2874 - Modified Release Veterinary Parenteral Dosage Forms: Development, Evaluation, and Establishment of Specifications; Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 11 (January 19, 2016)

Page Range2874-2875
FR Document2016-00822

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry (GFI) #238 entitled ``Modified Release Veterinary Parenteral Dosage Forms: Development, Evaluation, and Establishment of Specifications.'' This draft guidance provides recommendations on the submission of chemistry, manufacturing, and controls (CMC) and pharmacokinetic information, as well as procedures to follow, to support the approval of modified release parenteral drug products intended for use in veterinary species. This draft guidance is applicable to both new animal drug applications (NADAs) and abbreviated new animal drug application (ANADAs) products.

Federal Register, Volume 81 Issue 11 (Tuesday, January 19, 2016)
[Federal Register Volume 81, Number 11 (Tuesday, January 19, 2016)]
[Notices]
[Pages 2874-2875]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-00822]



[[Page 2874]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-4563]


Modified Release Veterinary Parenteral Dosage Forms: Development, 
Evaluation, and Establishment of Specifications; Draft Guidance for 
Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance for industry (GFI) #238 entitled 
``Modified Release Veterinary Parenteral Dosage Forms: Development, 
Evaluation, and Establishment of Specifications.'' This draft guidance 
provides recommendations on the submission of chemistry, manufacturing, 
and controls (CMC) and pharmacokinetic information, as well as 
procedures to follow, to support the approval of modified release 
parenteral drug products intended for use in veterinary species. This 
draft guidance is applicable to both new animal drug applications 
(NADAs) and abbreviated new animal drug application (ANADAs) products.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment on this 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by March 21, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
[FDA-2015-N-4563] for Modified Release Veterinary Parenteral Dosage 
Forms: Development, Evaluation, and Establishment of Specifications. 
Received comments will be placed in the docket and, except for those 
submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 
a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION''. The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of the guidance to the 
Policy and Regulations Staff (HFV-6), Center for Veterinary Medicine, 
Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855. 
Send one self-addressed adhesive label to assist that office in 
processing your requests. See the SUPPLEMENTARY INFORMATION section for 
electronic access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Gregory Hunter, Center for Veterinary 
Medicine (HFV-142), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 240-402-0675, email: [email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of draft GFI #238 entitled 
``Modified Release Veterinary Parenteral Dosage Forms: Development, 
Evaluation, and Establishment of Specifications.'' This draft guidance 
provides recommendations on the submission of chemistry, manufacturing, 
and controls (CMC) and pharmacokinetic information, as well as 
procedures to follow, to support the approval of modified release 
parenteral drug products intended for use in veterinary species. This 
draft guidance is applicable to both new animal drug applications 
(NADAs) and abbreviated new animal drug application (ANADAs) products.

II. Significance of Guidance

    This level 1 draft guidance is being issued consistent with FDA's 
good guidance practices regulation (21 CFR 10.115). The draft guidance, 
when finalized, will represent the current thinking of FDA on 
``Modified Release Veterinary Parenteral Dosage Forms:

[[Page 2875]]

Development, Evaluation, and Establishment of Specifications.'' It does 
not establish any rights for any person and is not binding on FDA or 
the public. You can use an alternative approach if it satisfies the 
requirements of the applicable statutes and regulations.

III. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information in 21 CFR part 514 have been approved under 
OMB control number 0910-0032; the collections of information in section 
512(n)(1) of the FD&C Act (21 U.S.C. 360k) have been approved under OMB 
control number 0910-0669.

IV. Electronic Access

    Persons with access to the Internet may obtain the draft guidance 
at either http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm or http://www.regulations.gov.

    Dated: January 13, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-00822 Filed 1-15-16; 8:45 am]
 BILLING CODE 4164-01-P



                                                    2874                           Federal Register / Vol. 81, No. 11 / Tuesday, January 19, 2016 / Notices

                                                    DEPARTMENT OF HEALTH AND                                 information, or other information that                 information marked as ‘‘confidential’’
                                                    HUMAN SERVICES                                           identifies you in the body of your                     will not be disclosed except in
                                                                                                             comments, that information will be                     accordance with 21 CFR 10.20 and other
                                                    Food and Drug Administration                             posted on http://www.regulations.gov.                  applicable disclosure law. For more
                                                                                                               • If you want to submit a comment                    information about FDA’s posting of
                                                    [Docket No. FDA–2015–N–4563]
                                                                                                             with confidential information that you                 comments to public dockets, see 80 FR
                                                    Modified Release Veterinary Parenteral                   do not wish to be made available to the                56469, September 18, 2015, or access
                                                    Dosage Forms: Development,                               public, submit the comment as a                        the information at: http://www.fda.gov/
                                                    Evaluation, and Establishment of                         written/paper submission and in the                    regulatoryinformation/dockets/
                                                    Specifications; Draft Guidance for                       manner detailed (see ‘‘Written/Paper                   default.htm.
                                                    Industry; Availability                                   Submissions’’ and ‘‘Instructions’’).                      Docket: For access to the docket to
                                                                                                             Written/Paper Submissions                              read background documents or the
                                                    AGENCY:    Food and Drug Administration,                                                                        electronic and written/paper comments
                                                    HHS.                                                        Submit written/paper submissions as                 received, go to http://
                                                    ACTION:   Notice.                                        follows:                                               www.regulations.gov and insert the
                                                                                                                • Mail/Hand delivery/Courier (for
                                                                                                                                                                    docket number, found in brackets in the
                                                    SUMMARY:   The Food and Drug                             written/paper submissions): Division of
                                                                                                                                                                    heading of this document, into the
                                                    Administration (FDA) is announcing the                   Dockets Management (HFA–305), Food
                                                                                                                                                                    ‘‘Search’’ box and follow the prompts
                                                    availability of a draft guidance for                     and Drug Administration, 5630 Fishers
                                                                                                                                                                    and/or go to the Division of Dockets
                                                    industry (GFI) #238 entitled ‘‘Modified                  Lane, Rm. 1061, Rockville, MD 20852.
                                                                                                                • For written/paper comments                        Management, 5630 Fishers Lane, Rm.
                                                    Release Veterinary Parenteral Dosage                                                                            1061, Rockville, MD 20852.
                                                    Forms: Development, Evaluation, and                      submitted to the Division of Dockets
                                                                                                             Management, FDA will post your                            Submit written requests for single
                                                    Establishment of Specifications.’’ This                                                                         copies of the guidance to the Policy and
                                                    draft guidance provides                                  comment, as well as any attachments,
                                                                                                             except for information submitted,                      Regulations Staff (HFV–6), Center for
                                                    recommendations on the submission of                                                                            Veterinary Medicine, Food and Drug
                                                    chemistry, manufacturing, and controls                   marked and identified, as confidential,
                                                                                                             if submitted as detailed in                            Administration, 7519 Standish Pl.,
                                                    (CMC) and pharmacokinetic                                                                                       Rockville, MD 20855. Send one self-
                                                    information, as well as procedures to                    ‘‘Instructions.’’
                                                                                                                Instructions: All submissions received              addressed adhesive label to assist that
                                                    follow, to support the approval of                                                                              office in processing your requests. See
                                                    modified release parenteral drug                         must include the Docket No. [FDA–
                                                                                                             2015–N–4563] for Modified Release                      the SUPPLEMENTARY INFORMATION section
                                                    products intended for use in veterinary                                                                         for electronic access to the draft
                                                    species. This draft guidance is                          Veterinary Parenteral Dosage Forms:
                                                                                                             Development, Evaluation, and                           guidance document.
                                                    applicable to both new animal drug
                                                                                                             Establishment of Specifications.                       FOR FURTHER INFORMATION CONTACT:
                                                    applications (NADAs) and abbreviated
                                                                                                             Received comments will be placed in                    Gregory Hunter, Center for Veterinary
                                                    new animal drug application (ANADAs)
                                                                                                             the docket and, except for those                       Medicine (HFV–142), Food and Drug
                                                    products.
                                                                                                             submitted as ‘‘Confidential                            Administration, 7500 Standish Pl.,
                                                    DATES: Although you can comment on                                                                              Rockville, MD 20855, 240–402–0675,
                                                                                                             Submissions,’’ publicly viewable at
                                                    any guidance at any time (see 21 CFR                     http://www.regulations.gov or at the                   email: Gregory.Hunter@fda.hhs.gov.
                                                    10.115(g)(5)), to ensure that the Agency                 Division of Dockets Management                         SUPPLEMENTARY INFORMATION:
                                                    considers your comment on this draft                     between 9 a.m. and 4 p.m., Monday
                                                    guidance before it begins work on the                    through Friday.                                        I. Background
                                                    final version of the guidance, submit                       • Confidential Submissions—To                         FDA is announcing the availability of
                                                    either electronic or written comments                    submit a comment with confidential                     draft GFI #238 entitled ‘‘Modified
                                                    on the draft guidance by March 21,                       information that you do not wish to be                 Release Veterinary Parenteral Dosage
                                                    2016.                                                    made publicly available, submit your                   Forms: Development, Evaluation, and
                                                    ADDRESSES:       You may submit comments                 comments only as a written/paper                       Establishment of Specifications.’’ This
                                                    as follows:                                              submission. You should submit two                      draft guidance provides
                                                                                                             copies total. One copy will include the                recommendations on the submission of
                                                    Electronic Submissions                                   information you claim to be confidential               chemistry, manufacturing, and controls
                                                      Submit electronic comments in the                      with a heading or cover note that states               (CMC) and pharmacokinetic
                                                    following way:                                           ‘‘THIS DOCUMENT CONTAINS                               information, as well as procedures to
                                                      • Federal eRulemaking Portal: http://                  CONFIDENTIAL INFORMATION’’. The                        follow, to support the approval of
                                                    www.regulations.gov. Follow the                          Agency will review this copy, including                modified release parenteral drug
                                                    instructions for submitting comments.                    the claimed confidential information, in               products intended for use in veterinary
                                                    Comments submitted electronically,                       its consideration of comments. The                     species. This draft guidance is
                                                    including attachments, to http://                        second copy, which will have the                       applicable to both new animal drug
                                                    www.regulations.gov will be posted to                    claimed confidential information                       applications (NADAs) and abbreviated
                                                    the docket unchanged. Because your                       redacted/blacked out, will be available                new animal drug application (ANADAs)
                                                    comment will be made public, you are                     for public viewing and posted on                       products.
                                                    solely responsible for ensuring that your                http://www.regulations.gov. Submit
asabaliauskas on DSK5VPTVN1PROD with NOTICES




                                                    comment does not include any                             both copies to the Division of Dockets                 II. Significance of Guidance
                                                    confidential information that you or a                   Management. If you do not wish your                       This level 1 draft guidance is being
                                                    third party may not wish to be posted,                   name and contact information to be                     issued consistent with FDA’s good
                                                    such as medical information, your or                     made publicly available, you can                       guidance practices regulation (21 CFR
                                                    anyone else’s Social Security number, or                 provide this information on the cover                  10.115). The draft guidance, when
                                                    confidential business information, such                  sheet and not in the body of your                      finalized, will represent the current
                                                    as a manufacturing process. Please note                  comments and you must identify this                    thinking of FDA on ‘‘Modified Release
                                                    that if you include your name, contact                   information as ‘‘confidential.’’ Any                   Veterinary Parenteral Dosage Forms:


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                                                                                  Federal Register / Vol. 81, No. 11 / Tuesday, January 19, 2016 / Notices                                              2875

                                                    Development, Evaluation, and                              Agenda: To review and evaluate grant                   Name of Committee: Center for Scientific
                                                    Establishment of Specifications.’’ It does              applications.                                          Review Special Emphasis Panel; PAR13–213:
                                                    not establish any rights for any person                   Place: National Institutes of Health, 6701           Outcome Measures for Use in Treatment
                                                                                                            Rockledge Drive, Bethesda, MD 20892,                   Trials for Individuals with Intellectual and
                                                    and is not binding on FDA or the public.                                                                       Developmental Disabilities.
                                                                                                            (Virtual Meeting).
                                                    You can use an alternative approach if                    Contact Person: John Bishop, Ph.D.,                    Date: February 11, 2016.
                                                    it satisfies the requirements of the                    Scientific Review Officer, Center for                    Time: 8:00 a.m. to 11:00 p.m.
                                                    applicable statutes and regulations.                    Scientific Review, National Institutes of                Agenda: To review and evaluate grant
                                                                                                            Health, 6701 Rockledge Drive, Room 5182,               applications.
                                                    III. Paperwork Reduction Act of 1995                    MSC 7844, Bethesda, MD 20892, (301) 408–                 Place: National Institutes of Health, 6701
                                                       This draft guidance refers to                        9664, bishopj@csr.nih.gov.                             Rockledge Drive, Bethesda, MD 20892,
                                                    previously approved collections of                        Name of Committee: Healthcare Delivery               (Virtual Meeting).
                                                    information found in FDA regulations.                   and Methodologies Integrated Review Group;               Contact Person: Jane A. Doussard-
                                                                                                            Biomedical Computing and Health                        Roosevelt, Ph.D., Scientific Review Officer,
                                                    These collections of information are
                                                                                                            Informatics Study Section.                             Center for Scientific Review, National
                                                    subject to review by the Office of                                                                             Institutes of Health, 6701 Rockledge Drive,
                                                    Management and Budget (OMB) under                         Date: February 5, 2016.
                                                                                                              Time: 8:00 a.m. to 5:00 p.m.                         Room 3184, MSC 7848, Bethesda, MD 20892,
                                                    the Paperwork Reduction Act of 1995                                                                            (301) 435–4445, doussarj@csr.nih.gov.
                                                                                                              Agenda: To review and evaluate grant
                                                    (44 U.S.C. 3501–3520). The collections                  applications.                                            Name of Committee: Risk, Prevention and
                                                    of information in 21 CFR part 514 have                    Place: Mayflower Park Hotel, 405 Olive               Health Behavior Integrated Review Group;
                                                    been approved under OMB control                         Way, Seattle, WA 98101.                                Social Psychology, Personality and
                                                    number 0910–0032; the collections of                      Contact Person: Peter J. Kozel, Ph.D.,               Interpersonal Processes Study Section.
                                                    information in section 512(n)(1) of the                 Scientific Review Officer, Center for                    Date: February 11–12, 2016.
                                                    FD&C Act (21 U.S.C. 360k) have been                     Scientific Review, National Institutes of                Time: 8:00 a.m. to 5:00 p.m.
                                                                                                            Health, 6701 Rockledge Drive, Room 3139,                 Agenda: To review and evaluate grant
                                                    approved under OMB control number                                                                              applications.
                                                    0910–0669.                                              Bethesda, MD 20892, 301–435–1116, kozelp@
                                                                                                            mail.nih.gov.                                            Place: The Westgate Hotel, 1055 Second
                                                    IV. Electronic Access                                                                                          Avenue, San Diego, CA 92101.
                                                                                                              Name of Committee: Bioengineering
                                                                                                                                                                     Contact Person: Marc Boulay, Ph.D.,
                                                      Persons with access to the Internet                   Sciences & Technologies Integrated Review
                                                                                                                                                                   Scientific Review Officer, Center for
                                                    may obtain the draft guidance at either                 Group; Instrumentation and Systems
                                                                                                                                                                   Scientific Review, National Institutes of
                                                                                                            Development Study Section.
                                                    http://www.fda.gov/AnimalVeterinary/                      Date: February 10–11, 2016.
                                                                                                                                                                   Health, 6701 Rockledge Drive, Room 3110,
                                                    GuidanceComplianceEnforcement/                                                                                 MSC 7808, Bethesda, MD 20892, (301) 300–
                                                                                                              Time: 8:00 a.m. to 5:00 p.m.
                                                    GuidanceforIndustry/default.htm or                                                                             6541, boulaymg@csr.nih.gov.
                                                                                                              Agenda: To review and evaluate grant                   Name of Committee: Center for Scientific
                                                    http://www.regulations.gov.                             applications.                                          Review Special Emphasis Panel; Nursing and
                                                      Dated: January 13, 2016.                                Place: Best Western Tuscan Inn, 425 North            Related Clinical Sciences Overflow.
                                                                                                            Point Street, San Francisco, CA 94133.                   Date: February 11–12, 2016.
                                                    Leslie Kux,
                                                                                                              Contact Person: Kathryn Kalasinsky, Ph.D.,             Time: 8:00 a.m. to 5:00 p.m.
                                                    Associate Commissioner for Policy.                      Scientific Review Officer, Center for                    Agenda: To review and evaluate grant
                                                    [FR Doc. 2016–00822 Filed 1–15–16; 8:45 am]             Scientific Review, National Institutes of              applications.
                                                    BILLING CODE 4164–01–P                                  Health, 6701 Rockledge Drive, Room 5158                  Place: The St. Regis Washington DC, 923
                                                                                                            MSC 7806, Bethesda, MD 20892, 301–402–                 16th Street N.W., Washington, DC 20006.
                                                                                                            1074, kalasinskyks@mail.nih.gov.                         Contact Person: Martha L. Hare, Ph.D., RN,
                                                    DEPARTMENT OF HEALTH AND                                  Name of Committee: Surgical Sciences,                Scientific Review Officer, Center for
                                                    HUMAN SERVICES                                          Biomedical Imaging and Bioengineering                  Scientific Review, National Institutes of
                                                                                                            Integrated Review Group; Surgery,                      Health, 6701 Rockledge Drive, Room 3154,
                                                    National Institutes of Health                           Anesthesiology and Trauma Study Section.               Bethesda, MD 20892, (301) 451–8504,
                                                                                                              Date: February 10–11, 2016.                          harem@mail.nih.gov.
                                                    Center for Scientific Review; Notice of                   Time: 8:00 a.m. to 5:00 p.m.                           Name of Committee: Center for Scientific
                                                    Closed Meetings                                           Agenda: To review and evaluate grant                 Review Special Emphasis Panel; PAR13–137:
                                                                                                            applications.                                          Bioengineering Research.
                                                      Pursuant to section 10(d) of the                        Place: Hilton San Diego Mission Valley,                Date: February 11, 2016.
                                                    Federal Advisory Committee Act, as                      901 Camino Del Rio South, San Diego, CA                  Time: 8:00 a.m. to 9:00 a.m.
                                                    amended (5 U.S.C. App.), notice is                      92108.                                                   Agenda: To review and evaluate grant
                                                    hereby given of the following meetings.                   Contact Person: Weihua Luo, MD, Ph.D.,               applications.
                                                                                                            Scientific Review Officer, Center for                    Place: Renaissance Washington DC,
                                                      The meetings will be closed to the
                                                                                                            Scientific Review, National Institutes of              Dupont Circle, 1143 New Hampshire Avenue
                                                    public in accordance with the                           Health, 6701 Rockledge Drive, Room 5114,               N.W., Washington, DC 20037.
                                                    provisions set forth in sections                        MSC 7854, Bethesda, MD 20892, (301) 435–                 Contact Person: Yvonne Bennett, Ph.D.,
                                                    552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,              1170, luow@csr.nih.gov.                                Scientific Review Officer, Center for
                                                    as amended. The grant applications and                    Name of Committee: Biobehavioral and                 Scientific Review, National Institutes of
                                                    the discussions could disclose                          Behavioral Processes Integrated Review                 Health, 6701 Rockledge Drive, Room 5199,
                                                    confidential trade secrets or commercial                Group; Motor Function, Speech and                      MSC 7846, Bethesda, MD 20892, 301–379–
                                                    property such as patentable material,                   Rehabilitation Study Section.                          3793, bennetty@csr.nih.gov.
                                                    and personal information concerning                       Date: February 11–12, 2016.                            Name of Committee: Center for Scientific
                                                                                                              Time: 8:00 a.m. to 6:00 p.m.                         Review Special Emphasis Panel;
asabaliauskas on DSK5VPTVN1PROD with NOTICES




                                                    individuals associated with the grant
                                                    applications, the disclosure of which                     Agenda: To review and evaluate grant                 Interventions to Prevent and Treat
                                                                                                            applications.                                          Addictions.
                                                    would constitute a clearly unwarranted
                                                                                                              Place: Pier 2620 Hotel, 2620 Jones Street,             Date: February 11, 2016.
                                                    invasion of personal privacy.                           San Francisco, CA 94133.                                 Time: 11:00 a.m. to 12:00 p.m.
                                                      Name of Committee: Center for Scientific                Contact Person: Biao Tian, Ph.D., Scientific           Agenda: To review and evaluate grant
                                                    Review Special Emphasis Panel; Member                   Review Officer, Center for Scientific Review,          applications.
                                                    Conflict: Auditory Neuroscience.                        National Institutes of Health, 6701 Rockledge            Place: Renaissance Mayflower Hotel, 1127
                                                      Date: February 2–3, 2016.                             Drive, Room 3166, MSC 7848, Bethesda, MD               Connecticut Avenue N.W., Washington, DC
                                                      Time: 8:00 a.m. to 6:00 p.m.                          20892, 301–402–4411, tianbi@csr.nih.gov.               20036.



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Document Created: 2016-01-16 01:10:45
Document Modified: 2016-01-16 01:10:45
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.
DatesAlthough you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by March 21, 2016.
ContactGregory Hunter, Center for Veterinary Medicine (HFV-142), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-402-0675, email: [email protected]
FR Citation81 FR 2874 

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