81 FR 34344 - Advisory Committee; Psychopharmacologic Drugs Advisory Committee, Renewal
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 104 (May 31, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 104 (May 31, 2016)
| Page Range | 34344-34345 | |
| FR Document | 2016-12637 |
[Federal Register Volume 81, Number 104 (Tuesday, May 31, 2016)] [Notices] [Pages 34344-34345] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-12637] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-N-0001] Advisory Committee; Psychopharmacologic Drugs Advisory Committee, Renewal AGENCY: Food and Drug Administration, HHS. ACTION: Notice; renewal of advisory committee. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing the renewal of the Psychopharmacologic Drugs Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Psychopharmacologic Drugs Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until the June 4, 2018. DATES: Authority for the Psychopharmacologic Drugs Advisory Committee will expire on June 4, 2016, unless the Commissioner formally determines that renewal is in the public interest. FOR FURTHER INFORMATION CONTACT: Kalyani Bhatt, 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, [email protected]. SUPPLEMENTARY INFORMATION: Pursuant to 41 CFR 102-3.65 and approval by the Department of Health and Human Services pursuant to 45 CFR part 11 and by the General Services Administration, FDA is announcing the renewal of the Psychopharmacologic Drugs Advisory Committee. The committee is a discretionary Federal advisory committee established to provide advice to the Commissioner. The Psychopharmacologic Drugs Advisory Committee advises the Commissioner or designee in discharging responsibilities as they relate to helping to ensure safe and effective drugs for human use and, as required, any other product for which the Food and Drug Administration has regulatory responsibility. The Committee reviews and evaluates data concerning the safety and effectiveness of marketed and investigational human drug products for use in the practice of psychiatry and related fields and make appropriate recommendations to the Commissioner of Food and Drugs. The Committee shall consist of a core of nine voting members including the Chair. Members and the Chair are selected by the Commissioner or designee from among authorities knowledgeable in the fields of psychopharmacology, psychiatry, epidemiology or statistics, and related specialties. Members will be invited to serve for overlapping terms of up to 4 years. Almost all non-Federal members of this committee serve as Special Government Employees. The core of voting members may include one technically qualified member, selected by the Commissioner or designee, who is identified with consumer interests and is recommended by either a consortium of consumer- oriented organizations or other interested persons. In addition to the voting members, the Committee may include one non-voting member who is identified with industry interests. Further information regarding the most recent charter and other information can be found at http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/PsychopharmacologicDrugsAdvisoryCommittee/ucm107528.htm or by [[Page 34345]] contacting the Designated Federal Officer (see FOR FURTHER INFORMATION CONTACT). In light of the fact that no change has been made to the committee name or description of duties, no amendment will be made to 21 CFR 14.100. This document is issued under the Federal Advisory Committee Act (5 U.S.C. app.). For general information related to FDA advisory committees, please visit us at http://www.fda.gov/AdvisoryCommittees/default.htm. Dated: May 24, 2016. Jill Hartzler Warner, Associate Commissioner for Special Medical Programs. [FR Doc. 2016-12637 Filed 5-27-16; 8:45 am] BILLING CODE 4164-01-P
![34344 Federal Register / Vol. 81, No. 104 / Tuesday, May 31, 2016 / Notices
expiration date. The new charter will be voting members may include one Committee will expire on June 4, 2016,
in effect until July 9, 2018. technically qualified member, selected unless the Commissioner formally
DATES: Authority for the Allergenic by the Commissioner or designee, who determines that renewal is in the public
Products Advisory Committee will is identified with consumer interests interest.
expire on July 9, 2016, unless the and is recommended by either a FOR FURTHER INFORMATION CONTACT:
Commissioner formally determines that consortium of consumer-oriented Kalyani Bhatt, Center for Drug
renewal is in the public interest. organizations or other interested Evaluation and Research, Food and
FOR FURTHER INFORMATION CONTACT: persons. In addition to the voting Drug Administration, 10903 New
Janie Kim, Division of Scientific members, the Committee may include Hampshire Ave., Bldg. 31, Rm. 2417,
Advisors and Consultants, Center for one non-voting member who is Silver Spring, MD 20993–0002, 301–
Biologics Evaluation and Research, identified with industry interests. 796–9001, PDAC@fda.hhs.gov.
Food and Drug Administration, 10903 Further information regarding the
SUPPLEMENTARY INFORMATION: Pursuant
New Hampshire Ave., Bldg. 71, Rm. most recent charter and other
to 41 CFR 102–3.65 and approval by the
6129, Silver Spring, MD 20993–0002; information can be found at http://
Department of Health and Human
www.fda.gov/AdvisoryCommittees/
301–796–9016, Janie.kim@fda.hhs.gov. Services pursuant to 45 CFR part 11 and
CommitteesMeetingMaterials/
SUPPLEMENTARY INFORMATION: Pursuant by the General Services Administration,
BloodVaccinesandOtherBiologics/
to 41 CFR 102–3.65 and approval by the FDA is announcing the renewal of the
AllergenicProductsAdvisoryCommittee/
Department of Health and Human ucm129360.htm or by contacting the Psychopharmacologic Drugs Advisory
Services pursuant to 45 CFR part 11 and Designated Federal Officer (see FOR Committee. The committee is a
by the General Services Administration, FURTHER INFORMATION CONTACT). In light
discretionary Federal advisory
FDA is announcing the renewal of the of the fact that no change has been made committee established to provide advice
Allergenic Products Advisory to the committee name or description of to the Commissioner. The
Committee (the Committee). The duties, no amendment will be made to Psychopharmacologic Drugs Advisory
Committee is a discretionary Federal 21 CFR 14.100. Committee advises the Commissioner or
advisory committee established to This document is issued under the designee in discharging responsibilities
provide advice to the Commissioner. Federal Advisory Committee Act (5 as they relate to helping to ensure safe
The Committee advises the U.S.C. app.). For general information and effective drugs for human use and,
Commissioner or designee in related to FDA advisory committees, as required, any other product for which
discharging responsibilities as they please visit us at http://www.fda.gov/ the Food and Drug Administration has
relate to helping to ensure safe and AdvisoryCommittees/default.htm. regulatory responsibility. The
effective drugs for human use and, as Committee reviews and evaluates data
Dated: May 24, 2016.
required, any other product for which concerning the safety and effectiveness
Jill Hartzler Warner, of marketed and investigational human
FDA has regulatory responsibility.
The Committee reviews and evaluates Associate Commissioner for Special Medical drug products for use in the practice of
available data concerning the safety, Programs.
psychiatry and related fields and make
effectiveness, and adequacy of labeling [FR Doc. 2016–12636 Filed 5–27–16; 8:45 am] appropriate recommendations to the
of marketed and investigational BILLING CODE 4164–01–P Commissioner of Food and Drugs.
allergenic biological products or The Committee shall consist of a core
materials that are administered to of nine voting members including the
humans for the diagnosis, prevention, or DEPARTMENT OF HEALTH AND Chair. Members and the Chair are
treatment of allergies and allergic HUMAN SERVICES selected by the Commissioner or
disease, and makes appropriate Food and Drug Administration designee from among authorities
recommendations to the Commissioner knowledgeable in the fields of
of its findings regarding the affirmation [Docket No. FDA–2016–N–0001] psychopharmacology, psychiatry,
or revocation of biological product epidemiology or statistics, and related
licenses, on the safety, effectiveness, Advisory Committee; specialties. Members will be invited to
and labeling of the products, on clinical Psychopharmacologic Drugs Advisory serve for overlapping terms of up to 4
and laboratory studies of such products, Committee, Renewal years. Almost all non-Federal members
on amendments or revisions to AGENCY: Food and Drug Administration, of this committee serve as Special
regulations governing the manufacture, HHS. Government Employees. The core of
testing, and licensing of allergenic ACTION:Notice; renewal of advisory voting members may include one
biological products, and on the quality committee. technically qualified member, selected
and relevance of FDA’s research by the Commissioner or designee, who
programs which provide the scientific SUMMARY: The Food and Drug is identified with consumer interests
support for regulating these agents. Administration (FDA) is announcing the and is recommended by either a
The Committee shall consist of a core renewal of the Psychopharmacologic consortium of consumer-oriented
of nine voting members including the Drugs Advisory Committee by the organizations or other interested
Chair. Members and the Chair are Commissioner of Food and Drugs (the persons. In addition to the voting
selected by the Commissioner or Commissioner). The Commissioner has members, the Committee may include
designee from among authorities determined that it is in the public one non-voting member who is
knowledgeable in the fields of allergy, interest to renew the identified with industry interests.
sradovich on DSK3TPTVN1PROD with NOTICES
immunology, pediatrics, internal Psychopharmacologic Drugs Advisory Further information regarding the
medicine, biochemistry, and related Committee for an additional 2 years most recent charter and other
specialties. Members will be invited to beyond the charter expiration date. The information can be found at http://
serve for overlapping terms of up to 4 new charter will be in effect until the www.fda.gov/AdvisoryCommittees/
years. Almost all non-Federal members June 4, 2018. CommitteesMeetingMaterials/Drugs/
of this committee serve as Special DATES: Authority for the PsychopharmacologicDrugsAdvisory
Government Employees. The core of Psychopharmacologic Drugs Advisory Committee/ucm107528.htm or by
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![Federal Register / Vol. 81, No. 104 / Tuesday, May 31, 2016 / Notices 34345
contacting the Designated Federal data integrity. Standards regarding except for information submitted,
Officer (see FOR FURTHER INFORMATION electronic records and essential marked and identified, as confidential,
CONTACT). In light of the fact that no documents intended to increase clinical if submitted as detailed in
change has been made to the committee trial quality and efficiency have also ‘‘Instructions.’’
name or description of duties, no been updated. The E6(R2) draft Instructions: All submissions received
amendment will be made to 21 CFR guidance was intended to improve must include the Docket No. FDA–
14.100. clinical trial quality and efficiency 2015–D–3327 for ‘‘Agency Information
This document is issued under the while maintaining human subject Collection Activities; Proposed
Federal Advisory Committee Act (5 protection. This notice solicits Collection; Comment Request; E6(R2)
U.S.C. app.). For general information comments on the collection of Good Clinical Practice; International
related to FDA advisory committees, information in the draft guidance Council for Harmonisation.’’ Received
please visit us at http://www.fda.gov/ concerning the development of a system comments will be placed in the docket
AdvisoryCommittees/default.htm. to manage quality, as well as and, except for those submitted as
Dated: May 24, 2016. information to include in a clinical ‘‘Confidential Submissions,’’ publicly
Jill Hartzler Warner, study report about the quality viewable at http://www.regulations.gov
Associate Commissioner for Special Medical management approach. or at the Division of Dockets
Programs. DATES: Submit either electronic or Management between 9 a.m. and 4 p.m.,
[FR Doc. 2016–12637 Filed 5–27–16; 8:45 am] written comments on the collection of Monday through Friday.
BILLING CODE 4164–01–P information by August 1, 2016 on the • Confidential Submissions—To
‘‘ADDENDUM’’ sections of the E6(R2) submit a comment with confidential
draft guidance. information that you do not wish to be
DEPARTMENT OF HEALTH AND ADDRESSES: You may submit comments
made publicly available, submit your
HUMAN SERVICES as follows: comments only as a written/paper
submission. You should submit two
Food and Drug Administration Electronic Submissions copies total. One copy will include the
[Docket No. FDA–2015–D–3327] Submit electronic comments in the information you claim to be confidential
following way: with a heading or cover note that states
Agency Information Collection • Federal eRulemaking Portal: http:// ‘‘THIS DOCUMENT CONTAINS
Activities; Proposed Collection; www.regulations.gov. Follow the CONFIDENTIAL INFORMATION.’’ The
Comment Request; E6(R2) Good instructions for submitting comments. Agency will review this copy, including
Clinical Practice; International Council Comments submitted electronically, the claimed confidential information, in
for Harmonisation including attachments, to http:// its consideration of comments. The
www.regulations.gov will be posted to second copy, which will have the
AGENCY: Food and Drug Administration, claimed confidential information
HHS. the docket unchanged. Because your
comment will be made public, you are redacted/blacked out, will be available
ACTION: Notice. for public viewing and posted on http://
solely responsible for ensuring that your
SUMMARY: The Food and Drug comment does not include any www.regulations.gov. Submit both
Administration (FDA, we, or the confidential information that you or a copies to the Division of Dockets
Agency) is announcing an opportunity third party may not wish to be posted, Management. If you do not wish your
for public comment on the proposed such as medical information, your or name and contact information to be
collection of certain information by the anyone else’s Social Security number, or made publicly available, you can
Agency. Under the Paperwork confidential business information, such provide this information on the cover
Reduction Act of 1995 (the PRA), as a manufacturing process. Please note sheet and not in the body of your
Federal Agencies are required to publish that if you include your name, contact comments and you must identify this
notice in the Federal Register information, or other information that information as ‘‘confidential.’’ Any
concerning each proposed collection of identifies you in the body of your information marked as ‘‘confidential’’
information and to allow 60 days for comments, that information will be will not be disclosed except in
public comment in response to the posted on http://www.regulations.gov. accordance with 21 CFR 10.20 and other
notice. This notice solicits comments on • If you want to submit a comment applicable disclosure law. For more
the collections of information marked as with confidential information that you information about FDA’s posting of
‘‘ADDENDUM’’ in the draft guidance do not wish to be made available to the comments to public dockets, see 80 FR
entitled ‘‘E6(R2) Good Clinical Practice’’ public, submit the comment as a 56469, September 18, 2015, or access
(E6(R2) draft guidance). The E6(R2) written/paper submission and in the the information at: http://www.fda.gov/
draft guidance was prepared under the manner detailed (see ‘‘Written/Paper regulatoryinformation/dockets/
auspices of the International Council for Submission’’ and ‘‘Instructions’’). default.htm.
Harmonisation of Technical Docket: For access to the docket to
Requirements for Registration of Written/Paper Submissions read background documents or the
Pharmaceuticals for Human Use (ICH). Submit written/paper submissions as electronic and written/paper comments
The E6(R2) draft guidance amends the follows: received, go to http://
guidance entitled ‘‘E6 Good Clinical • Mail/Hand delivery/Courier (for www.regulations.gov and insert the
Practice: Consolidated Guidance’’ written/paper submissions): Division of docket number, found in brackets in the
sradovich on DSK3TPTVN1PROD with NOTICES
(E6(R1) consolidated guidance), issued Dockets Management (HFA–305), Food heading of this document, into the
in April 1996, to encourage and Drug Administration, 5630 Fishers ‘‘Search’’ box and follow the prompts
implementation of improved and more Lane, Rm. 1061, Rockville, MD 20852. and/or go to the Division of Dockets
efficient approaches to clinical trial • For written/paper comments Management, 5630 Fishers Lane, Rm.
design, conduct, oversight, recording, submitted to the Division of Dockets 1061, Rockville, MD 20852.
and reporting while continuing to Management, FDA will post your FOR FURTHER INFORMATION CONTACT: FDA
ensure human subject protection and comment, as well as any attachments, PRA Staff, Office of Operations, Food
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Document Created: 2016-05-28 03:57:31
Document Modified: 2016-05-28 03:57:31
| 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; renewal of advisory committee. | |
| Dates | Authority for the Psychopharmacologic Drugs Advisory Committee will expire on June 4, 2016, unless the Commissioner formally determines that renewal is in the public interest. | |
| Contact | Kalyani Bhatt, 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, [email protected] | |
| FR Citation | 81 FR 34344 |
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