83 FR 51464 - Advisory Committee; Dermatologic and Ophthalmic Drugs Advisory Committee, Renewal
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 197 (October 11, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 197 (October 11, 2018)
| Page Range | 51464-51464 | |
| FR Document | 2018-22183 |
[Federal Register Volume 83, Number 197 (Thursday, October 11, 2018)] [Notices] [Page 51464] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-22183] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-N-3343] Advisory Committee; Dermatologic and Ophthalmic 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 Dermatologic and Ophthalmic 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 Dermatologic and Ophthalmic Drugs Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until October 7, 2020. DATES: Authority for the Dermatologic and Ophthalmic Drugs Advisory Committee will expire on October 7, 2018, unless the Commissioner formally determines that renewal is in the public interest. FOR FURTHER INFORMATION CONTACT: LaToya Bonner, 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: DODAC@fda.hhs.gov. 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 Dermatologic and Ophthalmic Drugs Advisory Committee (the Committee). The Committee is a discretionary Federal advisory committee established to provide advice to the Commissioner. The 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 FDA has regulatory responsibility. The Committee reviews and evaluates available data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of dermatologic and ophthalmic disorders and makes appropriate recommendations to the Commissioner. The Committee shall consist of a core of nine voting members including two Chairpersons. Members and the Chairpersons are selected by the Commissioner or designee from among authorities knowledgeable in the fields of dermatology, ophthalmology, internal medicine, pathology, immunology, epidemiology or statistics, and other related professions. 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 https://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/DermatologicandOphthalmicDrugsAdvisoryCommittee/ucm094782.htm or by 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 check https://www.fda.gov/AdvisoryCommittees/default.htm. Dated: October 4, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-22183 Filed 10-10-18; 8:45 am] BILLING CODE 4164-01-P
![51464 Federal Register / Vol. 83, No. 197 / Thursday, October 11, 2018 / Notices
Total Annual Responses: 166,140. Silver Spring, MD 20993–0002, 301– description of duties, no amendment
Total Burden Hours: 782,520. 796–9001, email: DODAC@fda.hhs.gov. will be made to 21 CFR 14.100.
Affected Public: Businesses or other SUPPLEMENTARY INFORMATION: Pursuant This document is issued under the
for-profit and not-for-profit institutions. to 41 CFR 102–3.65 and approval by the Federal Advisory Committee Act (5
Frequency: Variable, depending on Department of Health and Human U.S.C. app.). For general information
the collection. Services pursuant to 45 CFR part 11 and related to FDA advisory committees,
Obtaining Copies: Requesters may by the General Services Administration, please check https://www.fda.gov/
obtain a copy of the information FDA is announcing the renewal of the AdvisoryCommittees/default.htm.
collection documents from the General Dermatologic and Ophthalmic Drugs Dated: October 4, 2018.
Services Administration, Regulatory Advisory Committee (the Committee). Leslie Kux,
Secretariat Division (MVCB), 1800 F The Committee is a discretionary Associate Commissioner for Policy.
Street NW, Washington, DC 20405, Federal advisory committee established
[FR Doc. 2018–22183 Filed 10–10–18; 8:45 am]
telephone 202–501–4755. Please cite to provide advice to the Commissioner.
BILLING CODE 4164–01–P
OMB Control No. 9000–0107, Federal The Committee advises the
Acquisition Regulation Part 23 Commissioner or designee in
Requirements, in all correspondence. discharging responsibilities as they
DEPARTMENT OF HEALTH AND
relate to helping to ensure safe and
Dated: October 3, 2018. HUMAN SERVICES
effective drugs for human use and, as
Janet Fry,
required, any other product for which Food and Drug Administration
Director, Federal Acquisition Policy Division, FDA has regulatory responsibility.
Office of Governmentwide Acquisition Policy, The Committee reviews and evaluates
Office of Acquisition Policy, Office of [Docket Nos. FDA–2018–N–0341; FDA–
available data concerning the safety and 2012–N–0115; FDA–2018–N–1011; FDA–
Governmentwide Policy.
effectiveness of marketed and 2010–N–0110; FDA–2012–N–0547; FDA–
[FR Doc. 2018–22030 Filed 10–10–18; 8:45 am]
investigational human drug products for 2014–N–2347; FDA–2016–D–2285; FDA–
BILLING CODE 6820–EP–P
use in the treatment of dermatologic and 2016–D–1307; FDA–2016–D–4318; FDA–
ophthalmic disorders and makes 2016–N–0407; and FDA–2018–N–0270]
appropriate recommendations to the
DEPARTMENT OF HEALTH AND Commissioner. Agency Information Collection
HUMAN SERVICES The Committee shall consist of a core Activities; Announcement of Office of
of nine voting members including two Management and Budget Approvals
Food and Drug Administration Chairpersons. Members and the AGENCY: Food and Drug Administration,
[Docket No. FDA–2018–N–3343] Chairpersons are selected by the HHS.
Commissioner or designee from among
Advisory Committee; Dermatologic ACTION: Notice.
authorities knowledgeable in the fields
and Ophthalmic Drugs Advisory of dermatology, ophthalmology, internal SUMMARY: The Food and Drug
Committee, Renewal medicine, pathology, immunology, Administration (FDA) is publishing a
epidemiology or statistics, and other list of information collections that have
AGENCY: Food and Drug Administration,
related professions. Members will be been approved by the Office of
HHS.
invited to serve for overlapping terms of Management and Budget (OMB) under
ACTION:Notice; renewal of advisory up to 4 years. Almost all non-Federal the Paperwork Reduction Act of 1995.
committee. members of this committee serve as FOR FURTHER INFORMATION CONTACT: Ila
SUMMARY: The Food and Drug Special Government Employees. The S. Mizrachi, Office of Operations, Food
Administration (FDA) is announcing the core of voting members may include one and Drug Administration, Three White
renewal of the Dermatologic and technically qualified member, selected Flint North, 10A–12M, 11601
Ophthalmic Drugs Advisory Committee by the Commissioner or designee, who Landsdown St., North Bethesda, MD
by the Commissioner of Food and Drugs is identified with consumer interests 20852, 301–796–7726, PRAStaff@
(the Commissioner). The Commissioner and is recommended by either a fda.hhs.gov.
has determined that it is in the public consortium of consumer-oriented
organizations or other interested SUPPLEMENTARY INFORMATION: The
interest to renew the Dermatologic and following is a list of FDA information
Ophthalmic Drugs Advisory Committee persons. In addition to the voting
members, the Committee may include collections recently approved by OMB
for an additional 2 years beyond the under section 3507 of the Paperwork
charter expiration date. The new charter one non-voting member who is
identified with industry interests. Reduction Act of 1995 (44 U.S.C. 3507).
will be in effect until October 7, 2020. The OMB control number and
Further information regarding the
DATES: Authority for the Dermatologic most recent charter and other expiration date of OMB approval for
and Ophthalmic Drugs Advisory information can be found at https:// each information collection are shown
Committee will expire on October 7, www.fda.gov/AdvisoryCommittees/ in table 1. Copies of the supporting
2018, unless the Commissioner formally CommitteesMeetingMaterials/Drugs/ statements for the information
determines that renewal is in the public DermatologicandOphthalmic collections are available on the internet
interest. DrugsAdvisoryCommittee/ at https://www.reginfo.gov/public/do/
FOR FURTHER INFORMATION CONTACT: ucm094782.htm or by contacting the PRAMain. An Agency may not conduct
khammond on DSK30JT082PROD with NOTICES
LaToya Bonner, Center for Drug Designated Federal Officer (see FOR or sponsor, and a person is not required
Evaluation and Research, Food and FURTHER INFORMATION CONTACT). to respond to, a collection of
Drug Administration, 10903 New In light of the fact that no change has information unless it displays a
Hampshire Ave., Bldg. 31, Rm. 2417, been made to the committee name or currently valid OMB control number.
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Document Created: 2018-10-11 15:36:52
Document Modified: 2018-10-11 15:36:52
| 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 Dermatologic and Ophthalmic Drugs Advisory Committee will expire on October 7, 2018, unless the Commissioner formally determines that renewal is in the public interest. | |
| Contact | LaToya Bonner, 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: [email protected] | |
| FR Citation | 83 FR 51464 |
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