Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals, 51464-51465 [2018-22101]
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51464
Federal Register / Vol. 83, No. 197 / Thursday, October 11, 2018 / Notices
Total Annual Responses: 166,140.
Total Burden Hours: 782,520.
Affected Public: Businesses or other
for-profit and not-for-profit institutions.
Frequency: Variable, depending on
the collection.
Obtaining Copies: Requesters may
obtain a copy of the information
collection documents from the General
Services Administration, Regulatory
Secretariat Division (MVCB), 1800 F
Street NW, Washington, DC 20405,
telephone 202–501–4755. Please cite
OMB Control No. 9000–0107, Federal
Acquisition Regulation Part 23
Requirements, in all correspondence.
Dated: October 3, 2018.
Janet Fry,
Director, Federal Acquisition Policy Division,
Office of Governmentwide Acquisition Policy,
Office of Acquisition Policy, Office of
Governmentwide Policy.
[FR Doc. 2018–22030 Filed 10–10–18; 8:45 am]
BILLING CODE 6820–EP–P
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.
Notice; renewal of advisory
committee.
ACTION:
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,
khammond on DSK30JT082PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
20:54 Oct 10, 2018
Jkt 247001
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/
DermatologicandOphthalmic
DrugsAdvisoryCommittee/
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
PO 00000
Frm 00030
Fmt 4703
Sfmt 4703
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2018–N–0341; FDA–
2012–N–0115; FDA–2018–N–1011; FDA–
2010–N–0110; FDA–2012–N–0547; FDA–
2014–N–2347; FDA–2016–D–2285; FDA–
2016–D–1307; FDA–2016–D–4318; FDA–
2016–N–0407; and FDA–2018–N–0270]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approvals
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is publishing a
list of information collections that have
been approved by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT: Ila
S. Mizrachi, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–7726, PRAStaff@
fda.hhs.gov.
SUMMARY:
The
following is a list of FDA information
collections recently approved by OMB
under section 3507 of the Paperwork
Reduction Act of 1995 (44 U.S.C. 3507).
The OMB control number and
expiration date of OMB approval for
each information collection are shown
in table 1. Copies of the supporting
statements for the information
collections are available on the internet
at https://www.reginfo.gov/public/do/
PRAMain. An Agency may not conduct
or sponsor, and a person is not required
to respond to, a collection of
information unless it displays a
currently valid OMB control number.
SUPPLEMENTARY INFORMATION:
E:\FR\FM\11OCN1.SGM
11OCN1
51465
Federal Register / Vol. 83, No. 197 / Thursday, October 11, 2018 / Notices
TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB
OMB control
number
Title of collection
New Animal Drugs for Investigational Use ..............................................................................................................
Guidance for Industry and FDA Staff, Class II Special Controls: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle .........................................................................................
Petition to Request an Exemption from 100 Percent Identity Testing of Dietary Ingredients: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements ...
Prescription Drug Advertisements ...........................................................................................................................
Survey of the Occurrence of Foodborne Illness Risk Factors in Selected Retail and Foodservice Facility Types
Permanent Discontinuation or Interruption in Manufacturing of Certain Drug and Biological Products .................
Food and Cosmetic Export Certificate Applications Process ..................................................................................
Guidance for Industry: Medical Product Communications That are Consistent With the Food and Drug Administration Required Labeling—Questions and Answers ........................................................................................
Guidance for Industry: Drug and Device Manufacturer Communications with Payors, Formulary Committees,
and Similar Entities Questions and Answers .......................................................................................................
Guidance for Industry: Compounding and Repackaging of Radiopharmaceuticals by State-Licensed Nuclear
Pharmacies, Federal Facilities, and Certain Other Entities .................................................................................
Drug Supply Chain Security Act Pilot Program .......................................................................................................
Survey on the Occurrence of Foodborne Illness Risk Factors in Selected Institutional and Retail Food Stores
and Facility Types (2015–2025) ..........................................................................................................................
Dated: October 4, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–22101 Filed 10–10–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–3323]
Advisory Committee; Antimicrobial
Drugs Advisory Committee, Renewal
AGENCY:
Food and Drug Administration,
HHS.
Notice; renewal of advisory
committee.
ACTION:
The Food and Drug
Administration (FDA) is announcing the
renewal of the Antimicrobial 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 Antimicrobial
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 Antimicrobial
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:
Lauren Tesh, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 31, Rm. 2417, Silver Spring,
khammond on DSK30JT082PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
20:54 Oct 10, 2018
Jkt 247001
MD 20993–0002, 301–796–9001, email:
AMDAC@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
Antimicrobial Drugs Advisory
Committee. The committee is a
discretionary Federal advisory
committee established to provide advice
to the Commissioner.
The Antimicrobial 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
available data concerning the safety and
effectiveness of marketed and
investigational human drug products for
use in the treatment of infectious
diseases and disorders and makes
appropriate recommendations to the
Commissioner of Food and Drugs.
The Committee shall consist of a core
of 13 voting members including the
Chair. Members and the Chair are
selected by the Commissioner or
designee from among authorities
knowledgeable in the fields of infectious
disease, internal medicine,
microbiology, pediatrics, 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
PO 00000
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Fmt 4703
Sfmt 4703
Date
approval
expires
0910–0117
8/31/2021
0910–0594
8/31/2021
0910–0608
0910–0686
0910–0744
0910–0759
0910–0793
8/31/2021
8/31/2021
8/31/2021
8/31/2021
8/31/2021
0910–0856
8/31/2021
0910–0857
8/31/2021
0910–0858
0910–0859
8/31/2021
8/31/2021
0910–0799
9/30/2021
member, selected by the Commissioner
or designee, who is identified with
consumer interests and is recommended
by either a consortium of consumeroriented 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/
Anti-InfectiveDrugsAdvisoryCommittee/
ucm094132.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. 2018–22098 Filed 10–10–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Charter Renewal of the Secretary’s
Advisory Committee on Human
Research Protections
Office of the Assistant
Secretary for Health, Office of the
AGENCY:
E:\FR\FM\11OCN1.SGM
11OCN1
]]>Agencies
[Federal Register Volume 83, Number 197 (Thursday, October 11, 2018)]
[Notices]
[Pages 51464-51465]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-22101]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2018-N-0341; FDA-2012-N-0115; FDA-2018-N-1011; FDA-
2010-N-0110; FDA-2012-N-0547; FDA-2014-N-2347; FDA-2016-D-2285; FDA-
2016-D-1307; FDA-2016-D-4318; FDA-2016-N-0407; and FDA-2018-N-0270]
Agency Information Collection Activities; Announcement of Office
of Management and Budget Approvals
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is publishing a list of
information collections that have been approved by the Office of
Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-7726,
[email protected].
SUPPLEMENTARY INFORMATION: The following is a list of FDA information
collections recently approved by OMB under section 3507 of the
Paperwork Reduction Act of 1995 (44 U.S.C. 3507). The OMB control
number and expiration date of OMB approval for each information
collection are shown in table 1. Copies of the supporting statements
for the information collections are available on the internet at
https://www.reginfo.gov/public/do/PRAMain. An Agency may not conduct or
sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB control number.
[[Page 51465]]
Table 1--List of Information Collections Approved by OMB
------------------------------------------------------------------------
OMB control Date approval
Title of collection number expires
------------------------------------------------------------------------
New Animal Drugs for Investigational Use 0910-0117 8/31/2021
Guidance for Industry and FDA Staff, 0910-0594 8/31/2021
Class II Special Controls: Automated
Blood Cell Separator Device Operating
by Centrifugal or Filtration Separation
Principle..............................
Petition to Request an Exemption from 0910-0608 8/31/2021
100 Percent Identity Testing of Dietary
Ingredients: Current Good Manufacturing
Practice in Manufacturing, Packaging,
Labeling, or Holding Operations for
Dietary Supplements....................
Prescription Drug Advertisements........ 0910-0686 8/31/2021
Survey of the Occurrence of Foodborne 0910-0744 8/31/2021
Illness Risk Factors in Selected Retail
and Foodservice Facility Types.........
Permanent Discontinuation or 0910-0759 8/31/2021
Interruption in Manufacturing of
Certain Drug and Biological Products...
Food and Cosmetic Export Certificate 0910-0793 8/31/2021
Applications Process...................
Guidance for Industry: Medical Product 0910-0856 8/31/2021
Communications That are Consistent With
the Food and Drug Administration
Required Labeling--Questions and
Answers................................
Guidance for Industry: Drug and Device 0910-0857 8/31/2021
Manufacturer Communications with
Payors, Formulary Committees, and
Similar Entities Questions and Answers.
Guidance for Industry: Compounding and 0910-0858 8/31/2021
Repackaging of Radiopharmaceuticals by
State-Licensed Nuclear Pharmacies,
Federal Facilities, and Certain Other
Entities...............................
Drug Supply Chain Security Act Pilot 0910-0859 8/31/2021
Program................................
Survey on the Occurrence of Foodborne 0910-0799 9/30/2021
Illness Risk Factors in Selected
Institutional and Retail Food Stores
and Facility Types (2015-2025).........
------------------------------------------------------------------------
Dated: October 4, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-22101 Filed 10-10-18; 8:45 am]
BILLING CODE 4164-01-P
