Statement of Organizations, Functions, and Delegations of Authority, 31398-31399 [2018-14375]
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Federal Register / Vol. 83, No. 129 / Thursday, July 5, 2018 / Notices
52.247–64 a statement on vouchers
involving such transportation. The
contracting officer uses the information
furnished in the statement to determine
whether adequate justification exists for
the contractor’s use of other than a U.S.flag air carrier.
B. Annual Reporting Burden
Respondents: 150.
Responses Per Respondent: 2.
Annual Responses: 300.
Hours per Response: .25.
Total Burden Hours: 75.
C. Public Comments
A notice was published in the Federal
Register at 83 FR 12949 on March 26,
2018. No comments were received.
Public comments are particularly
invited on: Whether this collection of
information is necessary for the proper
performance of functions of the FAR,
and whether it will have practical
utility; whether our estimate of the
public burden of this collection of
information is accurate, and based on
valid assumptions and methodology;
ways to enhance the quality, utility, and
clarity of the information to be
collected; and ways in which we can
minimize the burden of the collection of
information on those who are to
respond, through the use of appropriate
technological collection techniques or
other forms of information technology.
Obtaining Copies of Proposals:
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. 9000–0054, U.S.Flag Air Carriers Statement, in all
correspondence.
Dated: June 29, 2018.
William F. Clark,
Director, Office of Governmentwide
Acquisition Policy, Office of Acquisition
Policy, Office of Governmentwide Policy.
[FR Doc. 2018–14409 Filed 7–3–18; 8:45 am]
BILLING CODE 6820–EP–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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Food and Drug Administration
Statement of Organizations, Functions,
and Delegations of Authority
Office of Foods and Veterinary
Medicine, Center for Food Safety and
Applied Nutrition, Food and Drug
Administration, HHS.
ACTION: Notice.
AGENCY:
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16:43 Jul 03, 2018
Jkt 244001
Statement of Organizations,
Functions, and Delegations of
Authority.
The Food and Drug Administration
(FDA) is announcing that it has
reorganized the Office of Foods and
Veterinary Medicine (OFVM), Center for
Food Safety and Applied Nutrition
(CFSAN) by establishing the new Office
of Executive Programs (OEP); realigning
OFVM’s Office of Coordinated Outbreak
Response and Evaluation (CORE)
Network along with its Prevention Staff
and Response Staff under CFSAN; and
retitling the Office of Regulations,
Policy, and Social Science (ORPSS) to
the Office of Regulations and Policy
(ORP). With the retitling to ORP, the
Regulations and Special Government
Employee Management Staff was
retitled to the Regulations Development
Staff, and the Government Information
Staff was established. This
reorganization resulted in the
abolishment of OFVM’s Executive
Secretariat Staff, CFSAN’s Office of the
Center Director’s (OCD) Executive
Operations Staff, and the Division of
Social Sciences under the former
ORPSS. This new organizational
structure was approved by the Acting
Secretary of Health and Human Services
and applicable on December 7, 2017.
FOR FUTHER INFORMATION CONTACT:
Jeffrey Domanski, Associate Director for
Management, Center for Food Safety
and Applied Nutrition, Office of Foods
and Veterinary Medicine, Food and
Drug Administration, 5001 Campus
Drive, College Park, MD 20740, 240–
402–2471.
I. Part D, Chapter D–B, (Food and
Drug Administration), the Statement of
Organizations, Functions, and
Delegations of Authority for the
Department of Health Human Services
(35 FR 3685, February 25, 1970; 60 FR
56605, November 9, 1995; 64 FR 36361,
July 6, 1999; 72 FR 50112, August 30,
2007; 74 FR 41713, August 18, 2009;
and 76 FR 45270, July 28, 2011) is
amended to reflect the realigning of
functions and personnel from OFVM’s
abolished Executive Secretariat Staff
and CFSAN OCD’s Executive
Operations Staff to the newly
established OEP, which will strengthen
OFVM’s capacity to coordinate across
the various components of the Foods
and Veterinary Medicine Program and
better meet the day-to-day needs of its
senior leadership. CORE is now
reflected under CFSAN to facilitate
greater collaboration, coordination, and
leveraging of resources. ORP formalizes
previous informal programs clarifying
staff allocation, management, and
leadership for internal and external
SUMMARY:
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stakeholders. This reorganization is
explained in Staff Manual Guides
1160.1, 1230A.1, 1231.10, 1231.19,
1231.22, 1231.23, and 1241.1.
FDA, OFVM and CFSAN have been
restructured as follows:
DJJ Organization. OFVM is headed by
the Deputy Commissioner for Foods and
Veterinary Medicine and includes the
following organizational units:
Office of Foods and Veterinary
Medicine (DJJ)
Communications and Public
Engagement Staff (DJJ1)
Office of Resource Planning and
Strategic Management (DJJA)
Center for Food Safety and Applied
Nutrition (DJJH) Center for Veterinary
Medicine (DJJV)
DJJH Organization. CFSAN is headed
by the Center Director and includes the
following organizational units:
Center for Food Safety and Applied
Nutrition (DJJH)
Office of the Center Director (DJJHA)
Office of Management (DJJHB)
Office of Analytics and Outreach
(DJJHC)
Office of Food Safety (DJJHD)
Office of Cosmetics and Colors (DJJHE)
Office of Regulatory Science (DJJHF)
Office of Food Additive Safety (DJJHG)
Office of Compliance (DJJHH)
Office of Applied Research and Safety
Assessment (DJJHI)
Office of Regulations and Policy (DJJHJ)
Office of Nutrition and Food Labeling
(DJJHK)
Office of Dietary Supplement Programs
(DJJHL)
Office of Executive Programs (DJJHM)
Office of Coordinated Outbreak
Response and Evaluation Network
(DJJHN)
DJJHJ Organization. ORP is headed by
the Office Director and includes the
following organizational units:
Office of Regulations and Policy (DJJHJ)
Regulations Development Staff (DJJHJ1)
Government Information Staff (DJJHJ2)
DJJHM Organization. OEP is headed
by the Office Director and includes the
following organizational unit:
Office of Executive Programs (DJJHM)
DJJHN Organization. CORE is headed
by the Office Director and includes the
following organizational units:
Office of Coordinated Outbreak
Response and Evaluation Network
(DJJHN)
Prevention Staff (DJJHN1)
Response Staff (DJJHN2)
I. Delegations of Authority. Pending
further delegation, directives, or orders
by the Commissioner of Food and
Drugs, all delegations and redelegations
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Federal Register / Vol. 83, No. 129 / Thursday, July 5, 2018 / Notices
of authority made to officials and
employees of affected organizational
components will continue in them or
their successors pending further
redelegations, provided they are
consistent with this reorganization.
II. Electronic Access. Persons
interested in seeing the completed Staff
Manual Guide can find it on FDA’s
Webs site at: https://www.fda.gov/
AboutFDA/ReportsManualsForms/
StaffManualGuides/default.htm.
(Authority: 44 U.S.C. § 3101.)
Dated: June 28, 2018.
Alex M. Azar II,
Secretary.
[FR Doc. 2018–14375 Filed 7–3–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–D–5670]
Abbreviated New Drug Application
Submissions—Amendments to
Abbreviated New Drug Applications
Under the Generic Drug User Fee Act;
Guidance for Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a final
guidance for industry entitled ‘‘ANDA
Submissions—Amendments to
Abbreviated New Drug Applications
Under GDUFA.’’ This guidance finalizes
the October 2017 draft guidance for
industry ‘‘ANDA Submissions—
Amendments to Abbreviated New Drug
Applications Under GDUFA.’’ This
guidance is intended to explain to
applicants how the review goals
established as part of the Generic Drug
User Fee Amendments Reauthorization
of 2017 (GDUFA II) apply to
amendments to either abbreviated new
drug applications (ANDAs) or prior
approval supplements (PASs) submitted
to FDA under the Federal Food, Drug,
and Cosmetic Act (FD&C Act). This
guidance describes amendment
classifications and categories and
explains how amendment submissions
may affect an application’s review goal
dates. The guidance also describes how
FDA will review amendments submitted
to ANDAs and PASs received prior to
October 1, 2017, the effective date to
implement the GDUFA II review goals.
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SUMMARY:
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The announcement of the
guidance is published in the Federal
Register on July 5, 2018.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
DATES:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
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 https://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): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, 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–
2017–D–5670 for ‘‘ANDA
Submissions—Amendments to
Abbreviated New Drug Applications
Under GDUFA.’’ Received comments
will be placed in the docket and, except
for those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday.
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31399
• 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
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. 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: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
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 Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single
copies of this guidance to the Division
of Drug Information, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993–
0002. Send one self-addressed adhesive
label to assist that office in processing
your requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the guidance document.
FOR FURTHER INFORMATION CONTACT:
Elizabeth Giaquinto Friedman, Center
for Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 1670,
Silver Spring, MD 20993–0002, 240–
E:\FR\FM\05JYN1.SGM
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]]>Agencies
[Federal Register Volume 83, Number 129 (Thursday, July 5, 2018)]
[Notices]
[Pages 31398-31399]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-14375]
=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Statement of Organizations, Functions, and Delegations of
Authority
AGENCY: Office of Foods and Veterinary Medicine, Center for Food Safety
and Applied Nutrition, Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: Statement of Organizations, Functions, and Delegations of
Authority.
The Food and Drug Administration (FDA) is announcing that it has
reorganized the Office of Foods and Veterinary Medicine (OFVM), Center
for Food Safety and Applied Nutrition (CFSAN) by establishing the new
Office of Executive Programs (OEP); realigning OFVM's Office of
Coordinated Outbreak Response and Evaluation (CORE) Network along with
its Prevention Staff and Response Staff under CFSAN; and retitling the
Office of Regulations, Policy, and Social Science (ORPSS) to the Office
of Regulations and Policy (ORP). With the retitling to ORP, the
Regulations and Special Government Employee Management Staff was
retitled to the Regulations Development Staff, and the Government
Information Staff was established. This reorganization resulted in the
abolishment of OFVM's Executive Secretariat Staff, CFSAN's Office of
the Center Director's (OCD) Executive Operations Staff, and the
Division of Social Sciences under the former ORPSS. This new
organizational structure was approved by the Acting Secretary of Health
and Human Services and applicable on December 7, 2017.
FOR FUTHER INFORMATION CONTACT: Jeffrey Domanski, Associate Director
for Management, Center for Food Safety and Applied Nutrition, Office of
Foods and Veterinary Medicine, Food and Drug Administration, 5001
Campus Drive, College Park, MD 20740, 240-402-2471.
I. Part D, Chapter D-B, (Food and Drug Administration), the
Statement of Organizations, Functions, and Delegations of Authority for
the Department of Health Human Services (35 FR 3685, February 25, 1970;
60 FR 56605, November 9, 1995; 64 FR 36361, July 6, 1999; 72 FR 50112,
August 30, 2007; 74 FR 41713, August 18, 2009; and 76 FR 45270, July
28, 2011) is amended to reflect the realigning of functions and
personnel from OFVM's abolished Executive Secretariat Staff and CFSAN
OCD's Executive Operations Staff to the newly established OEP, which
will strengthen OFVM's capacity to coordinate across the various
components of the Foods and Veterinary Medicine Program and better meet
the day-to-day needs of its senior leadership. CORE is now reflected
under CFSAN to facilitate greater collaboration, coordination, and
leveraging of resources. ORP formalizes previous informal programs
clarifying staff allocation, management, and leadership for internal
and external stakeholders. This reorganization is explained in Staff
Manual Guides 1160.1, 1230A.1, 1231.10, 1231.19, 1231.22, 1231.23, and
1241.1.
FDA, OFVM and CFSAN have been restructured as follows:
DJJ Organization. OFVM is headed by the Deputy Commissioner for
Foods and Veterinary Medicine and includes the following organizational
units:
Office of Foods and Veterinary Medicine (DJJ)
Communications and Public Engagement Staff (DJJ1)
Office of Resource Planning and Strategic Management (DJJA)
Center for Food Safety and Applied Nutrition (DJJH) Center for
Veterinary Medicine (DJJV)
DJJH Organization. CFSAN is headed by the Center Director and
includes the following organizational units:
Center for Food Safety and Applied Nutrition (DJJH)
Office of the Center Director (DJJHA)
Office of Management (DJJHB)
Office of Analytics and Outreach (DJJHC)
Office of Food Safety (DJJHD)
Office of Cosmetics and Colors (DJJHE)
Office of Regulatory Science (DJJHF)
Office of Food Additive Safety (DJJHG)
Office of Compliance (DJJHH)
Office of Applied Research and Safety Assessment (DJJHI)
Office of Regulations and Policy (DJJHJ)
Office of Nutrition and Food Labeling (DJJHK)
Office of Dietary Supplement Programs (DJJHL)
Office of Executive Programs (DJJHM)
Office of Coordinated Outbreak Response and Evaluation Network (DJJHN)
DJJHJ Organization. ORP is headed by the Office Director and
includes the following organizational units:
Office of Regulations and Policy (DJJHJ)
Regulations Development Staff (DJJHJ1)
Government Information Staff (DJJHJ2)
DJJHM Organization. OEP is headed by the Office Director and
includes the following organizational unit:
Office of Executive Programs (DJJHM)
DJJHN Organization. CORE is headed by the Office Director and
includes the following organizational units:
Office of Coordinated Outbreak Response and Evaluation Network (DJJHN)
Prevention Staff (DJJHN1)
Response Staff (DJJHN2)
I. Delegations of Authority. Pending further delegation,
directives, or orders by the Commissioner of Food and Drugs, all
delegations and redelegations
[[Page 31399]]
of authority made to officials and employees of affected organizational
components will continue in them or their successors pending further
redelegations, provided they are consistent with this reorganization.
II. Electronic Access. Persons interested in seeing the completed
Staff Manual Guide can find it on FDA's Webs site at: https://www.fda.gov/AboutFDA/ReportsManualsForms/StaffManualGuides/default.htm.
(Authority: 44 U.S.C. Sec. 3101.)
Dated: June 28, 2018.
Alex M. Azar II,
Secretary.
[FR Doc. 2018-14375 Filed 7-3-18; 8:45 am]
BILLING CODE 4164-01-P
