83 FR 31398 - Statement of Organizations, Functions, and Delegations of Authority
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 129 (July 5, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 129 (July 5, 2018)
| Page Range | 31398-31399 | |
| FR Document | 2018-14375 |
[Federal Register Volume 83, Number 129 (Thursday, July 5, 2018)] [Notices] [Pages 31398-31399] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-14375] ======================================================================= ----------------------------------------------------------------------- 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: http://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
![31398 Federal Register / Vol. 83, No. 129 / Thursday, July 5, 2018 / Notices
52.247–64 a statement on vouchers SUMMARY: Statement of Organizations, stakeholders. This reorganization is
involving such transportation. The Functions, and Delegations of explained in Staff Manual Guides
contracting officer uses the information Authority. 1160.1, 1230A.1, 1231.10, 1231.19,
furnished in the statement to determine The Food and Drug Administration 1231.22, 1231.23, and 1241.1.
whether adequate justification exists for (FDA) is announcing that it has FDA, OFVM and CFSAN have been
the contractor’s use of other than a U.S.- reorganized the Office of Foods and restructured as follows:
flag air carrier. Veterinary Medicine (OFVM), Center for DJJ Organization. OFVM is headed by
Food Safety and Applied Nutrition the Deputy Commissioner for Foods and
B. Annual Reporting Burden
(CFSAN) by establishing the new Office Veterinary Medicine and includes the
Respondents: 150. of Executive Programs (OEP); realigning following organizational units:
Responses Per Respondent: 2. OFVM’s Office of Coordinated Outbreak Office of Foods and Veterinary
Annual Responses: 300. Response and Evaluation (CORE) Medicine (DJJ)
Hours per Response: .25. Network along with its Prevention Staff Communications and Public
Total Burden Hours: 75. and Response Staff under CFSAN; and Engagement Staff (DJJ1)
C. Public Comments retitling the Office of Regulations, Office of Resource Planning and
Policy, and Social Science (ORPSS) to Strategic Management (DJJA)
A notice was published in the Federal the Office of Regulations and Policy Center for Food Safety and Applied
Register at 83 FR 12949 on March 26, (ORP). With the retitling to ORP, the Nutrition (DJJH) Center for Veterinary
2018. No comments were received. Regulations and Special Government Medicine (DJJV)
Public comments are particularly Employee Management Staff was
invited on: Whether this collection of DJJH Organization. CFSAN is headed
retitled to the Regulations Development by the Center Director and includes the
information is necessary for the proper Staff, and the Government Information
performance of functions of the FAR, following organizational units:
Staff was established. This
and whether it will have practical reorganization resulted in the Center for Food Safety and Applied
utility; whether our estimate of the abolishment of OFVM’s Executive Nutrition (DJJH)
public burden of this collection of Secretariat Staff, CFSAN’s Office of the Office of the Center Director (DJJHA)
information is accurate, and based on Center Director’s (OCD) Executive Office of Management (DJJHB)
valid assumptions and methodology; Operations Staff, and the Division of Office of Analytics and Outreach
ways to enhance the quality, utility, and Social Sciences under the former (DJJHC)
clarity of the information to be ORPSS. This new organizational Office of Food Safety (DJJHD)
collected; and ways in which we can structure was approved by the Acting Office of Cosmetics and Colors (DJJHE)
minimize the burden of the collection of Secretary of Health and Human Services Office of Regulatory Science (DJJHF)
information on those who are to and applicable on December 7, 2017. Office of Food Additive Safety (DJJHG)
respond, through the use of appropriate Office of Compliance (DJJHH)
FOR FUTHER INFORMATION CONTACT:
technological collection techniques or Office of Applied Research and Safety
Jeffrey Domanski, Associate Director for Assessment (DJJHI)
other forms of information technology.
Management, Center for Food Safety Office of Regulations and Policy (DJJHJ)
Obtaining Copies of Proposals:
and Applied Nutrition, Office of Foods Office of Nutrition and Food Labeling
Requesters may obtain a copy of the
and Veterinary Medicine, Food and (DJJHK)
information collection documents from
Drug Administration, 5001 Campus Office of Dietary Supplement Programs
the General Services Administration,
Drive, College Park, MD 20740, 240– (DJJHL)
Regulatory Secretariat Division (MVCB),
402–2471. Office of Executive Programs (DJJHM)
1800 F Street, NW, Washington, DC,
I. Part D, Chapter D–B, (Food and Office of Coordinated Outbreak
20405, telephone 202–501–4755. Please
Drug Administration), the Statement of Response and Evaluation Network
cite OMB Control No. 9000–0054, U.S.-
Organizations, Functions, and (DJJHN)
Flag Air Carriers Statement, in all
Delegations of Authority for the
correspondence. DJJHJ Organization. ORP is headed by
Department of Health Human Services
Dated: June 29, 2018. (35 FR 3685, February 25, 1970; 60 FR the Office Director and includes the
William F. Clark, 56605, November 9, 1995; 64 FR 36361, following organizational units:
Director, Office of Governmentwide July 6, 1999; 72 FR 50112, August 30, Office of Regulations and Policy (DJJHJ)
Acquisition Policy, Office of Acquisition 2007; 74 FR 41713, August 18, 2009; Regulations Development Staff (DJJHJ1)
Policy, Office of Governmentwide Policy. and 76 FR 45270, July 28, 2011) is Government Information Staff (DJJHJ2)
[FR Doc. 2018–14409 Filed 7–3–18; 8:45 am] amended to reflect the realigning of DJJHM Organization. OEP is headed
BILLING CODE 6820–EP–P functions and personnel from OFVM’s by the Office Director and includes the
abolished Executive Secretariat Staff following organizational unit:
and CFSAN OCD’s Executive Office of Executive Programs (DJJHM)
DEPARTMENT OF HEALTH AND Operations Staff to the newly
established OEP, which will strengthen DJJHN Organization. CORE is headed
HUMAN SERVICES
OFVM’s capacity to coordinate across by the Office Director and includes the
Food and Drug Administration the various components of the Foods following organizational units:
and Veterinary Medicine Program and Office of Coordinated Outbreak
Statement of Organizations, Functions, better meet the day-to-day needs of its Response and Evaluation Network
amozie on DSK3GDR082PROD with NOTICES1
and Delegations of Authority senior leadership. CORE is now (DJJHN)
reflected under CFSAN to facilitate Prevention Staff (DJJHN1)
AGENCY: Office of Foods and Veterinary
greater collaboration, coordination, and Response Staff (DJJHN2)
Medicine, Center for Food Safety and
Applied Nutrition, Food and Drug leveraging of resources. ORP formalizes I. Delegations of Authority. Pending
Administration, HHS. previous informal programs clarifying further delegation, directives, or orders
staff allocation, management, and by the Commissioner of Food and
ACTION: Notice.
leadership for internal and external Drugs, all delegations and redelegations
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![Federal Register / Vol. 83, No. 129 / Thursday, July 5, 2018 / Notices 31399
of authority made to officials and DATES: The announcement of the • Confidential Submissions—To
employees of affected organizational guidance is published in the Federal submit a comment with confidential
components will continue in them or Register on July 5, 2018. information that you do not wish to be
their successors pending further ADDRESSES: You may submit either made publicly available, submit your
redelegations, provided they are electronic or written comments on comments only as a written/paper
consistent with this reorganization. Agency guidances at any time as submission. You should submit two
II. Electronic Access. Persons follows: copies total. One copy will include the
interested in seeing the completed Staff information you claim to be confidential
Electronic Submissions with a heading or cover note that states
Manual Guide can find it on FDA’s
Webs site at: http://www.fda.gov/ Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS
AboutFDA/ReportsManualsForms/ following way: CONFIDENTIAL INFORMATION.’’ The
StaffManualGuides/default.htm. • Federal eRulemaking Portal: Agency will review this copy, including
https://www.regulations.gov. Follow the the claimed confidential information, in
(Authority: 44 U.S.C. § 3101.)
instructions for submitting comments. its consideration of comments. The
Dated: June 28, 2018. Comments submitted electronically, second copy, which will have the
Alex M. Azar II, including attachments, to https:// claimed confidential information
Secretary. www.regulations.gov will be posted to redacted/blacked out, will be available
[FR Doc. 2018–14375 Filed 7–3–18; 8:45 am] the docket unchanged. Because your for public viewing and posted on
BILLING CODE 4164–01–P comment will be made public, you are https://www.regulations.gov. Submit
solely responsible for ensuring that your both copies to the Dockets Management
comment does not include any Staff. If you do not wish your name and
DEPARTMENT OF HEALTH AND confidential information that you or a contact information to be made publicly
HUMAN SERVICES third party may not wish to be posted, available, you can provide this
such as medical information, your or information on the cover sheet and not
Food and Drug Administration anyone else’s Social Security number, or in the body of your comments and you
confidential business information, such must identify this information as
[Docket No. FDA–2017–D–5670] as a manufacturing process. Please note ‘‘confidential.’’ Any information marked
that if you include your name, contact as ‘‘confidential’’ will not be disclosed
Abbreviated New Drug Application information, or other information that except in accordance with 21 CFR 10.20
Submissions—Amendments to identifies you in the body of your and other applicable disclosure law. For
Abbreviated New Drug Applications comments, that information will be more information about FDA’s posting
Under the Generic Drug User Fee Act; posted on https://www.regulations.gov. of comments to public dockets, see 80
Guidance for Industry; Availability • If you want to submit a comment FR 56469, September 18, 2015, or access
with confidential information that you the information at: https://www.gpo.gov/
AGENCY: Food and Drug Administration, do not wish to be made available to the fdsys/pkg/FR-2015-09-18/pdf/2015-
HHS. public, submit the comment as a 23389.pdf.
ACTION: Notice of availability. written/paper submission and in the Docket: For access to the docket to
manner detailed (see ‘‘Written/Paper read background documents or the
SUMMARY: The Food and Drug Submissions’’ and ‘‘Instructions’’). electronic and written/paper comments
Administration (FDA or Agency) is received, go to https://
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announcing the availability of a final
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industry ‘‘ANDA Submissions— Drug Administration, 5630 Fishers Rockville, MD 20852.
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guidance is intended to explain to submitted to the Dockets Management 10.115(g)(5)).
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classifications and categories and Under GDUFA.’’ Received comments INFORMATION section for electronic
amozie on DSK3GDR082PROD with NOTICES1
explains how amendment submissions will be placed in the docket and, except access to the guidance document.
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dates. The guidance also describes how Submissions,’’ publicly viewable at Elizabeth Giaquinto Friedman, Center
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Document Created: 2018-07-03 23:40:13
Document Modified: 2018-07-03 23:40:13
| 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. | |
| FR Citation | 83 FR 31398 |
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