31398 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 

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 


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Federal Register / Vol. 83, No. 129 / Thursday, July 5, 2018 / Notices 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. § 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. 

SUMMARY: 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. 

DATES: 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: 

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. 

• 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/2015- 

23389.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– 


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