Federal Register / Vol. 89, No. 8 / Thursday, January 11, 2024 / Notices 1923 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–D–5868] 

Requests for Reconsideration at the 

Division Level Under the Generic Drug 

User Fee Amendments; Draft Guidance 

for Industry; Availability; Agency 

Information Collection Activities; 

Proposed Collection; Comment 

Request 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) is 

announcing the availability of a draft 

guidance for industry entitled ‘‘Requests 

for Reconsideration at the Division 

Level Under GDUFA.’’ This draft 

guidance provides recommendations on 

the procedures for applicants of 

abbreviated new drug applications 

(ANDAs) that wish to pursue a request 

for reconsideration within the review 

discipline at the division level or 

original signatory authority. This draft 

guidance revises the draft guidance of 

the same title issued in October 2017. 

This revision is being issued to reflect 

the most recent reauthorization of the 

Generic Drug User Fee Amendments 

(GDUFA) and to clarify what matters are 

appropriate for requests for 

reconsideration. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by March 11, 2024 to ensure that the 

Agency considers your comment on this 

draft guidance before it begins work on 

the final version of the guidance. 

Submit electronic or written comments 

on the proposed collection of 

information in the draft guidance by 

March 11, 2024. 

ADDRESSES: You may submit comments 

on any guidance 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–5868 for ‘‘Requests for 

Reconsideration at the Division Level 

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, 240–402–7500. 

• 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.govinfo.gov/content/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, 240–402–7500. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). 

Submit written requests for single 

copies of the draft 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 draft guidance document. 

FOR FURTHER INFORMATION CONTACT: 

With regard to the draft guidance: 

Martha Nguyen, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 75, Rm. 1676, 

Silver Spring, MD 20903, 240–695– 

3412, Martha.Nguyen@fda.hhs.gov; 

With regard to the proposed collection 

of information: Duong T (Diane) Nhu, 

Office of Operations, Food and Drug 

Administration, Three White Flint 

North, 10A–12M, 11601 Landsdown St., 

North Bethesda, MD 20852, 240–402– 

3953, PRAStaff@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Requests for Reconsideration at the 

Division Level Under GDUFA.’’ This 

draft guidance provides 

recommendations on the procedures for 

applicants of ANDAs that wish to 

pursue a request for reconsideration 

within the review discipline at the 

division level or original signatory 

authority. Requests within the scope of 

this guidance document should concern 

certain actions that relate to an ANDA 

and have scientific significance. 


ddrumheller on DSK120RN23PROD with NOTICES1
1924 Federal Register / Vol. 89, No. 8 / Thursday, January 11, 2024 / Notices 

During the assessment of an ANDA, 

FDA considers important issues that are 

central to product evaluation. 

Sometimes, an applicant may disagree 

with FDA, and because these 

disagreements often involve intricate 

matters, it is critical to have procedures 

in place to ensure open and prompt 

consideration of an applicant’s 

concern(s). The procedures and policies 

described in this guidance are intended 

to formalize FDA’s current and 

historical practices and to continue to 

promote rapid and fair resolution of 

eligible requests between an applicant 

and FDA. This draft guidance revises 

the draft guidance of the same title 

issued on October 12, 2017 (82 FR 

47531). This revision is being issued to 

reflect the most recent reauthorization 

of GDUFA in the Continuing 

Appropriations and Ukraine 

Supplemental Appropriations Act, 2023 

(Division F, Title III, Pub. L. 117–180, 

136 Stat. 2155), and to clarify what 

matters are appropriate for requests for 

reconsideration. 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the current thinking of FDA 

on ‘‘Requests for Reconsideration at the 

Division Level Under GDUFA.’’ It does 

not establish any rights for any person 

and is not binding on FDA or the public. 

You can use an alternative approach if 

it satisfies the requirements of the 

applicable statutes and regulations. 

II. Paperwork Reduction Act of 1995 

Under the Paperwork Reduction Act 

of 1995 (PRA) (44 U.S.C. 3501–3520), 

Federal agencies must obtain approval 

from the Office of Management and 

Budget (OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes Agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Applications for FDA Approval To 

Market a New Drug 

OMB Control Number 0910–0001— 

Revision 

The information collection request 

supports the Agency’s draft guidance 

entitled, ‘‘Requests for Reconsideration 

at the Division Level Under GDUFA.’’ 

As discussed in section I of this notice, 

this draft guidance provides information 

to respondents regarding procedures for 

submitting requests for reconsideration, 

including details on the content and 

format of the submission. Respondents 

to the collection of information are 

applicants of ANDAs. Based on 

available data with regard to similar 

information collections, FDA’s Center 

for Drug Evaluation and Research will 

receive approximately 310 requests for 

reconsideration annually from 155 

respondents. Because we estimate it will 

take 5 hours to prepare a request for 

reconsideration, we estimate it will take 

an average of 1,550 total hours annually 

for respondents to prepare and submit 

requests for reconsideration. 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Section of guidance/reporting activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

(in hours) 

Total hours 

Section IV: Procedures for Submitting and Responding to 

a Request for Reconsideration ........................................ 155 2 310 5 1,550 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

This draft guidance refers to 

previously approved FDA collections of 

information found in FDA regulations. 

The collections of information in 21 

CFR part 314 have been approved under 

OMB control number 0910–0001. The 

collections of information pertaining to 

the GDUFA III commitment letter, 

meetings related to generic drug 

development, and the Generic Drug 

User Fee Program have been approved 

under OMB control number 0910–0727. 

III. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at https:// 

www.fda.gov/drugs/guidancecompliance-regulatory-information/ 

guidances-drugs, https://www.fda.gov/ 

regulatory-information/search-fdaguidance-documents, or https://

www.regulations.gov. 

Dated: January 8, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–00403 Filed 1–10–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2020–N–0026] 

Issuance of Priority Review Voucher; 

Rare Pediatric Disease Product 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

issuance of a priority review voucher to 

the sponsor of a rare pediatric disease 

product application. The Federal Food, 

Drug, and Cosmetic Act (FD&C Act) 


ddrumheller on DSK120RN23PROD with NOTICES1