66856 Federal Register / Vol. 88, No. 187 / Thursday, September 28, 2023 / Notices 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued 

21 CFR section Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average burden 

per response 

(in hours) 

Total hours 

CPA Requests for NDA/Biologics License Application Products .................. 1 1 1 5 .................................... 5 

Total ........................................................................................................ .................... ........................ ........................ ....................................... 3,476,650 

1Total burden hours have been rounded. 

2We have included burden attendant to subpart H applications activity in our estimate of burden associated with § 314.50. 

Our estimated burden for the 

information collection reflects an 

overall decrease of 642,293.5 hours. The 

reporting period for this information 

collection renewal includes the 3 years 

of the COVID–19 pandemic. We 

attribute this adjustment to a decrease in 

the number of submissions received 

during the public health emergency. We 

anticipate that the numbers of 

submissions to FDA will return to prepandemic levels as economic activity 

recovers. We also attribute a portion of 

the burden adjustment to improved 

operational efficiencies with regard to 

Agency data systems and digital 

submission processes. 

Dated: September 23, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–21256 Filed 9–27–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–3847] 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request; Adverse 

Experience Reporting for Licensed 

Biological Products; and General 

Records 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing an opportunity for public 

comment on the proposed collection of 

certain information by the Agency. 

Under the Paperwork Reduction Act of 

1995 (PRA), Federal Agencies are 

required to publish notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, and 

to allow 60 days for public comment in 

response to the notice. This notice 

solicits comments on the proposed 

extension of the collection of 

information applicable to required 

adverse experience reporting for 

licensed biological products, and 

general records associated with the 

manufacture and distribution of 

biological products. 

DATES: Submit either electronic or 

written comments on the collection of 

information by November 27, 2023. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. Electronic comments must 

be submitted on or before November 27, 

2023. The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of November 27, 2023 

Comments received by mail/hand 

delivery/courier (for written/paper 

submissions) will be considered timely 

if they are postmarked or the delivery 

service acceptance receipt is on or 

before that date. 

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– 

2023–N–3847 for ‘‘Adverse Experience 

Reporting for Licensed Biological 

Products; and General Records.’’ 

Received comments, those filed in a 

timely manner (see ADDRESSES), 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 


ddrumheller on DSK120RN23PROD with NOTICES1

I I I I 
Federal Register / Vol. 88, No. 187 / Thursday, September 28, 2023 / Notices 66857 

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. 

FOR FURTHER INFORMATION CONTACT: 

Domini Bean, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A63, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–5733, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3521), 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, 

including each proposed extension of an 

existing 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. 

Adverse Experience Reporting For 

Licensed Biological Products; and 

General Records—21 CFR Part 600 

OMB Control Number 0910–0308— 

Extension 

This information collection helps 

support implementation of statutory and 

regulatory authorities that govern 

adverse experience reporting. Under the 

Public Health Service Act (PHS Act) (42 

U.S.C. 262), FDA may only approve a 

biologics license application for a 

biological product that is safe, pure, and 

potent. When a biological product is 

approved and enters the market, the 

product is introduced to a larger patient 

population in settings different from 

clinical trials. New information 

generated during the postmarketing 

period offers further insight into the 

benefits and risks of the product, and 

evaluation of this information is 

important to ensure its safe use. 

Regulations implementing adverse 

experience reporting (AER) 

requirements applicable to biological 

products are codified in part 600 (21 

CFR part 600). Regulations applicable to 

combination products subject to 

regulations in part 600 are found in part 

4 (21 CFR part 4)—Regulation of 

Combination Products. The collections 

of information are intended to enable 

FDA to take actions necessary for the 

protection of the public health in 

response to reports of adverse 

experiences related to biologics licensed 

under any provision of section 351 of 

the PHS Act. 

To assist respondents with the 

reporting provisions of the information 

collection, FDA has created both paperbased and electronic forms. Information 

may be submitted electronically through 

MEDWATCH or the Vaccine Adverse 

Experience Reporting System (VAERS). 

AER reports are filed using the 

MEDWATCH Form FDA–3500A 

(approved under OMB control numbers 

0910–0291 and 0910–0645) or the 

VAERS–1. Both versions of the forms 

and instructions are available from the 

internet at https://vaers.hhs.gov/. The 

forms may also be downloaded, 

completed, and submitted to the Agency 

by mail or facsimile. 

For operational efficiency, on March 

20, 2023, we requested, and OMB has 

approved, the addition of burden 

attributable to provisions set forth in 

part 4, subpart B, previously included in 

OMB control number 0910–0834. When 

information regarding an event that 

involves a death or serious injury, or an 

adverse event, associated with the use of 

the combination product is received by 

the product sponsor, the information 

must be provided to the other 

constituent part applicant(s) no later 

than 5 calendar days after receipt under 

§ 4.103. Relatedly, § 4.104 explains how 

and where to submit reports. 

We estimate the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN—BIOLOGICAL PRODUCTS 1

21 CFR section; activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

(in hours) 

Total hours 

600.80(c)(1), 600.80(d), and 600.80(e); postmarketing 15-day Alert Reports 109 3,806.95 414,958 1 414,958 

600.82; notification of discontinuance or interruption in manufacturing ........... 23 1.435 33 2 66 

600.80(c)(2); Periodic Adverse Experience Reports ........................................ 109 3,697 402,973 28 11,283,244 

600.81; distribution reports ............................................................................... 172 5.727 985 1 985 

600.80(h)(2), 600.81(b)(2), and 600.90; waiver requests ................................. 35 1.886 66 1 66 

Total ........................................................................................................... .......................... .......................... ........................ ........................ 11,699,319 

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


ddrumheller on DSK120RN23PROD with NOTICES1
66858 Federal Register / Vol. 88, No. 187 / Thursday, September 28, 2023 / Notices 

TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN—BIOLOGICAL PRODUCTS 1

21 CFR section; activity Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records 

Average 

burden per 

recordkeeper 

(in hours) 

Total hours 

600.12; 2 Maintenance of Records .................................................................... 131 40.145 5,259 32 168,288 

600.12(b)(2); Recall Records ............................................................................ 216 3.4028 735 24 17,640 

600.80(c)(1) and 600.80(k); AER Records ....................................................... 109 7,503.95 817,931 1 817,931 

Total ........................................................................................................... .......................... .......................... ........................ ........................ 1,003,859 

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

2The recordkeeping requirements in § 610.18(b) are included in the estimate for § 600.12. 

TABLE 3—ESTIMATED ANNUAL REPORTING BURDEN—COMBINATION PRODUCTS 1

21 CFR section; activity Number of 

respondents 

Number of 

disclosures 

per respondents 

Total annual 

disclosures 

Average 

burden per 

disclosure 

(in hours) 

Total 

hours 

4.102, 4.103, 4.104, 4.105; Postmarketing Safety Reporting for Combination 

Products, including associated reports and sharing information with other 

constituent part applicants.

11 18 198 0.35 (21 minutes) ... 69 

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

The burden for this information 

collection has changed since the last 

OMB approval. The reporting and 

recordkeeping burden has increased 

mostly due to an increase in the number 

of AER reports submitted to FDA and 

the associated recordkeeping with these 

reports. We have also added burden we 

believe attributable to post marketing 

safety reporting and attendant 

recordkeeping and disclosures, as 

required under part 4, subpart B. 

Dated: September 23, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–21252 Filed 9–27–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of General Medical 

Sciences; Notice of Closed Meetings 

Pursuant to section 1009 of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meetings. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute of 

General Medical Sciences Special Emphasis 

Panel; Renewal of Centers of Biomedical 

Research Excellence (COBRE) (Phase 2). 

Date: November 7–8, 2023. 

Time: 9:30 a.m. to 1:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

National Institute of General Medical 

Sciences, Natcher Building, 45 Center Drive, 

Bethesda, Maryland 20892 (Virtual Meeting). 

Contact Person: Nina Sidorova, Ph.D., 

Scientific Review Officer, Scientific Review 

Branch, National Institute of General Medical 

Sciences, National Institutes of Health, 45 

Center Drive, MSC 6200, Room 3AN18–01, 

Bethesda, Maryland 20892, 301–594–3663, 

sidorova@nigms.nih.gov. 

Name of Committee: National Institute of 

General Medical Sciences Special Emphasis 

Panel; Review of MOSAIC K99/R00 

applications. 

Date: November 9, 2023. 

Time: 10:00 a.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

National Institute of General Medical 

Sciences, Natcher Building, 45 Center Drive, 

Bethesda, Maryland 20892 (Virtual Meeting). 

Contact Person: Rebecca H. Johnson, Ph.D., 

Scientific Review Officer, Office of Scientific 

Review, National Institute of General Medical 

Sciences, National Institutes of Health, 45 

Center Drive, MSC 6200, Room 3AN12B, 

Bethesda, Maryland 20892, 301–594–2771, 

johnsonrh@nigms.nih.gov. 

Name of Committee: National Institute of 

General Medical Sciences Special Emphasis 

Panel; Review of Support for Research 

Excellence (SuRE) Program (R16). 

Date: November 17, 2023. 

Time: 10:00 a.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

National Institute of General Medical 

Sciences, Natcher Building, 45 Center Drive, 

Bethesda, Maryland 20892 (Virtual Meeting). 

Contact Person: Rebecca H. Johnson, Ph.D., 

Scientific Review Officer, Office of Scientific 

Review, National Institute of General Medical 

Sciences, National Institutes of Health, 45 

Center Drive, MSC 6200, Room 3AN12B, 

Bethesda, Maryland 20892, 301–594–2771, 

johnsonrh@nigms.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program No. 93.859, Biomedical Research 

and Research Training, National Institutes of 

Health, HHS) 

Dated: September 22, 2023. 

Miguelina Perez, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2023–21154 Filed 9–27–23; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Heart, Lung, and Blood 

Institute; Notice of Closed Meeting 

Pursuant to section 1009 of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Heart, Lung, and 

Blood Initial Review Group; NHLBI 


ddrumheller on DSK120RN23PROD with NOTICES1