Federal Register / Vol. 89, No. 18 / Friday, January 26, 2024 / Notices 5241 

Evaluation and Research, Food and 

Drug Administration, 10001 New 

Hampshire Ave., Hillandale Building, 

4th Floor, Silver Spring, MD 20993– 

0002 or the Office of Communication, 

Outreach and Development, Center for 

Biologics Evaluation and Research, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 71, Rm. 

3128, 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 document. 

FOR FURTHER INFORMATION CONTACT: Sara 

Camilli, Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 22, Rm. 3486, Silver Spring, 

MD 20993–0002, 301–796–4203, 

Sara.Camilli@fda.hhs.gov; or James 

Myers, Center for Biologics Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 71, Rm. 7301, Silver Spring, 

MD 20993–0002, 240–402–7911. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a final document entitled ‘‘Best 

Practices for FDA Staff in the 

Postmarketing Safety Surveillance of 

Human Drug and Biological Products.’’ 

Title IX, section 915 of the Food and 

Drug Administration Amendments Act 

of 2007 (FDAAA) (Pub. L. 110–85) 

added section 505(r) to the Federal 

Food, Drug, and Cosmetic Act (FD&C 

Act) (21 U.S.C. 355(r)), requiring FDA to 

prepare a summary analysis of the 

adverse drug reaction reports received 

for a drug by 18 months after approval 

or after use of the drug by 10,000 

individuals, whichever is later. The 

analysis includes identification of any 

new risks not previously identified, 

potential new risks, or known risks 

reported in unusual number. 

Section 3075 of the Cures Act (Pub. L. 

114–255) amended section 505(r)(2)(D) 

of the FD&C Act to eliminate the 

requirement for summary analyses for 

drugs as required by FDAAA. In place 

of the summary analyses, section 3075 

amended section 505(r)(2)(D) of the 

FD&C Act to include the requirement 

that FDA make publicly available on its 

internet website best practices for drug 

safety surveillance activities for drugs 

approved under section 505 of the FD&C 

Act or section 351 of the Public Health 

Service Act (PHS Act). 

Section 3075 of the Cures Act also 

amended section 505(k)(5) of the FD&C 

Act to strike ‘‘bi-weekly screening,’’ in 

subparagraph (A), and insert 

‘‘screenings’’; it also added the 

requirement that FDA make publicly 

available on its internet website 

guidelines, developed with input from 

experts qualified by scientific training 

and experience to evaluate the safety 

and effectiveness of drugs, that detail 

best practices for drug safety 

surveillance using the Adverse Event 

Reporting System. 

The final document entitled ‘‘Best 

Practices for FDA Staff in the 

Postmarketing Safety Surveillance of 

Human Drugs and Biological Products’’ 

sets forth risk-based principles for 

FDA’s conduct of ongoing 

postmarketing safety surveillance for 

human drug products and human 

biological products to address the Cures 

Act requirements. Although section 

3075 of the Cures Act only references 

drugs approved under section 505 of the 

FD&C Act or section 351 of the PHS Act, 

the document additionally discusses 

other products, including 

nonprescription drug products, 

compounded drug products, and 

homeopathic products. The document 

also includes a high-level overview of 

other drug safety surveillance data 

sources, tools, methods, and activities 

that extend beyond use of FDA’s 

adverse event reporting systems, as well 

as regulatory and other actions that can 

be taken in response to identified safety 

signals. These additional topics are 

included to provide context and a 

general overview of FDA’s safety 

surveillance process. 

This document finalizes the draft 

document entitled ‘‘Best Practices in 

Drug and Biological Product Postmarket 

Safety Surveillance for FDA Staff,’’ 

issued on November 7, 2019 (84 FR 

60094). FDA considered comments 

received on the draft document as the 

document was finalized. Changes from 

the draft to the final document include: 

(1) document title revised to emphasize 

this document’s focus on postmarketing 

safety surveillance and to clarify that 

this document only refers to human 

drug and biological products that are 

regulated by FDA, as this document 

does not refer to animal drugs regulated 

by FDA; (2) additional content to 

distinguish between the use of the terms 

adverse event and adverse reaction; (3) 

clarification of products that generally 

are subject to more extensive monitoring 

and types of safety information for 

focus; (4) addition of a description of 

the FDA Adverse Event Reporting 

System Public Dashboard; (5) revisions 

to the content on medication errors, for 

clarity; (6) revisions to the section on 

the pregnant population to align with 

the most recently issued documents 

pertaining to clinical trials and 

postapproval pregnancy safety studies; 

(7) inclusion of citations referencing the 

Sentinel System; (8) revisions to the 

description of the process for signal 

evaluation and documentation, 

including addition of a reference to the 

Center for Drug Evaluation and 

Research’s ‘‘Manual of Policies and 

Procedures for Collaborative 

Identification, Evaluation, and 

Resolution of a Newly Identified Safety 

Signal’’; (9) inclusion of an expanded 

discussion of product labeling changes; 

and (10) additional content regarding 

Drug Safety Communications. Editorial 

changes were made to improve clarity. 

II. Electronic Access 

Persons with access to the internet 

may obtain the document at https://

www.fda.gov/about-fda/center-drugevaluation-and-research-cder/cderoffice-surveillance-and-epidemiology or 

https://www.regulations.gov. 

Dated: January 23, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–01584 Filed 1–25–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–2853] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Recordkeeping 

and Reporting Requirements for 

Human Food and Cosmetics 

Manufactured From, Processed With, 

or Otherwise Containing Material From 

Cattle 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Submit written comments 

(including recommendations) on the 

collection of information by February 

26, 2024. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be submitted to https://

www.reginfo.gov/public/do/PRAMain. 

Find this particular information 


lotter on DSK11XQN23PROD with NOTICES1
5242 Federal Register / Vol. 89, No. 18 / Friday, January 26, 2024 / Notices 

collection by selecting ‘‘Currently under 

Review—Open for Public Comments’’ or 

by using the search function. The OMB 

control number for this information 

collection is 0910–0623. Also include 

the FDA docket number found in 

brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Amber Sanford, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–8867, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Recordkeeping and Reporting 

Requirements for Human Food and 

Cosmetics Manufactured From, 

Processed With, or Otherwise 

Containing Material From Cattle—21 

CFR 189.5 and 700.27 

OMB Control No. 0910–0623—Extension 

This information collection supports 

FDA regulations in §§ 189.5 and 700.27 

(21 CFR 189.5 and 700.27) that set forth 

bovine spongiform encephalopathy 

(BSE)-related restrictions applicable to 

FDA-regulated human food and 

cosmetics. The regulations designate 

certain materials from cattle as 

‘‘prohibited cattle materials,’’ including 

specified risk materials (SRMs), the 

small intestine of cattle not otherwise 

excluded from being a prohibited cattle 

material, material from nonambulatory 

disabled cattle, and mechanically 

separated (MS) beef. Sections 189.5(c) 

and 700.27(c) set forth the requirements 

for recordkeeping and records access for 

FDA-regulated human food, including 

dietary supplements, and cosmetics 

manufactured from, processed with, or 

otherwise containing material derived 

from cattle. FDA issued these 

recordkeeping regulations under the 

adulteration provisions in sections 

402(a)(2)(C), (a)(3), (a)(4), (a)(5), 601(c), 

and 701(a) of the Federal Food, Drug, 

and Cosmetic Act (FD&C Act) (21 U.S.C. 

342(a)(2)(C), (a)(3), (a)(4), (a)(5), 361(c), 

and 371(a)). Under section 701(a) of the 

FD&C Act, we are authorized to issue 

regulations for the FD&C Act’s efficient 

enforcement. With regard to records 

concerning imported human food and 

cosmetics, FDA relied on our authority 

under sections 701(b) and 801(a) of the 

FD&C Act (21 U.S.C. 371(b) and 381(a)). 

Section 801(a) of the FD&C Act provides 

requirements with regard to imported 

human food and cosmetics and provides 

for refusal of admission of human food 

and cosmetics that appear to be 

adulterated into the United States. 

Section 701(b) of the FD&C Act 

authorizes the Secretaries of Treasury 

and Health and Human Services to 

jointly prescribe regulations for the 

efficient enforcement of section 801 of 

the FD&C Act. 

These requirements are necessary 

because once materials are separated 

from an animal it may not be possible, 

without records, to know the following: 

(1) whether cattle material may contain 

SRMs (brain, skull, eyes, trigeminal 

ganglia, spinal cord, vertebral column 

(excluding the vertebrae of the tail, the 

transverse processes of the thoracic and 

lumbar vertebrae, and the wings of the 

sacrum), and dorsal root ganglia from 

animals 30 months and older and 

tonsils and distal ileum of the small 

intestine from all animals of all ages); 

(2) whether the source animal for cattle 

material was inspected and passed; (3) 

whether the source animal for cattle 

material was nonambulatory disabled, 

or MS beef; and (4) whether tallow in 

human food or cosmetics contain less 

than 0.15 percent insoluble impurities. 

FDA’s regulations in §§ 189.5(c) and 

700.27(c) require manufacturers and 

processors of human food and cosmetics 

manufactured from, processed with, or 

otherwise containing material from 

cattle establish and maintain records 

sufficient to demonstrate that the 

human food or cosmetics are not 

manufactured from, processed with, or 

otherwise contain prohibited cattle 

materials. These records must be 

retained for 2 years at the manufacturing 

or processing establishment or at a 

reasonably accessible location. 

Maintenance of electronic records is 

acceptable, and electronic records are 

considered to be reasonably accessible if 

they are accessible from an onsite 

location. Records required by these 

sections and existing records relevant to 

compliance with these sections must be 

available to FDA for inspection and 

copying. Existing records may be used 

if they contain all of the required 

information and are retained for the 

required time period. 

Because we do not easily have access 

to records maintained at foreign 

establishments, FDA regulations in 

§§ 189.5(c)(6) and 700.27(c)(6), 

respectively, require that when filing for 

entry with U.S. Customs and Border 

Protection, the importer of record of 

human food or cosmetics manufactured 

from, processed with, or otherwise 

containing, cattle material must affirm 

that the human food or cosmetics were 

manufactured from, processed with, or 

otherwise contains, cattle material and 

must affirm that the human food or 

cosmetics were manufactured in 

accordance with the applicable 

requirements of §§ 189.5 or 700.27. In 

addition, if human food or cosmetics 

were manufactured from, processed 

with, or otherwise contains cattle 

material, the importer of record must 

provide within 5 business days records 

sufficient to demonstrate that the 

human food or cosmetics were not 

manufactured from, processed with, or 

otherwise contains prohibited cattle 

material, if requested. 

Under FDA’s regulations, we may 

designate a country from which cattle 

materials inspected and passed for 

human consumption are not considered 

prohibited cattle materials, and their use 

does not render human food or 

cosmetics adulterated. Sections 189.5(e) 

and 700.27(e) provide that a country 

seeking to be designated must send a 

written request to the Director of the 

Center for Food Safety and Applied 

Nutrition. The information the country 

is required to submit includes 

information about a country’s BSE case 

history, risk factors, measures to prevent 

the introduction and transmission of 

BSE, and any other information relevant 

to determining whether SRMs, the small 

intestine of cattle not otherwise 

excluded from being a prohibited cattle 

material, material from nonambulatory 

disabled cattle, or MS beef from the 

country seeking designation should be 

considered prohibited cattle materials. 

We use the information to determine 

whether to grant a request for 

designation and to impose conditions if 

a request is granted. 

Sections 189.5 and 700.27 further 

state that countries designated under 

§§ 189.5(e) and 700.27(e) will be subject 

to future review by FDA to determine 

whether their designations remain 

appropriate. As part of this process, we 

may ask designated countries to confirm 

their BSE situation and the information 

submitted by them, in support of their 

original application, has remained 

unchanged. We may revoke a country’s 

designation if we determine that it is no 

longer appropriate. Therefore, 

designated countries may respond to 

periodic FDA requests by submitting 

information to confirm their 

designations remain appropriate. We 

use the information to ensure their 

designations remain appropriate. 

Description of Respondents: 

Respondents to this information 

collection include manufacturers, 

processors, and importers of FDAregulated human food, including dietary 

supplements, and cosmetics 

manufactured from, processed with, or 

otherwise containing material derived 


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Federal Register / Vol. 89, No. 18 / Friday, January 26, 2024 / Notices 5243 

from cattle, as well as, with regard to 

§§ 189.5(e) and 700.27(e), foreign 

governments seeking designation under 

those regulations. 

In the Federal Register of August 11, 

2023 (88 FR 54617), FDA published a 

60-day notice requesting public 

comment on the proposed collection of 

information. We received one comment 

that was not related to the PRA and 

therefore will not be addressed in this 

document. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR section; activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average burden per 

response Total hours 

189.5(c)(6) and 700.27(c)(6); affirmation of 

compliance.

54,825 1 54,825 0.033 (2 minutes) ............. 1,809 

189.5(e) and 700.27(e); request for designation.1 1 1 80 ...................................... 80 

189.5(e) and 700.27(e); response to request 

for review by FDA.

1 1 1 26 ...................................... 26 

Total ........................................................... ........................ ........................ ........................ ........................................... 1,915 

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

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

Type of respondent Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records 

Average burden per 

recordkeeper Total hours 

Domestic Facilities ............................................ 697 52 36,244 0.25 (15 minutes) ............. 9,061 

Foreign Facilities ............................................... 916 52 47,632 0.25 (15 minutes) ............. 11,908 

Total ........................................................... ........................ ........................ ........................ ........................................... 20,969 

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

Based on a review of the information 

collection since our last request for 

OMB approval, we have made no 

adjustments to our burden estimate. 

Dated: January 18, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–01586 Filed 1–25–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–N–6827] 

Advisory Committee; Vaccines and 

Related Biological Products Advisory 

Committee, Renewal 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; renewal of Federal 

advisory committee. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) is 

announcing the renewal of the Vaccines 

and Related Biological Products 

Advisory Committee by the 

Commissioner of Food and Drugs (the 

Commissioner). The Commissioner has 

determined that it is in the public 

interest to renew the Vaccines and 

Related Biological Products Advisory 

Committee for an additional 2 years 

beyond the charter expiration date. The 

new charter will be in effect until the 

December 31, 2025, expiration date. 

DATES: Authority for the Vaccines and 

Related Biological Products Advisory 

Committee will expire on December 31, 

2025, unless the Commissioner formally 

determines that renewal is in the public 

interest. 

FOR FURTHER INFORMATION CONTACT: 

Sussan Paydar, Division of Scientific 

Advisors and Consultants, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Silver Spring, 

MD 20993–0002, 202–657–8533, 

Sussan.Paydar@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Pursuant 

to 41 CFR 102–3.65 and approval by the 

Department of Health and Human 

Services and by the General Services 

Administration, FDA is announcing the 

renewal of the Vaccines and Related 

Biological Products Advisory 

Committee (the Committee). The 

Committee is a discretionary Federal 

advisory committee established to 

provide advice to the Commissioner. 

The Committee advises the 

Commissioner or designee in 

discharging responsibilities as they 

relate to helping to ensure safe and 

effective vaccines and related biological 

products for human use, and as 

required, any other product for which 

FDA has regulatory responsibility. 

The Committee reviews and evaluates 

data concerning the safety, 

effectiveness, and appropriate use of 

vaccines and related biological products 

which are intended for use in the 

prevention, treatment, or diagnosis of 

human diseases, and as required, any 

other products for which FDA has 

regulatory responsibility. The 

Committee also considers the quality 

and relevance of FDA’s research 

program, which provides scientific 

support for the regulation of these 

products and makes appropriate 

recommendations to the Commissioner. 

Pursuant to its charter, the Committee 

shall consist of a core of 15 voting 

members, including the Chairperson 

(the Chair). Members and the Chair are 

selected by the Commissioner or 

designee from among authorities 

knowledgeable in the fields of 

immunology, molecular biology, rDNA, 

virology, bacteriology, epidemiology or 

biostatistics, vaccine policy, vaccine 

safety science, federal immunization 

activities, vaccine development 

including translational and clinical 

evaluation programs, hypersensitivity 

reactions to the vaccines, preventive 

medicine, infectious diseases, 

pediatrics, microbiology, and 

biochemistry. Members will be invited 


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