Federal Register / Vol. 88, No. 188 / Friday, September 29, 2023 / Notices 67303 

immunocompetent donor cells 

recognizing and reacting to disparity 

with major or minor histocompatibility 

antigens on recipient tissues. The 

classical approach to prevention of 

GVHD involves pharmacological or 

physical methods to delete alloreactive 

T cells in the immediate peritransplant 

setting with or without additional drugs 

to prevent activation of naive T cells. 

Should aGVHD or cGVHD occur despite 

these measures, treatment has depended 

largely on drugs that impair T cells. 

Further basic science investigations 

have elucidated the molecular 

mechanisms behind the clinical 

manifestations of aGVHD and cGVHD, 

including cytokines, the innate immune 

system, and components of the adaptive 

immune system other than T cells. 

These scientific advances have provided 

opportunities for development of 

biomarkers to identify the specific 

immune dysfunction present in an 

individual patient and for development 

of drugs to modulate the immune 

system with precision rather than to just 

suppress the immune system globally. 

Given the complexity of the clinical 

manifestation of aGVHD and cGVHD 

and the potential for a paradigm shift in 

the management of GVHD, this guidance 

provides recommendations regarding 

the design and conduct of clinical trials 

and the types of supporting data that 

could facilitate efficient development of 

drugs and/or certain devices for the 

prevention or treatment of aGVHD or 

cGVHD. This guidance also provides 

recommendations on what should be 

included in the marketing application to 

facilitate review. 

This draft guidance is being issued 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The draft guidance, when finalized, will 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 ‘‘Graft-versus-Host Diseases: 

Developing Drugs, Biological Products, 

and Certain Devices for Prevention or 

Treatment.’’ 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 

While this guidance contains no 

collection of information, it does refer to 

previously approved FDA collections of 

information. The previously approved 

collections of information are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501– 

3521). The collections of information in 

21 CFR part 312 have been approved 

under OMB control number 0910–0014; 

the collections of information in 21 CFR 

part 314 have been approved under 

OMB control number 0910–0001; the 

collections of information in 21 CFR 

part 601 have been approved under 

OMB control number 0910–0338; the 

collections of information in 21 CFR 

part 812 have been approved under 

OMB control number 0910–0078; and 

the collections of information in 21 CFR 

parts 50 and 56 have been approved 

under OMB control number 0910–0130. 

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/ 

vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics/biologics-guidances, https://

www.fda.gov/regulatory-information/ 

search-fda-guidance-documents, or 

https://www.regulations.gov. 

Dated: September 26, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–21524 Filed 9–28–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2022–D–0814] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Infant Formula 

Recalls 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, the Agency, or 

we) 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 October 30, 

2023. 

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 

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 0910–0256. Also include 

the FDA docket number found in 

brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Domini Bean, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–5733, 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. 

Infant Formula Requirements Under 

the Federal Food, Drug, and Cosmetic 

Act—21 CFR Parts 106 and 107 

OMB Control Number 0910–0256— 

Revision 

This information collection supports 

FDA regulations, and associated Agency 

forms and guidance, pertaining to infant 

formula requirements. Statutory 

provisions for infant formula under the 

Federal Food, Drug, and Cosmetic Act 

(FD&C Act) were enacted to protect the 

health of infants and include specific 

current good manufacturing practice, 

labeling (disclosure), and a number of 

reporting and recordkeeping 

requirements. Section 412 of the FD&C 

Act (21 U.S.C. 350a) requires 

manufacturers of infant formula to 

establish and document the adherence 

to quality control procedures, notify 

FDA when a batch of infant formula that 

has left the manufacturers’ control may 

be adulterated or misbranded, and keep 

records of infant formula distribution. 

Notification requirements are also 

included in the regulations regarding 

the quantitative formulation of the 

infant formula; a description of any 

reformulation or change in processing; 

assurances that the formula will not be 

marketed until regulatory requirements 

are met as demonstrated by specific 

testing; and assurances that 

manufacturing processes comply with 

the regulations. The regulations are 

found in 21 CFR part 106: Infant 

Formula Requirements Pertaining to 

Current Good Manufacturing Practice, 

Quality Control Procedures, Quality 

Factors, Records and Reports, and 

Notifications; and part 107 (21 CFR part 

107): Infant Formula. 

In the Federal Register of October 6, 

2022 (87 FR 60689), we provided notice 

communicating updates to the 

information collection and invited 

public comment on the proposed 


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67304 Federal Register / Vol. 88, No. 188 / Friday, September 29, 2023 / Notices 

collections of information. No 

comments were received. On our own 

initiative, for efficiency of Agency 

operations, we are again revising the 

information collection to include related 

activities applicable to regulations in 

part 107, subpart E (21 CFR 107.200 

through 107.280) pertaining to infant 

formula recalls. These information 

collections are currently approved in 

OMB control number 0910–0188. 

Specifically, 21 CFR 107.230 requires 

manufacturing firms conducting infant 

formula recalls to: 

(1) evaluate the hazard to human 

health; 

(2) devise a written recall strategy; 

(3) promptly notify each affected 

direct account (customer) about the 

recall; and 

(4) furnish the appropriate FDA 

district office with copies of these 

documents. 

If the recalled formula presents a risk 

to human health, the recalling firm must 

also request that each establishment that 

sells the recalled formula post (at point 

of purchase) a notice of the recall and 

provide FDA with a copy of the notice. 

Similarly, Agency regulations in 21 

CFR 107.240 require recalling firms to: 

(1) notify the appropriate FDA district 

office of the recall by telephone within 

24 hours; 

(2) submit a written report to that 

office within 14 days; and 

(3) submit a written status report at 

least every 14 days until the recall is 

terminated. Before terminating a recall, 

recalling firms are required to submit a 

recommendation for termination of the 

recall to the appropriate FDA district 

office and wait for written FDA 

concurrence (21 CFR 107.250). Where 

the recall strategy or implementation is 

determined to be deficient, FDA may 

require the firm to change the extent of 

the recall, carry out additional 

effectiveness checks, and issue 

additional notifications (21 CFR 

107.260). Finally, to facilitate 

identifying the location of the product 

being recalled, the recalling firm is 

required to maintain distribution 

records for at least 1 year after the 

expiration of the shelf life of the infant 

formula (§ 107.280 (21 CFR 107.280)). 

We estimate the burden of the 

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 

107.230; Elements of infant formula recall .......................... 2 1 2 4,450 8,900 

107.240; Notification requirements ...................................... 2 1 2 1,482 2,964 

107.250; Termination of infant formula recall ...................... 2 1 2 120 240 

107.260; Revision of an infant formula recall ...................... 1 1 1 625 625 

Total .............................................................................. ........................ ........................ ........................ ........................ 12,729 

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

The reporting and third-party 

disclosure burden estimates are based 

on current available data showing eight 

manufacturers of infant formula and 

that there have been, on average, two 

infant formula recalls per year for the 

past 3 years. Under 5 CFR 1320.3(b)(2), 

the time, effort, and financial resources 

necessary to comply with a collection of 

information are excluded from the 

burden estimate if the reporting, 

recordkeeping, or disclosure activities 

needed to comply are usual and 

customary because they would occur in 

the normal course of activities. 

Accordingly, because we believe that 

associated records are maintained as a 

usual and customary part of normal 

business activities, we include no 

separate burden estimate for 

recordkeeping requirements found in 

§ 107.280. 

TABLE 2—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1

21 CFR section; activity Number of 

respondents 

Number of 

disclosures 

per 

respondent 

Total annual 

disclosures 

Average 

burden per 

disclosure 

Total hours 

107.230; Elements of infant formula recall .......................... 2 1 2 50 100 

107.260; Revision of an infant formula recall ...................... 1 1 1 25 25 

Total .............................................................................. ........................ ........................ ........................ ........................ 125 

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

Although we have increased the 

number of respondents to the 

information collection since our last 

request for OMB approval, we have 

made no adjustments to the burden we 

estimate for the time necessary to 

complete activities associated with 

infant formula recalls. 

Dated: September 26, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–21432 Filed 9–28–23; 8:45 am] 

BILLING CODE 4164–01–P 


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