Federal Register / Vol. 88, No. 182 / Thursday, September 21, 2023 / Notices 65173 

I. Background 

Menopause is often a time of 

tremendous transition and change for 

women. The effects of menopause on 

the PK and PD of drugs are largely 

unknown. Sex hormone changes during 

menopause may affect the metabolic 

pathways of drugs by affecting drug 

metabolizing enzymes. Hormone 

changes may also affect other pathways 

that play an important role for drug 

disposition and excretion. In addition, 

many women experience weight gain at 

menopause. Together, these changes 

associated with menopausal transition 

have the potential to affect the PK of 

medications used for indications not 

related to menopause. Furthermore, 

physiologic changes in menopause may 

result in altered sensitivity to drug 

response independent of changes in PK. 

This public workshop will provide 

insight into identifying the research and 

data gaps regarding the potential impact 

of menopause on PK/PD, highlighting 

areas with the greatest need for further 

research and exploration. 

II. Topics for Discussion at the Public 

Workshop 

This public workshop will include 

presentations and session discussions 

by experts in the fields of clinical 

pharmacology, obstetrics and 

gynecology, endocrinology, and clinical 

care. Each session will include a Q&A 

session to respond to questions from 

attendees. 

III. Participating in the Public 

Workshop 

Registration: To register for the public 

workshop, please visit the following 

website: https://www.fda.gov/ 

consumers/public-meetings-workshopsand-webinars/menopause-potentialimpact-clinical-pharmacology-andopportunities-future-research-10112023. 

Please provide complete contact 

information for each attendee, including 

name, title, affiliation, address, email, 

and telephone. 

Registration is free and based on 

space availability, with priority given to 

early registrants. Registrants will receive 

confirmation when they have been 

accepted. If you need special 

accommodations due to a disability, 

please contact Lisa Lineberger at 

OWHmeetings@fda.hhs.gov no later 

than October 10, 2023. 

Dated: September 18, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–20454 Filed 9–20–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2020–N–0908] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Submission of 

Petitions: Food Additive, Color 

Additive (Including Labeling), 

Submission of Information to a Master 

File in Support of Petitions; and 

Electronic Submission Using Food and 

Drug Administration Form 3503 

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 October 23, 

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 0910–0016. 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. 

Submission of Petitions: Food 

Additive, Color Additive (Including 

Labeling), Submission of Information to 

a Master File in Support of Petitions; 

and Electronic Submission Using Form 

FDA 3503–21 CFR 70.25, 71.1, and 

171.1 and 21 CFR parts 172, 173, 179, 

and 180 OMB Control Number 0910– 

0016—Extension. 

Section 409(a) of the Federal Food, 

Drug, and Cosmetic Act (FD&C Act) (21 

U.S.C. 348(a)) provides that a food 

additive shall be deemed to be unsafe, 

unless: (1) the additive and its use, or 

intended use, are in conformity with a 

regulation issued under section 409 that 

describes the condition(s) under which 

the additive may be safely used; (2) the 

additive and its use, or intended use, 

conform to the terms of an exemption 

for investigational use; or (3) a food 

contact notification submitted under 

section 409(h) is effective. Food 

Additive Petitions (FAPs) are submitted 

by individuals or companies to obtain 

approval of a new food additive or to 

amend the conditions of use permitted 

under an existing food additive 

regulation. Section 171.1 of FDA’s 

regulations (21 CFR 171.1) specifies the 

information that a petitioner must 

submit in order to establish that the 

proposed use of a food additive is safe 

and to secure the publication of a food 

additive regulation describing the 

conditions under which the additive 

may be safely used. Parts 172, 173, 179, 

and 180 (21 CFR parts 172, 173, 179, 

and 180) contain labeling requirements 

for certain food additives to ensure their 

safe use. 

Section 721(a) of the FD&C Act (21 

U.S.C. 379e(a)) provides that a color 

additive shall be deemed to be unsafe 

unless the additive and its use are in 

conformity with a regulation that 

describes the condition(s) under which 

the additive may safely be used, or the 

additive and its use conform to the 

terms of an exemption for 

investigational use issued under section 

721(f). Color Additive Petitions (CAPs) 

are submitted by individuals or 

companies to obtain approval of a new 

color additive or a change in the 

conditions of use permitted for a color 

additive that is already approved. 

Section 71.1 of the Agency’s regulations 

(21 CFR 71.1) specifies the information 

that a petitioner must submit to 

establish the safety of a color additive 

and to secure the issuance of a 

regulation permitting its use. FDA’s 

color additive labeling requirements in 

§ 70.25 (21 CFR 70.25) require that color 

additives that are to be used in food, 

drugs, cosmetics, or medical devices be 

labeled with sufficient information to 

ensure their safe use. 

FDA scientific personnel review FAPs 

to ensure the safety of the intended use 

of the additive in or on food, or that may 

be present in food as a result of its use 

in articles that contact food. Likewise, 

FDA personnel review CAPs to ensure 

the safety of the color additive prior to 

its use in food, drugs, cosmetics, or 

medical devices. 


ddrumheller on DSK120RN23PROD with NOTICES1
65174 Federal Register / Vol. 88, No. 182 / Thursday, September 21, 2023 / Notices 

Respondents may transmit FAP or 

CAP regulatory submissions in 

electronic format or paper format to the 

Office of Food Additive Safety in the 

Center for Food Safety and Applied 

Nutrition (CFSAN) using Form FDA 

3503. Form FDA 3503 helps the 

respondent organize their submission to 

focus on the information needed for 

FDA’s safety review. Form FDA 3503 

can also be used to organize information 

within a master file submitted in 

support of petitions according to the 

items listed on the form. Master files 

can be used as repositories for 

information that can be referenced in 

multiple submissions to the Agency, 

thus minimizing paperwork burden for 

food and color additive approvals. 

We improved the information 

collection by using the CFSAN Online 

Submission Module (COSM). COSM 

provides a real-time user interface 

process that assists respondents in 

preparing and making submissions to 

CFSAN. COSM is a web-based tool that 

supports electronic submissions, 

thereby eliminating the need for 

printing and mailing of paper 

submissions. COSM is available 24 

hours a day and 7 days a week. Further 

information about COSM, including 

user instruction, is available on the 

internet at: https://www.fda.gov/food/ 

registration-food-facilities-and-othersubmissions/cfsan-online-submissionmodule-cosm. 

Description of respondents: 

Respondents are businesses engaged in 

the manufacture or sale of food, food 

ingredients, color additives, or 

substances used in materials that come 

into contact with food. 

In the Federal Register of February 1, 

2023 (88 FR 6757), FDA published a 60- 

day notice requesting public comment 

on the proposed collection of 

information. Although one comment 

was received, it was not responsive to 

the four collection of information topics 

solicited. 

We estimate the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity/21 CFR section; or FDA form No. Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Total 

operating 

and 

maintenance 

costs 

Submission of Petitions: Color Additive 

Including Labeling—70.25 and 71.1 .... 2 1 2 1,337 2,674 $5,600 

Submission of Petitions: Food Additive 

Including Labeling—171.1 .................... 3 1 3 7,093 21,279 0 

Form FDA 3503 2 ..................................... 5 1 5 1 5 0 

Total .................................................. ........................ ........................ ........................ ........................ 23,958 5,600 

1There are no capital costs associated with this collection of information. 

2Form FDA 3503 is used for both CAPs and FAPs. 

We have adjusted our burden 

estimate, which has resulted in a 

decrease to the currently approved 

burden by 1 hour. Our estimate of 

burden attributable to FAPs or CAPs is 

based on our experience with the 

information collection, which has not 

changed since our last review, and 

reflects the average number of petitions 

we have received annually over a period 

of 10 years. The attendant burden we 

estimate also reflects an industry 

average, although burden associated 

with individual petitions may vary 

depending on the complexity of the 

petition, and the amount and type of 

data needed for scientific analysis. 

CAPs are subject to fees. The listing 

fee for a CAP ranges from $1,600 to 

$3,000, depending on the intended use 

of the color additive and the scope of 

the requested amendment. A complete 

schedule of fees is set forth in 21 CFR 

70.19. An average of one Category A and 

one Category B CAP is expected per 

year. The maximum CAP fee for a 

Category A petition is $2,600, and the 

maximum CAP fee for a Category B 

petition is $3,000. Because an average of 

two CAPs are expected per calendar 

year, the estimated total annual cost 

burden to petitioners for this startup 

cost would be less than or equal to 

$5,600 ((1 × $2,600) + (1 × $3,000) 

listing fees). There are no capital costs 

associated with CAPs. 

The labeling requirements for food 

and color additives were designed to 

specify the minimum information 

needed for labeling in order that food 

and color manufacturers may comply 

with all applicable provisions of the 

FD&C Act and other specific labeling 

Acts administered by FDA. Label 

information does not require any 

additional information gathering beyond 

what is already required to assure 

conformance with all specifications and 

limitations in any given food or color 

additive regulation. Label information 

does not have any specific 

recordkeeping requirements unique to 

preparing the label. Therefore, because 

labeling requirements under § 70.25 for 

a particular color additive involve 

information required as part of the CAP 

safety review process, the estimate for 

number of respondents is the same for 

§§ 70.25 and 71.1, and the burden hours 

for labeling are included in the estimate 

for § 71.1. Also, because labeling 

requirements under parts 172, 173, 179, 

and 180 for particular food additives 

involve information required as part of 

the FAP safety review process under 

§ 171.1, the burden hours for labeling 

are included in the estimate for § 171.1. 

Dated: September 18, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–20451 Filed 9–20–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–3742] 

Scientific Challenges and 

Opportunities To Advance the 

Development of Individualized Cellular 

and Gene Therapies; Request for 

Information 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; request for information 

and comments. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency), Center 

for Biologics Evaluation and Research 

(CBER) is requesting information from 

stakeholders regarding critical scientific 


ddrumheller on DSK120RN23PROD with NOTICES1