Federal Register / Vol. 89, No. 15 / Tuesday, January 23, 2024 / Notices 4315 

For further information about the Rare 

Pediatric Disease Priority Review 

Voucher Program and for a link to the 

full text of section 529 of the FD&C Act, 

go to https://www.fda.gov/ForIndustry/ 

DevelopingProductsforRareDiseases

Conditions/RarePediatric

DiseasePriorityVoucherProgram/ 

default.htm. For further information 

about XYWAV (calcium, magnesium, 

potassium, and sodium oxybates), go to 

the ‘‘Drugs@FDA’’ website at https:// 

www.accessdata.fda.gov/scripts/cder/ 

daf/. 

Dated: January 17, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–01156 Filed 1–22–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–5656] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; State Enforcement 

Notifications 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, the Agency, or 

we) 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 reporting 

requirements contained in existing FDA 

regulations governing State enforcement 

notifications. 

DATES: Either electronic or written 

comments on the collection of 

information must be submitted by 

March 25, 2024. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. The https://

www.regulations.gov electronic filing 

system will accept comments until 

11:59 p.m. Eastern Time at the end of 

March 25, 2024. Comments received by 

mail/hand delivery/courier (for written/ 

paper submissions) will be considered 

timely if they are received 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–5656 for ‘‘Agency Information 

Collection Activities; Proposed 

Collection; Comment Request; State 

Enforcement Notifications.’’ 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 

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, 10A–12M, 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. 


khammond on DSKJM1Z7X2PROD with NOTICES
4316 Federal Register / Vol. 89, No. 15 / Tuesday, January 23, 2024 / Notices 

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. 

State Enforcement Notifications—21 

CFR 100.2(d) 

OMB Control Number 0275—Extension 

This information collection supports 

Agency regulations. Specifically, section 

310(b) of the Federal Food, Drug, and 

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

337(b)) authorizes a State to enforce 

certain sections of the FD&C Act in their 

own name and within their own 

jurisdiction. However, before doing so, 

a State must provide notice to FDA 

according to § 100.2 (21 CFR 100.2). The 

information required in a letter of 

notification under § 100.2(d) enables us 

to identify the food against which a 

State intends to take action and to 

advise that State whether Federal 

enforcement action against the food has 

been taken or is in process. With certain 

narrow exceptions, Federal enforcement 

action precludes State action under the 

FD&C Act. 

We estimate 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 

100.2(d); notification ............................................................ 1 1 1 10 10 

1There are no capital costs 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. 

The estimated reporting burden for 

§ 100.2(d) is minimal because 

enforcement notifications are seldom 

used by States. During the last 3 years, 

we have not received any new 

enforcement notifications; therefore, we 

estimate that one or fewer notifications 

will be submitted annually. Although 

we have not received any new 

enforcement notifications in the last 3 

years, these information collection 

provisions should be extended to 

provide for the potential future need of 

a State government to submit 

enforcement notifications informing us 

when it intends to take enforcement 

action under the FD&C Act against a 

particular food located in the State. 

Dated: January 18, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–01238 Filed 1–22–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2024–N–0008] 

Request for Nominations From 

Industry Organizations Interested in 

Participating in the Selection Process 

for Nonvoting Industry 

Representatives and Request for 

Nominations for Nonvoting Industry 

Representatives on the Cellular, 

Tissue, and Gene Therapies Advisory 

Committee 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

requesting that any industry 

organizations interested in participating 

in the selection of a nonvoting industry 

representative to serve on the Cellular, 

Tissue, and Gene Therapies Advisory 

Committee (CTGTAC) for the Center for 

Biologics Evaluation and Research 

notify FDA in writing. FDA is also 

requesting nominations for a nonvoting 

industry representative(s) to serve on 

the CTGTAC. A nominee may either be 

self-nominated or nominated by an 

organization to serve as a nonvoting 

industry representative. Nominations 

will be accepted for current vacancies 

effective with this notice. 

DATES: Any industry organization 

interested in participating in the 

selection of an appropriate nonvoting 

member to represent industry interests 

must send a letter stating that interest to 

FDA by February 22, 2024 (see sections 

I and II of this document for further 

details). Concurrently, nomination 

materials for prospective candidates 

should be sent to FDA by February 22, 

2024. 

ADDRESSES: All statements of interest 

from industry organizations interested 

in participating in the selection process 

of nonvoting industry representative 

nominations should be sent via email to 

Cicely Reese or Marie DeGregorio (see 

FOR FURTHER INFORMATION CONTACT). All 

nominations for nonvoting industry 

representatives must be submitted 

electronically by accessing the FDA 

Advisory Committee Membership 

Nomination Portal at: https://www.

accessdata.fda.gov/scripts/FACTRS

Portal/FACTRS/index.cfm. Information 

about becoming a member of an FDA 

advisory committee can also be obtained 

by visiting FDA’s website at: https://

www.fda.gov/AdvisoryCommittees/ 

default.htm. 

FOR FURTHER INFORMATION CONTACT: 

Cicely Reese or Marie DeGregorio, 

Center for Biologics Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 71, Rm. 1232, Silver Spring, 

MD 20993–0002, 240–620–9987, email: 

CBERCTGTAC@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: The 

Agency intends to add a nonvoting 

industry representative(s) to the 

following advisory committee: 


khammond on DSKJM1Z7X2PROD with NOTICES