4314 Federal Register / Vol. 89, No. 15 / Tuesday, January 23, 2024 / Notices 

information collection. We further 

estimate the total time needed to 

prepare complete applications for 

diagnostic radiopharmaceuticals as 

approximately 6,000 hours. This 

information collection does not impose 

any additional reporting burden for 

safety and effectiveness information on 

diagnostic radiopharmaceuticals beyond 

the estimated burden of 2,000 hours, 

because safety and effectiveness 

information is already required in 

§ 314.50 and has been approved under 

OMB control number 0910–0001. In 

fact, clarification of our criteria for the 

evaluation of diagnostic 

radiopharmaceuticals in this 

information collection is intended to 

streamline overall information 

collection burdens, particularly for 

diagnostic radiopharmaceuticals that 

may have well-established, low-risk 

safety profiles by enabling 

manufacturers to tailor information 

submissions and avoid unnecessary 

clinical trials. 

In table 1, row 2, we estimate the 

annual reporting burden for preparing 

the safety and effectiveness sections of 

a supplement to an approved 

application. This estimate does not 

include the time needed to conduct 

studies and clinical trials or other 

research from which the reported 

information is obtained. 

Based on past submissions of human 

drug applications, new indication 

supplements for diagnostic 

radiopharmaceuticals, or both, we 

estimate that one submission will be 

received annually. We estimate the total 

time needed to prepare complete 

applications for supplements to new 

applications for diagnostic 

radiopharmaceuticals as approximately 

between 500 and 1,000 hours. We 

calculated the median of this estimate to 

arrive at approximately 750 hours. We 

further estimate that the total time 

needed to prepare the portions of the 

application that would be affected by 

this information collection as 750 hours. 

As previously stated, this information 

collection does not impose any 

additional reporting burden for safety 

and effectiveness information on 

diagnostic radiopharmaceuticals beyond 

the estimated burden of 750 hours 

because safety and effectiveness 

information is already required in 

§ 314.50 and has been approved under 

OMB control number 0910–0001. 

In the Federal Register of October 12, 

2023 (88 FR 70667), FDA published a 

60-day notice requesting public 

comment on the proposed collection of 

information. No comments were 

received. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN FOR NDAS AND SUPPLEMENTS TO APPROVED NDAS FOR

DIAGNOSTIC RADIOPHARMACEUTICALS1

Manufacturers’ activity (21 CFR section) Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

NDAs (§§ 315.4, 315.5, and 315.6) ................................... 3 1 3 2,000 6,000 

Supplements to Approved NDAs (§§ 315.4, 315.5, and 

315.6) ............................................................................. 1 1 1 750 750 

Total ............................................................................ ........................ .......................... ........................ ........................ 6,750 

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

Our estimated burden for the 

information collection reflects an 

overall decrease of 11 responses with a 

corresponding decrease of 12,000 

burden hours. We attribute this 

adjustment to a decrease in the number 

of submissions for NDAs for diagnostic 

radiopharmaceuticals and new 

indication supplements for diagnostic 

radiopharmaceuticals we received over 

the past few years. 

Dated: January 18, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–01237 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–2018–N–1262] 

Notice of Approval of Product Under 

Voucher: Rare Pediatric Disease 

Priority Review Voucher 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

issuance of approval of a product 

redeeming a priority review voucher. 

The Federal Food, Drug, and Cosmetic 

Act (FD&C Act) authorizes FDA to 

award priority review vouchers to 

sponsors of approved rare pediatric 

disease product applications that meet 

certain criteria. FDA is required to 

publish notice of the issuance of priority 

review vouchers as well as the approval 

of products redeeming a priority review 

voucher. FDA has determined that 

XYWAV (calcium, magnesium, 

potassium, and sodium oxybates), 

approved July 21, 2020, meets the 

criteria for redeeming a priority review 

voucher. 

FOR FURTHER INFORMATION CONTACT: 

Cathryn Lee, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Silver Spring, MD 20993–0002, 

301–796–1394, email: Cathryn.Lee@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: FDA is 

announcing the approval of a product 

redeeming a rare pediatric disease 

priority review voucher. Under section 

529 of the FD&C Act (21 U.S.C. 360ff), 

FDA will report the issuance of rare 

pediatric disease priority review 

vouchers and the approval of products 

for which a voucher was redeemed. 

FDA has determined that XYWAV 

(calcium, magnesium, potassium, and 

sodium oxybates) meets the redemption 

criteria. 


khammond on DSKJM1Z7X2PROD with NOTICES
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