77866 Federal Register / Vol. 89, No. 185 / Tuesday, September 24, 2024 / Notices 

other aspect of this collection of 

information, including the necessity and 

utility of the proposed information 

collection for the proper performance of 

the agency’s functions, the accuracy of 

the estimated burden, ways to enhance 

the quality, utility, and clarity of the 

information to be collected, and the use 

of automated collection techniques or 

other forms of information technology to 

minimize the information collection 

burden. 

DATES: Comments on the collection(s) of 

information must be received by the 

OMB desk officer by October 24, 2024. 

ADDRESSES: Written comments and 

recommendations for the proposed 

information collection should be sent 

within 30 days of publication of this 

notice to www.reginfo.gov/public/do/ 

PRAMain. Find this particular 

information collection by selecting 

‘‘Currently under 30-day Review—Open 

for Public Comments’’ or by using the 

search function. 

To obtain copies of a supporting 

statement and any related forms for the 

proposed collection(s) summarized in 

this notice, please access the CMS PRA 

website by copying and pasting the 

following web address into your web 

browser: https://www.cms.gov/ 

Regulations-and-Guidance/Legislation/ 

PaperworkReductionActof1995/PRAListing. 

FOR FURTHER INFORMATION CONTACT: 

William Parham at (410) 786–4669. 

SUPPLEMENTARY INFORMATION: Under the 

Paperwork Reduction Act of 1995 (PRA) 

(44 U.S.C. 3501–3520), federal agencies 

must obtain approval from the Office of 

Management and Budget (OMB) for each 

collection of information they conduct 

or sponsor. The term ‘‘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 publish a 30-day notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension or 

reinstatement of an existing collection 

of information, before submitting the 

collection to OMB for approval. To 

comply with this requirement, CMS is 

publishing this notice that summarizes 

the following proposed collection(s) of 

information for public comment: 

1. Type of Information Collection 

Request: Extension of a currently 

approved collection; Title of 

Information Collection: Program 

Integrity: Exchange, Premium 

Stabilization Programs, and Market 

Standards; Amendments to the HHS 

Notice of Benefit and Payment 

Parameters for 2014; Final Rule II; Use: 

On March 23, 2010, the Patient 

Protection and Affordable Care Act 

(PPACA; Pub. L. 111–148) was signed 

into law and on March 30, 2010, the 

Health Care and Education 

Reconciliation Act of 2010 (Pub. L. 111– 

152) was signed into law. The two laws 

implement various health insurance 

policies. On June 19, 2013, the 

Department of Health and Human 

Services (HHS) published proposed rule 

CMS–9957–P: Program Integrity: 

Exchanges, SHOP, Premium 

Stabilization Programs, and Market 

Standards (78 FR 37302) (Program 

Integrity Proposed Rule) which, among 

other things, contained third party 

disclosure requirements and data 

collections that supported the oversight 

of premium stabilization programs, 

State Exchanges, and qualified health 

plan (QHP) issuers in Federallyfacilitated Exchanges (FFEs). Parts of the 

proposed rule were finalized as Patient 

Protection and Affordable Care Act; 

Program Integrity: Exchange, Premium 

Stabilization Programs, and Market 

Standards; Amendments to the HHS 

Notice of Benefit and Payment 

Parameters for 2014; Final Rule 

(Program Integrity Final Rule II), 78 FR 

25326 (October 24, 2013). This ICR 

relates to a portion of the information 

collection request (ICR) requirements set 

forth in the final rule. Form Number: 

CMS–10516 (OMB control number: 

0938–1277); Frequency: Annually; 

Affected Public: Private Sector, State, 

Local, or Tribal Governments; Business 

or other for-profits, and Not-for-Profits; 

Number of Respondents: 457; Number 

of Responses: 457; Total Annual Hours: 

42,771. (For questions regarding this 

collection, contact Andrea Honig at 

(301) 492–4147.) 

William N. Parham, III, 

Director, Division of Information Collections 

and Regulatory Impacts, Office of Strategic 

Operations and Regulatory Affairs. 

[FR Doc. 2024–21732 Filed 9–23–24; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2015–E–2079] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; BRAVECTO; Correction 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; correction. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) 

published a notice in the Federal 

Register of February 12, 2018, for the 

determination of the regulatory review 

period for the animal drug BRAVECTO. 

In accordance with the Court’s order in 

Nissan Chemical Corp., et al. v. FDA, et 

al., No. 22–01598 (D.D.C), this 

document revises the SUPPLEMENTARY

INFORMATION section of that notice by 

adjusting the start date of the testing 

phase for BRAVECTO. This notice 

supersedes the June 11, 2021, Federal 

Register document revising the 

February 12, 2018, notice. 

FOR FURTHER INFORMATION CONTACT: 

Beverly Friedman, Office of Regulatory 

Policy, Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 51, 

Rm. 6250, Silver Spring, MD 20993, 

301–796–3600. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of February 12, 2018 

(83 FR 6033), in FR Doc. 2018–02761, in 

the first column, the first two 

paragraphs under the section ‘‘II. 

Determination of Regulatory Review 

Period,’’ the following revision is made 

on page 6034: 

FDA has determined that the 

applicable regulatory review period for 

BRAVECTO is 1,548 days. Of this time, 

1,510 days occurred during the testing 

phase of the regulatory review period, 

while 38 days occurred during the 

approval phase. These periods of time 

were derived from the following dates: 

1. The date an exemption under 

section 512(j) of the Federal Food, Drug, 

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

360b(j)) became effective: February 19, 

2010. Pursuant to the Court’s order in 

Nissan Chemical Corp., et al. v. FDA, et 

al., No. 22–01598 (D.D.C), the start date 

of the testing phase for BRAVECTO was 

February 19, 2010. 

Dated: September 19, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–21841 Filed 9–23–24; 8:45 am] 

BILLING CODE 4164–01–P 


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