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Federal Register / Vol. 86, No. 104 / Wednesday, June 2, 2021 / Notices
jbell on DSKJLSW7X2PROD with NOTICES

www.regulations.gov. Follow the instructions for Comment or Submission or More Search Options to find the information collection documents that are accepting comments.
2. By regular mail. You may mail written comments to the following address: CMS, Office of Strategic Operations and Regulatory Affairs, Division of Regulations Development, Attention: Document Identifier/OMB
Control Number: ll, Room C42605, 7500 Security Boulevard, Baltimore, Maryland 212441850.
To obtain copies of a supporting statement and any related forms for the proposed collections summarized in this notice, you may make your request using one of following:
1. Access CMS website address at website address at https www.cms.gov/
Regulations-and-Guidance/Legislation/
PaperworkReductionActof1995/PRAListing.html.
FOR FURTHER INFORMATION CONTACT:
William N. Parham at 410 7864669.
SUPPLEMENTARY INFORMATION:
Contents This notice sets out a summary of the use and burden associated with the following information collections. More detailed information can be found in each collections supporting statement and associated materials see ADDRESSES.
CMS10637 Marketplace Operations CMS10501 Healthcare Fraud Prevention Partnership HFPP Data Sharing and Information Exchange Under the 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. 35023 and 5 CFR
1320.3c and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party.
Section 3506c2A of the PRA
requires federal agencies to publish a 60-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.
Information Collection 1. Type of Information Collection Request: Extension of a currently approved collection; Title of
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Information Collection: Marketplace Operations; Use: The data collections and third-party disclosure requirements will assist HHS in determining Exchange compliance with Federal standards and monitoring QHP issuers in FFEs for compliance with Federal QHP issuer standards. The data collection will also assist HHS in monitoring Web-brokers for compliance with Federal Web-broker standards. The data collected by health insurance issuers and Exchanges will help to inform HHS, Exchanges, and health insurance issuers as to the participation of individuals, employers, and employees in the individual Exchange, the SHOP, and the premium stabilization programs. Form Number:
CMS10637 OMB control number 09381353; Frequency: Annually;
Affected Public: Private sector Business or other for-profits; Number of Respondents: 3,902; Total Annual Responses: 3,902; Total Annual Hours:
2,336,190. For policy questions regarding this collection contact:
Nikolas Berkobien at 3014924400.
2. Type of Information Collection Request: Revision of a currently approved collection; Title of Information Collection: Healthcare Fraud Prevention Partnership HFPP
Data Sharing and Information Exchange;
Use: Section 1128Ca2 of the Social Security Act 42 U.S.C. 1320a7ca2
authorizes the Secretary and the Attorney General to consult, and arrange for the sharing of data with, representatives of health plans for purposes of establishing a Fraud and Abuse Control Program as specified in Section 1128Ca1 of the Social Security Act. The result of this authority has been the establishment of the HFPP.
The HFPP was officially established by a Charter in the fall of 2012 and signed by HHS Secretary Sibelius and US
Attorney General Holder. In December 2020, President Trump signed into law H.R.133Consolidated Appropriations Act, 2021, which amended Section 1128Ca of the Social Security Act 42
U.S.C. 1320a7ca providing explicit statutory authority for the Healthcare Fraud Prevention Partnership including the potential expansion of the publicprivate partnership analyses.
Data sharing within the HFPP
primarily focuses on conducting studies for the purpose of combatting fraud, waste, and abuse. These studies are intended to target specific vulnerabilities within the payment systems in both the public and private healthcare sectors. The HFPP and its committees design and develop studies in coordination with the TTP. The core function of the TTP is to manage and
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execute the HFPP studies within the HFPP. Form Number: CMS10501
OMB control number: 09381251;
Frequency: Occasionally; Affected Public: Private sector Business or other for-profits; Number of Respondents: 28;
Number of Responses: 28; Total Annual Hours: 120. For questions regarding this collection, contact Marnie Dorsey at 4107865942.
Dated: May 27, 2021.
William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs.
FR Doc. 202111591 Filed 6121; 8:45 am BILLING CODE 412001P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration Docket No. FDA2021P0163

Determination That SANDOSTATIN
Octreotide Acetate Injection, Equal to 0.2 Milligrams Base/Milliliter and Equal to 1 Milligrams Base/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY:

Food and Drug Administration,
HHS.
ACTION:

Notice.

The Food and Drug Administration FDA, Agency, or we has determined that SANDOSTATIN
octreotide acetate injection, equal to EQ 0.2 milligrams mg base/milliliter mL and 1 mg base/mL, was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications ANDAs that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.
FOR FURTHER INFORMATION CONTACT:
Stacy Kane, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6236, Silver Spring, MD 209930002, 3017968363, Stacy.Kane@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price Competition and Patent Term Restoration Act of 1984 Pub. L. 98417
the 1984 amendments, which authorized the approval of duplicate versions of drug products under an ANDA procedure. ANDA applicants must, with certain exceptions, show that SUMMARY:

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