Federal Register / Vol. 86, No. 104 / Wednesday, June 2, 2021 / Notices 29585 

www.regulations.gov. Follow the 

instructions for ‘‘Comment or 

Submission’’ or ‘‘More Search Options’’ 

to find the information collection 

document(s) 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 C4–26–05, 

7500 Security Boulevard, Baltimore, 

Maryland 21244–1850. 

To obtain copies of a supporting 

statement and any related forms for the 

proposed collection(s) 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) 786–4669. 

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 collection’s supporting statement 

and associated materials (see 

ADDRESSES). 

CMS–10637 Marketplace Operations 

CMS–10501 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. 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 

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 

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: 

CMS–10637 (OMB control number 

0938–1353); 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 301–492–4400.) 

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 1128C(a)(2) of the Social 

Security Act (42 U.S.C. 1320a–7c(a)(2)) 

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 1128(C)(a)(1) 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.133—Consolidated Appropriations 

Act, 2021, which amended Section 

1128C(a) of the Social Security Act (42 

U.S.C. 1320a–7c(a)) 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 

execute the HFPP studies within the 

HFPP. Form Number: CMS–10501 

(OMB control number: 0938–1251); 

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 

(410–786–5942). 

Dated: May 27, 2021. 

William N. Parham, III, 

Director, Paperwork Reduction Staff, Office 

of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2021–11591 Filed 6–1–21; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–P–0163] 

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. 

SUMMARY: 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 20993–0002, 301–796–8363, 

Stacy.Kane@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 1984, 

Congress enacted the Drug Price 

Competition and Patent Term 

Restoration Act of 1984 (Pub. L. 98–417) 

(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 


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29586 Federal Register / Vol. 86, No. 104 / Wednesday, June 2, 2021 / Notices 

the drug for which they are seeking 

approval contains the same active 

ingredient in the same strength and 

dosage form as the ‘‘listed drug,’’ which 

is a version of the drug that was 

previously approved. ANDA applicants 

do not have to repeat the extensive 

clinical testing otherwise necessary to 

gain approval of a new drug application 

(NDA). 

The 1984 amendments include what 

is now section 505(j)(7) of the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 

355(j)(7)), which requires FDA to 

publish a list of all approved drugs. 

FDA publishes this list as part of the 

‘‘Approved Drug Products With 

Therapeutic Equivalence Evaluations,’’ 

which is known generally as the 

‘‘Orange Book.’’ Under FDA regulations, 

drugs are removed from the list if the 

Agency withdraws or suspends 

approval of the drug’s NDA or ANDA 

for reasons of safety or effectiveness or 

if FDA determines that the listed drug 

was withdrawn from sale for reasons of 

safety or effectiveness (21 CFR 314.162). 

A person may petition the Agency to 

determine, or the Agency may 

determine on its own initiative, whether 

a listed drug was withdrawn from sale 

for reasons of safety or effectiveness. 

This determination may be made at any 

time after the drug has been withdrawn 

from sale, but must be made prior to 

approving an ANDA that refers to the 

listed drug (§ 314.161 (21 CFR 314.161)). 

FDA may not approve an ANDA that 

does not refer to a listed drug. 

SANDOSTATIN (octreotide acetate) 

injection, EQ 0.2 mg base/mL and EQ 1 

mg base/mL, is the subject of NDA 

19667, held by Novartis 

Pharmaceuticals Corporation. NDA 

19667 was initially approved on 

October 21, 1988, and the EQ 0.2 mg 

base/mL and EQ 1 mg base/mL strengths 

were approved on June 12, 1991. 

SANDOSTATIN is indicated to reduce 

blood levels of growth hormone and 

IGF–I (somatomedin C) in acromegaly 

patients who have had inadequate 

response to or cannot be treated with 

surgical resection, pituitary irradiation, 

and bromocriptine mesylate at 

maximally tolerated doses. 

SANDOSTATIN is also indicated for the 

symptomatic treatment of patients with 

metastatic carcinoid tumors where it 

suppresses or inhibits the severe 

diarrhea and flushing episodes 

associated with the disease. 

SANDOSTATIN is also indicated for the 

treatment of profuse watery diarrhea 

associated with vasoactive intestinal 

peptide-secreting tumors. 

In a letter received by the Agency on 

May 11, 2020, Novartis Pharmaceuticals 

Corporation notified FDA that 

SANDOSTATIN (octreotide acetate) 

injection, EQ 0.2 mg base/mL and EQ 1 

mg base/mL, was being discontinued, 

and FDA moved the drug product to the 

‘‘Discontinued Drug Product List’’ 

section of the Orange Book. Caplin 

Steriles Limited submitted a citizen 

petition dated February 5, 2021 (Docket 

No. FDA–2021–P–0163), under 21 CFR 

10.30, requesting that the Agency 

determine whether SANDOSTATIN 

(octreotide acetate) injection, EQ 0.2 mg 

base/mL and EQ 1 mg base/mL, was 

withdrawn from sale for reasons of 

safety or effectiveness. 

After considering the citizen petition 

and reviewing Agency records and 

based on the information we have at this 

time, FDA has determined under 

§ 314.161 that SANDOSTATIN 

(octreotide acetate) injection, EQ 0.2 mg 

base/mL and EQ 1 mg base/mL, was not 

withdrawn for reasons of safety or 

effectiveness. The petitioner has 

identified no data or other information 

suggesting that SANDOSTATIN 

(octreotide acetate) injection, EQ 0.2 mg 

base/mL and EQ 1 mg base/mL, was 

withdrawn for reasons of safety or 

effectiveness. We have carefully 

reviewed our files for records 

concerning the withdrawal of 

SANDOSTATIN (octreotide acetate) 

injection, EQ 0.2 mg base/mL and EQ 1 

mg base/mL, from sale. We have also 

independently evaluated relevant 

literature and data for possible 

postmarketing adverse events. We have 

found no information that would 

indicate that this drug product was 

withdrawn from sale for reasons of 

safety or effectiveness. 

Accordingly, the Agency will 

continue to list SANDOSTATIN 

(octreotide acetate) injection, EQ 0.2 mg 

base/mL and EQ 1 mg base/mL, in the 

‘‘Discontinued Drug Product List’’ 

section of the Orange Book. The 

‘‘Discontinued Drug Product List’’ 

delineates, among other items, drug 

products that have been discontinued 

from marketing for reasons other than 

safety or effectiveness. FDA will not 

begin procedures to withdraw approval 

of approved ANDAs that refer to this 

drug product. Additional ANDAs for 

this drug product may also be approved 

by the Agency as long as they meet all 

other legal and regulatory requirements 

for the approval of ANDAs. If FDA 

determines that labeling for this drug 

product should be revised to meet 

current standards, the Agency will 

advise ANDA applicants to submit such 

labeling. 

Dated: May 26, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–11575 Filed 6–1–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Submission to OMB for 

Review and Approval; Public Comment 

Request; Rural Health Care 

Coordination Program Performance 

Improvement and Measurement 

System Database, OMB No. 0906– 

0024—Reinstate With Changes 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services (HHS). 

ACTION: Notice. 

SUMMARY: In compliance with the 

Paperwork Reduction Act of 1995, 

HRSA has submitted an Information 

Collection Request (ICR) to the Office of 

Management and Budget (OMB) for 

review and approval. Comments 

submitted during the first public review 

of this ICR will be provided to OMB. 

OMB will accept further comments from 

the public during the review and 

approval period. 

DATES: Comments on this ICR should be 

received no later than July 2, 2021. 

ADDRESSES: Submit your comments, 

including the ICR Title, to the desk 

officer for HRSA, either by email to 

OIRA_submission@omb.eop.gov or by 

fax to (202) 395–5806. 

FOR FURTHER INFORMATION CONTACT: To 

request a copy of the clearance requests 

submitted to OMB for review, email the 

HRSA Information Collection Clearance 

Officer at paperwork@hrsa.gov or call 

(301) 443–1984. 

SUPPLEMENTARY INFORMATION: When 

submitting comments or requesting 

information, please include the 

information request collection title for 

reference. 

Information Collection Request Title: 

Rural Health Care Coordination Program 

Performance Improvement and 

Measurement System Database, OMB 

No. 0906–0024—Reinstate with 

Changes. 

Abstract: The Rural Health Care 

Coordination (Care Coordination) 

program is authorized under Section 

330A(e) of the Public Health Service 

(PHS) Act (42 U.S.C. 254(e)), as 

amended, to ‘‘improve access and 


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