41966 Federal Register / Vol. 82, No. 170 / Tuesday, September 5, 2017 / Notices 

explaining the development of their 

QBP status. The technical report is 

provided in writing by electronic mail 

to the MA organization. If, after 

reviewing the technical report, the MA 

organization believes that CMS was 

incorrect in its QBP determination, 

within 10 calendar days the MA 

organization may request an appeal to 

be conducted by a hearing officer 

designated by CMS. The hearing 

officer’s decision is final and binding on 

both the MA organization and CMS. The 

hearing officer is required to issue his/ 

her decision on or before May 15 of the 

year preceding the year in which the 

contract for which the QBP to be 

applied will be offered. Form Number: 

CMS–10346 (OMB control number: 

0938–1129); Frequency: Yearly; Affected 

Public: Private sector (Business or other 

for-profits and Not-for-profit 

institutions); Number of Respondents: 

500; Total Annual Responses: 20; Total 

Annual Hours: 160. (For policy 

questions regarding this collection 

contact Sarah Gaillot at 410–786–4637). 

Dated: August 30, 2017. 

William N. Parham, III, 

Director, Paperwork Reduction Staff, Office 

of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2017–18740 Filed 9–1–17; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifiers: CMS–102 and CMS– 

105, and CMS–10631] 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request 

AGENCY: Centers for Medicare & 

Medicaid Services, HHS. 

ACTION: Notice. 

SUMMARY: The Centers for Medicare & 

Medicaid Services (CMS) is announcing 

an opportunity for the public to 

comment on CMS’ intention to collect 

information from the public. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), federal agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information (including each proposed 

extension or reinstatement of an existing 

collection of information) and to allow 

60 days for public comment on the 

proposed action. Interested persons are 

invited to send comments regarding our 

burden estimates or any 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 must be received by 

November 6, 2017. 

ADDRESSES: When commenting, please 

reference the document identifier or 

OMB control number. To be assured 

consideration, comments and 

recommendations must be submitted in 

any one of the following ways: 

1. Electronically. You may send your 

comments electronically to http://

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 _________, 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’ Web site address at 

http://www.cms.hhs.gov/ 

PaperworkReductionActof1995. 

2. Email your request, including your 

address, phone number, OMB number, 

and CMS document identifier, to 

Paperwork@cms.hhs.gov. 

3. Call the Reports Clearance Office at 

(410) 786–1326. 

FOR FURTHER INFORMATION CONTACT: 

William 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–102 and CMS–105 Clinical Laboratory 

Improvement Amendments of 1988 (CLIA) 

Budget Workload Reports and Supporting 

Regulations 

CMS–10631 The PACE Organization 

Application Process in 42 CFR part 460 

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 without change of a 

currently approved collection; Title of 

Information Collection: Clinical 

Laboratory Improvement Amendments 

of 1988 (CLIA) Budget Workload 

Reports and Supporting Regulations; 

Use: We will use the collected 

information to determine the amount of 

Federal reimbursement for surveys 

conducted. Use of the information 

includes program evaluation, audit, 

budget formulation and budget 

approval. Form CMS–102 is a multipurpose form designed to capture and 

record all budget and expenditure data. 

Form CMS–105 captures the annual 

projected CLIA workload that the State 

survey agency will accomplish. Our 

regional offices also use the information 

to approve the annual projected CLIA 

workload. The information is required 

as part of the section 1864 agreement 

with the state. Form Numbers: CMS–102 

and CMS–105 (OMB control number: 

0938–0599); Frequency: Quarterly; 

Affected Public: State, Local, or Tribal 

Governments; Number of Respondents: 

50; Total Annual Responses: 50; Total 

Annual Hours: 1,700. (For policy 

questions regarding this collection 

contact Jeffrey Pleines at 410–786– 

0684.) 

2. Type of Information Collection 

Request: Revision of a currently 

approved collection; Title of 

Information Collection: The PACE 

Organization Application Process in 42 

CFR part 460; Use: Initial application 

requirements for the PACE program are 

currently set forth in 42 CFR 460.12 and 

in the PACE Manual, Ch. 17. Until 

recently, the submission of initial and 

SAE PACE applications and supporting 

information was in paper format. These 

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Federal Register / Vol. 82, No. 170 / Tuesday, September 5, 2017 / Notices 41967 

applications are often hundreds of pages 

long, expensive to reproduce and 

transmit, and administratively 

inefficient, as staff reviewing different 

parts of the application are located in 

different physical locations and must 

receive hard copies of the material. 

However, beginning in 2016 and 2017, 

initial and SAE PACE applications, 

respectively, are being submitted via a 

new automated, electronic submission 

process. As with initial applications, an 

application also must be submitted for 

a PO that seeks to expand its service 

area and/or add a new service site, and 

with OMB approval, an automated 

application process will now also be 

required of PACE organizations 

submitting service area expansion 

applications. The collection specific to 

the application was approved by OMB 

for a 3-year period, which expires 

March 31, 2020. Approval is now 

requested for revisions to this currentlyapproved collection, which includes 

modifications to the PACE application. 

Form Number: CMS–10631 (OMB 

control number: 0938–1326); Frequency: 

Once and occasionally; Affected Public: 

Private sector (Business or other forprofits and Not-for-profit institutions) 

and State, Local, or Tribal Governments; 

Number of Respondents: 730; Total 

Annual Responses: 84; Total Annual 

Hours: 4,626. (For policy questions 

regarding this collection contact Stacy 

Davis at 410–786–7813.) 

Dated: August 30, 2017. 

William N. Parham, III, 

Director, Paperwork Reduction Staff, Office 

of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2017–18738 Filed 9–1–17; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–P–1459] 

Determination That ENJUVIA 

(Estrogens, Conjugated Synthetic B) 

Tablets, 0.625 Milligrams and 1.25 

Milligrams, Were 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 or Agency) has 

determined that ENJUVIA (estrogens, 

conjugated synthetic B) tablets, 0.625 

milligrams (mg) and 1.25 mg, were not 

withdrawn from sale for reasons of 

safety or effectiveness. This 

determination will allow FDA to 

approve abbreviated new drug 

applications (ANDAs) for ENJUVIA 

(estrogens, conjugated synthetic B) 

tablets, 0.625 mg and 1.25 mg, if all 

other legal and regulatory requirements 

are met. 

FOR FURTHER INFORMATION CONTACT: 

Bronwen Blass, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 6228, 

Silver Spring, MD 20993–0002, 301– 

796–5092. 

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 

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. 

ENJUVIA (estrogens, conjugated 

synthetic B) tablets, 0.625 mg and 1.25 

mg, is the subject of NDA 021443, held 

by Teva Branded Pharmaceutical 

Products R&D, Inc. (Teva), and was 

initially approved on May 10, 2004. 

ENJUVIA is indicated for treatment of 

moderate to severe vasomotor symptoms 

due to menopause and treatment of 

moderate to severe vaginal dryness and 

pain with intercourse, as well as 

symptoms of vulvar and vaginal atrophy 

due to menopause. 

In 2016, Teva notified FDA that 

ENJUVIA (estrogens, conjugated 

synthetic B) tablets, 0.625 mg and 1.25 

mg, were being discontinued, and FDA 

moved those drug products to the 

‘‘Discontinued Drug Product List’’ 

section of the Orange Book. 

Foley & Lardner submitted a citizen 

petition dated March 8, 2017 (Docket 

No. FDA–2017–P–1459), under 21 CFR 

10.30, requesting that the Agency 

determine whether ENJUVIA (estrogens, 

conjugated synthetic B) tablets, 0.625 

mg and 1.25 mg, were 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 ENJUVIA (estrogens, 

conjugated synthetic B) tablets, 0.625 

mg and 1.25 mg, were not withdrawn 

for reasons of safety or effectiveness. 

The petitioner has identified no data or 

other information suggesting that these 

products were withdrawn for reasons of 

safety or effectiveness. We have 

carefully reviewed our files for records 

concerning the withdrawal of ENJUVIA 

(estrogens, conjugated synthetic B) 

tablets, 0.625 mg and 1.25 mg, 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 these drug products were 

withdrawn from sale for reasons of 

safety or effectiveness. 

Accordingly, the Agency will 

continue to list ENJUVIA (estrogens, 

conjugated synthetic B) tablets, 0.625 

mg and 1.25 mg, 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. 

ANDAs that refer to ENJUVIA 

(estrogens, conjugated synthetic B) 

tablets, 0.625 mg and 1.25 mg, may 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. 

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