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Milligrams, Were Not Withdrawn From 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withdrawn from sale for reasons of 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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41968 Federal Register / Vol. 82, No. 170 / Tuesday, September 5, 2017 / Notices 

Dated: August 28, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–18693 Filed 9–1–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–E–4282] 

Providing Regulatory Submissions in 

Electronic Format—Content of the Risk 

Evaluation and Mitigation Strategies 

Document Using Structured Product 

Labeling; Draft Guidance for Industry; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a draft 

guidance for industry entitled 

‘‘Providing Regulatory Submissions in 

Electronic Format—Content of the Risk 

Evaluation and Mitigation Strategies 

Document Using Structured Product 

Labeling.’’ This draft guidance is being 

issued in accordance with the Food and 

Drug Administration Safety and 

Innovation Act (FDASIA), which 

amended the Federal Food, Drug, and 

Cosmetic Act (the FD&C Act) to require 

that certain submissions under the 

FD&C Act and the Public Health Service 

Act (PHS Act) be submitted in 

electronic format, beginning no earlier 

than 24 months after issuance of final 

guidance on electronic format for 

submissions. The draft guidance 

describes how FDA plans to implement 

the requirements for the electronic 

submission of Risk Evaluation and 

Mitigation Strategies (REMS) documents 

in certain submissions under new drug 

applications, abbreviated new drug 

applications, and biologics license 

applications, beginning no earlier than 

24 months after issuance of the final 

guidance. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by March 5, 2018 to ensure that the 

Agency considers your comment on this 

draft guidance before it begins work on 

the final version of the guidance. 

ADDRESSES: You may submit comments 

on any guidance at any time as follows: 

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– 

2017–E–4282] for ’’ Providing 

Regulatory Submissions in Electronic 

Format—Content of the Risk Evaluation 

and Mitigation Strategies Document 

Using Structured Product Labeling; 

Draft Guidance for Industry; 

Availability.’’ Received comments 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 office 

between 9 a.m. and 4 p.m., Monday 

through Friday. 

• 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.gpo.gov/ 

fdsys/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. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). Submit written requests 

for single copies of the draft guidance to 

the Division of Drug Information, Center 

for Drug Evaluation and Research, Food 

and Drug Administration, 10001 New 

Hampshire Ave., Hillandale Building, 

4th Floor, Silver Spring, MD 20993– 

0002; or to the Office of 

Communication, Outreach and 

Development, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 3128, 

Silver Spring, MD 20993–0002. Send 

one self-addressed adhesive label to 

assist that office in processing your 

requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Adam Kroetsch, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, Bldg. 51, Rm. 

1168, 10903 New Hampshire Ave., 

Silver Spring, MD 20993–0002, 301– 

796–3842; or Aaron Sherman, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, Bldg. 51, Rm. 

mstockstill on DSK30JT082PROD with NOTICES