81928 Federal Register / Vol. 85, No. 243 / Thursday, December 17, 2020 / Notices 

INFORMATION section for electronic 

access to the draft guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Wiley A. Chambers, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Avenue, Bldg. 22, Rm. 6108, 

Silver Spring, MD 20993, 301–796– 

0690. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Dry Eye: Developing Drugs for 

Treatment.’’ Dry eye disease is a 

common condition, particularly in older 

individuals. Signs and symptoms of dry 

eye disease can cause interference with 

activities of daily living. This draft 

guidance document, once finalized, will 

help developers of treatments for dry 

eye disease efficiently develop drugs to 

treat dry eye conditions. 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the current thinking of FDA 

on ‘‘Dry Eye: Developing Drugs for 

Treatment.’’ It does not establish any 

rights for any person and is not binding 

on FDA or the public. You can use an 

alternative approach if it satisfies the 

requirements of the applicable statutes 

and regulations. 

II. Paperwork Reduction Act of 1995 

While this guidance contains no 

collection of information, it does refer to 

previously approved FDA collections of 

information. Therefore, clearance by the 

Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995 (PRA) (44 U.S.C. 3501– 

3521) is not required for this guidance. 

The previously approved collections of 

information are subject to review by 

OMB under the PRA. The collections of 

information in 21 CFR parts 312 and 

314 have been approved under OMB 

control numbers 0910–0014 and 0910– 

0001, respectively. 

III. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at either 

https://www.fda.gov/drugs/guidancecompliance-regulatory-information/ 

guidances-drugs or https://

www.regulations.gov. 

Dated: December 14, 2020. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2020–27762 Filed 12–16–20; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–D–1167] 

Controlled Correspondence Related to 

Generic Drug Development; 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 final 

guidance for industry entitled 

‘‘Controlled Correspondence Related to 

Generic Drug Development.’’ This 

guidance provides information 

regarding the process by which generic 

drug manufacturers and related industry 

can submit controlled correspondence 

to FDA requesting information related to 

generic drug development and the 

Agency’s process for providing 

communications related to such 

correspondence. This guidance also 

describes the process by which generic 

drug manufacturers and related industry 

can submit requests to clarify 

ambiguities in FDA’s controlled 

correspondence response and the 

Agency’s process for responding to 

those requests. This guidance finalizes 

the draft guidance announced in the 

Federal Register on November 3, 2017, 

and replaces the guidance for industry 

‘‘Controlled Correspondence Related to 

Generic Drug Development’’ issued in 

September 2015. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on December 17, 2020. 

ADDRESSES: You may submit either 

electronic or written comments on 

Agency guidances 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– 

2014–D–1167 for ‘‘Controlled 

Correspondence Related to Generic Drug 

Development.’’ 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 between 9 

a.m. and 4 p.m., Monday through 

Friday, 240–402–7500. 

• 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 

Federal Register / Vol. 85, No. 243 / Thursday, December 17, 2020 / Notices 81929 

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.govinfo.gov/content/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, 240–402–7500. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). 

Submit written requests for single 

copies of this 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. 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: Lisa 

Bercu, Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Silver Spring, MD 20993–0002, 

240–402–6902. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance for industry entitled 

‘‘Controlled Correspondence Related to 

Generic Drug Development.’’ This 

guidance provides information 

regarding the process by which generic 

drug manufacturers and related industry 

can submit to FDA controlled 

correspondence requesting information 

related to generic drug development and 

the Agency’s process for providing 

communications related to such 

correspondence. This guidance also 

describes the process by which generic 

drug manufacturers and related industry 

can submit requests to clarify 

ambiguities in FDA’s controlled 

correspondence response and the 

Agency’s process for responding to 

those requests. 

In accordance with the Generic Drug 

User Fee Amendments (GDUFA) 

Reauthorization Performance Goals and 

Program Enhancements Fiscal Years 

2018–2022 (GDUFA II Goals Letter or 

GDUFA II Commitment Letter), FDA 

agreed to certain review goals and 

procedures for the review of controlled 

correspondence received both before 

and on or after October 1, 2017. The 

GDUFA II Commitment Letter also 

defines standard controlled 

correspondence and complex controlled 

correspondence, and the guidance 

provides additional details and 

recommendations concerning what 

inquiries FDA considers controlled 

correspondence for the purposes of 

meeting the Agency’s GDUFA II 

commitment. In addition, the guidance 

provides details and recommendations 

concerning what information requestors 

should include in a controlled 

correspondence to facilitate FDA’s 

consideration of and response to the 

controlled correspondence and what 

information FDA will provide in its 

communications to requestors that have 

submitted controlled correspondence. 

The GDUFA II Commitment Letter also 

states that FDA will review and respond 

to requests to clarify ambiguities in the 

controlled correspondence response, 

and the guidance provides information 

on how requestors may submit these 

requests and the Agency’s process for 

responding to them. 

This guidance finalizes the draft 

guidance announced in the Federal 

Register on November 3, 2017 (82 FR 

51277), and replaces the guidance for 

industry ‘‘Controlled Correspondence 

Related to Generic Drug Development’’ 

issued in September 2015. The Agency 

considered comments on the draft 

guidance while finalizing the guidance. 

Revisions include clarification on FDA’s 

practices regarding controlled 

correspondence that is related to a 

pending petition, what information 

should be submitted with a request 

related to an inactive ingredient, and 

when FDA may determine an inquiry is 

a complex controlled correspondence. 

We also revised the guidance to 

recommend that requestors submit their 

controlled correspondence through the 

CDER Direct NextGen Collaboration 

Portal. 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the current 

thinking of FDA on ‘‘Controlled 

Correspondence Related to Generic Drug 

Development.’’ It does not establish any 

rights for any person and is not binding 

on FDA or the public. You can use an 

alternative approach if it satisfies the 

requirements of the applicable statutes 

and regulations. 

II. Paperwork Reduction Act of 1995 

While this guidance contains no 

collection of information, it does refer to 

previously approved FDA collections of 

information. Therefore, clearance by the 

Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995 (44 U.S.C. 3501–3521) is not 

required for this guidance. The 

previously approved collections of 

information are subject to review by 

OMB under the PRA. The collections of 

information in 21 CFR part 314 have 

been approved under OMB control 

number 0910–0797. 

III. Electronic Access 

Persons with access to the internet 

may obtain the guidance at either 

https://www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/ 

Guidances/default.htm or https://

www.regulations.gov. 

Dated: December 14, 2020. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2020–27810 Filed 12–16–20; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2020–N–0026] 

Issuance of Priority Review Voucher; 

Rare Pediatric Disease Product 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

issuance of a priority review voucher to 

the sponsor of a rare pediatric disease 

product application. The Federal Food, 

Drug, and Cosmetic Act (FD&C Act) 

authorizes FDA to award priority review 

vouchers to sponsors of approved rare 

pediatric disease product applications 

that meet certain criteria. FDA is 

required to publish notice of the award 

of the priority review voucher. FDA has 

determined that IMCIVREE 

(setmelanotide) injection, manufactured 

by Rhythm Pharmaceuticals, Inc., meets 

the criteria for a priority review 

voucher. 

FOR FURTHER INFORMATION CONTACT: 

Althea Cuff, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Silver Spring, MD 20993–0002, 

301–796–4061, Fax: 301–796–9856, 

email: althea.cuff@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: FDA is 

announcing the issuance of a priority 

review voucher to the sponsor of an