Federal Register / Vol. 85, No. 234 / Friday, December 4, 2020 / Notices 78337 

(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 for meetings related to 

generic drug development have been 

approved under OMB control number 

0910–0797.’’ 

Dated: November 30, 2020. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2020–26691 Filed 12–3–20; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2019–D–4739] 

Requesting FDA Feedback on 

Combination Products; Guidance for 

Industry and FDA Staff; 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 and FDA staff 

entitled ‘‘Requesting FDA Feedback on 

Combination Products.’’ The purpose of 

this guidance is to discuss ways in 

which combination product sponsors 

can obtain feedback from FDA on 

scientific and regulatory questions and 

to describe best practices for FDA and 

sponsors when interacting on these 

topics. These interactions can occur 

through application-based mechanisms, 

such as the pre-submission process used 

in the Center for Devices and 

Radiological Health (CDRH) and the 

Center for Biologics Evaluation and 

Research (CBER) and the formal 

meetings used in the Center for Drug 

Evaluation and Research (CDER) and 

CBER, or through Combination Product 

Agreement Meetings (CPAMs), as 

appropriate. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on December 4, 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– 

2019–D–4739 for ‘‘Requesting FDA 

Feedback on Combination Products.’’ 

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 

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 the guidance to the to the 

Office of Combination Products, Food 

and Drug Administration, Bldg. 32, Rm. 

5129, 10903 New Hampshire Ave., 

Silver Spring, MD 20993. Send one selfaddressed 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: 

Melissa Burns, Office of Combination 

Products, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 32, Rm. 5125, 301–796– 

5616, melissa.burns@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance for industry entitled 

‘‘Requesting FDA Feedback on 

Combination Products.’’ The purpose of 

this guidance is to discuss ways in 

which combination product sponsors 

can obtain feedback from the Agency on 

scientific and regulatory questions. 

These interactions can occur through 

application-based mechanisms, such as 

the pre-submission process used in 

78338 Federal Register / Vol. 85, No. 234 / Friday, December 4, 2020 / Notices 

CDRH and CBER and the formal 

meetings used in CDER and CBER, or 

through CPAMs, as appropriate. 

FDA is publishing this guidance 

consistent with the Agency’s ongoing 

commitment to enhancing clarity and 

transparency regarding regulatory 

considerations for combination 

products, and in accordance with the 

mandate under section 503(g)(8)(C)(vi) 

of the Federal Food, Drug, and 

Cosmetics Act (FD&C Act) (21 U.S.C. 

353(g)(8)(C)(vi)), which was added by 

section 3038 of the 21st Century Cures 

Act (Pub. L. 114–255). Section 

503(g)(8)(C)(vi) of the FD&C Act requires 

FDA to issue a final guidance 

addressing: (1) The structured process 

for managing pre-submission 

interactions with sponsors developing 

combination products; (2) best practices 

to ensure FDA feedback in such presubmission interactions represents the 

Agency’s best advice based on the 

information provided during these presubmission interactions; and (3) how 

CPAMs relate to other FDA meeting 

types, what information should be 

submitted prior to a CPAM, and the 

form and content of agreements reached 

through a CPAM. 

In response to comments received on 

the draft guidance, this final guidance 

includes additional information on use 

of CPAMs and application-based 

mechanisms. The guidance also 

provides additional clarity on how 

CPAMs will be conducted, including 

expected timelines for CPAM-related 

activities. 

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 ‘‘Requesting FDA 

Feedback on Combination Products.’’ 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 pertaining to orphan drug 

provisions in 21 CFR part 316 are 

approved under OMB control number 

0910–0167; the collections of 

information pertaining to investigational 

device exemption submission 

provisions in 21 CFR part 812 are 

approved under OMB control number 

0910–0078; the collections of 

information pertaining to investigational 

new drug submission provisions in 21 

CFR part 312 are approved under OMB 

control number 0910–0014; the 

collections of information pertaining to 

biologics licensing submission 

provisions in 21 CFR part 601 are 

approved under OMB control number 

0910–0338; and the collections of 

information pertaining to combination 

product agreement meetings are 

approved under OMB control number 

0910–0523. 

III. Electronic Access 

Persons with access to the internet 

may obtain the guidance at either 

https://www.fda.gov/combinationproducts/guidance-regulatoryinformation/combination-productsguidance-documents or https://

www.regulations.gov. 

Dated: November 30, 2020. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2020–26700 Filed 12–3–20; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–1768] 

Advisory Committee; Pharmacy 

Compounding Advisory Committee; 

Renewal 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; renewal of advisory 

committee. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

renewal of the Pharmacy Compounding 

Advisory Committee by the 

Commissioner of Food and Drugs (the 

Commissioner). The Commissioner has 

determined that it is in the public 

interest to renew the Pharmacy 

Compounding Advisory Committee for 

an additional 2 years beyond the charter 

expiration date. The new charter will be 

in effect until April 25, 2022. 

DATES: Authority for the Pharmacy 

Compounding Advisory Committee will 

expire on April 25, 2022, unless the 

Commissioner formally determines that 

renewal is in the public interest. 

FOR FURTHER INFORMATION CONTACT: 

Yvette Waples, Division of Advisory 

Committee and Consultant 

Management, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 31, Rm. 2417, 

Silver Spring, MD 20993–0002, 301– 

796–9001, email: PCAC@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Pursuant 

to 41 CFR 102–3, FDA is announcing 

the renewal of the Pharmacy 

Compounding Advisory Committee 

(Committee). The Committee is a nondiscretionary Federal advisory 

committee established to provide advice 

to the Commissioner. 

The Committee advises the 

Commissioner or designee in 

discharging responsibilities as they 

relate to compounding drugs for human 

use and, as required, any other product 

for which FDA has regulatory 

responsibility. 

The Committee shall provide advice 

on scientific, technical, and medical 

issues concerning drug compounding 

under sections 503A and 503B of the 

Federal Food, Drug, and Cosmetic Act 

(21 U.S.C. 353a and 353b), and, as 

required, any other product for which 

FDA has regulatory responsibility and 

make appropriate recommendations to 

the Commissioner of Food and Drugs. 

Pursuant to its Charter, the Committee 

shall consist of a core of 12 voting 

members including the Chair. Members 

and the Chair are selected by the 

Commissioner or designee from among 

authorities knowledgeable in the fields 

of pharmaceutical compounding, 

pharmaceutical manufacturing, 

pharmacy, medicine, and related 

specialties. These members will include 

representatives from the National 

Association of Boards of Pharmacy, the 

United States Pharmacopeia, 

pharmacists with current experience 

and expertise in compounding, 

physicians with background and 

knowledge in compounding, and patient 

and public health advocacy 

organizations. Members will be invited 

to serve for overlapping terms of up to 

four years. Almost all non-Federal 

members of this committee serve as 

Special Government Employees. The 

core of voting members may include one 

or more technically qualified members, 

selected by the Commissioner or 

designee, who are identified with 

consumer interests and are 

recommended by either a consortium of 

consumer-oriented organizations or 

other interested persons. In addition to 

the voting members, the Committee may 

include one or more non-voting 

representative members who are 

identified with industry interests. There