80116 Federal Register / Vol. 85, No. 239 / Friday, December 11, 2020 / Notices 

Pathway; Guidance for Industry and 

Food and Drug Administration Staff’’ 

(document number 19008), ‘‘Orthopedic 

Non-Spinal Metallic Bone Screws and 

Washers—Performance Criteria for 

Safety and Performance Based Pathway; 

Guidance for Industry and Food and 

Drug Administration Staff’’ (document 

number 19009), or ‘‘Magnetic Resonance 

(MR) Receive-only Coil—Performance 

Criteria for Safety and Performance 

Based Pathway; Guidance for Industry 

and Food and Drug Administration 

Staff’’ (document number 19011) may 

send an email request to CDRHGuidance@fda.hhs.gov to receive an 

electronic copy of the document. Please 

use the document number and complete 

title to identify the guidance you are 

requesting. 

III. Paperwork Reduction Act of 1995 

While these guidances contain no 

collection of information, they do 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 these 

guidances. The previously approved 

collections of information are subject to 

review by OMB under the PRA. The 

collections of information in the 

following FDA regulations and guidance 

have been approved by OMB as listed in 

the following table: 

21 CFR part or guidance Topic OMB control No. 

807, subpart E .......................................................................................................... Premarket notification ............................ 0910–0120 

‘‘Requests for Feedback on Medical Device Submissions: The Pre-Submission 

Program and Meetings with Food and Drug Administration Staff‘‘.

Q-submissions ....................................... 0910–0756 

Dated: December 7, 2020. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2020–27248 Filed 12–10–20; 8:45 am] 

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DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA- 2019–N–4203] 

Advisory Committee; Bone, 

Reproductive and Urologic Drugs 

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 Bone, Reproductive and 

Urologic Drugs 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 Bone, 

Reproductive and Urologic Drugs 

Advisory Committee for an additional 2 

years beyond the charter expiration 

date. The new charter will be in effect 

until the March 23, 2022, expiration 

date. 

DATES: Authority for the Bone, 

Reproductive and Urologic Drugs 

Advisory Committee will expire on 

March 23, 2022 unless the 

Commissioner formally determines that 

renewal is in the public interest. 

FOR FURTHER INFORMATION CONTACT: 

Kalyani Bhatt, 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: BRUDAC@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Pursuant 

to 41 CFR 102–3.65 and approval by the 

Department of Health and Human 

Services pursuant to 45 CFR part 11 and 

by the General Services Administration, 

FDA is announcing the renewal of the 

Bone, Reproductive and Urologic Drugs 

Advisory Committee. The Committee is 

a discretionary Federal advisory 

committee established to provide advice 

to the Commissioner. 

The Bone, Reproductive and Urologic 

Drugs Advisory Committee advises the 

Commissioner or designee in 

discharging responsibilities as they 

relate to helping to ensure safe and 

effective drugs for human use and, as 

required, any other product for which 

FDA has regulatory responsibility. 

The Committee reviews and evaluates 

data on the safety and effectiveness of 

marketed and investigational human 

drug products for use in the practice of 

osteoporosis and metabolic bone 

disease, obstetrics, gynecology, urology 

and related specialties, and makes 

appropriate recommendations to the 

Commissioner. 

Under its Charter, the Committee 

shall consist of a core of 11 voting 

members including the Chair. Members 

and the Chair are selected by the 

Commissioner or designee from among 

authorities knowledgeable in the fields 

of osteoporosis and metabolic bone 

disease, obstetrics, gynecology, urology, 

pediatrics, epidemiology, or statistics 

and related specialties. Members will be 

invited to serve for overlapping terms of 

up to 4 years. Almost all non-Federal 

members of this committee serve as 

Special Government Employees. The 

core of voting members may include one 

technically qualified member, selected 

by the Commissioner or designee, who 

is identified with consumer interests 

and is recommended by either a 

consortium of consumer-oriented 

organizations or other interested 

persons. In addition to the voting 

members, the Committee may include 

one non-voting representative member 

who is identified with industry 

interests. There may also be an alternate 

industry representative. 

Further information regarding the 

most recent charter and other 

information can be found at https://

www.fda.gov/advisory-committees/ 

human-drug-advisory-committees/bonereproductive-and-urologic-drugsadvisory-committee-formerlyreproductive-health-drugs-advisory or 

by contacting the Designated Federal 

Officer (see FOR FURTHER INFORMATION

CONTACT). In light of the fact that no 

change has been made to the Committee 

name or description of duties, no 

amendment will be made to 21 CFR 

14.100. 

This document is issued under the 

Federal Advisory Committee Act (5 

U.S.C. app.). For general information 

related to FDA advisory committees, 

please check https://www.fda.gov/ 

AdvisoryCommittees/default.htm. 

Dated: December 8, 2020. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2020–27289 Filed 12–10–20; 8:45 am] 

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