Federal Register / Vol. 86, No. 1 / Monday, January 4, 2021 / Notices 109 

TABLE 3—CDRH GUIDANCES AND COLLECTIONS—Continued 

COVID–19 guidance title 

Citation 

referenced in 

COVID–19 

guidance 

Another guidance referenced 

in COVID–19 guidance 

OMB control 

No(s). 

New collection covered by 

PHE PRA waiver 

Emergency Use Authorization 

of Medical Products and Related Authorities; Guidance 

for Industry and Other 

Stakeholders.

0910–0595 

Updates to FDA every 6 weeks 

after initial notification on the 

shortage situation. 

Voluntary submission of other 

information. 

Enforcement Policy for Bioburden Reduction Systems Using 

Dry Heat to Support Single-User Reuse of Certain Filtering 

Facepiece Respirators During the Coronavirus Disease 

2019 (COVID–19) Public Health Emergency (November 

2020).

......................... Emergency Use Authorization 

of Medical Products and Related Authorities; Guidance 

for Industry and Other 

Stakeholders.

0910–0595 

Labeling of the bioburden reduction system. 

Enforcement Policy for the Quality Standards of the Mammography Quality Standards Act [MQSA] During the COVID–19 

Public Health Emergency (December 2020).

21 CFR Part 

900.

.................................................. 0910–0309 

Document the time period that 

the facility was temporarily 

closed and present information during the facility’s 

MQSA inspection. 

Document and provide the circumstances re: lack of medical physicist survey within 

14 months of the last annual 

survey. 

Information on inability to meet 

the survey timeframes described in the guidance. 

Provide documentation of the 

dates and events that led to 

noncompliance and that facility will ensure compliance 

as soon as possible after 

COVID–19 restrictions are 

lifted. 

IV. Electronic Access 

Persons with access to the internet 

may obtain COVID–19-related guidances 

at: 

• FDA web page entitled ‘‘COVID–19- 

Related Guidance Documents for 

Industry, FDA Staff, and Other 

Stakeholders,’’ available at https://

www.fda.gov/emergency-preparednessand-response/mcm-issues/covid-19- 

related-guidance-documents-industryfda-staff-and-other-stakeholders; 

• FDA web page entitled ‘‘Search for 

FDA Guidance Documents’’ available at 

https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments; or 

• https://www.regulations.gov. 

Dated: December 29, 2020. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2020–29058 Filed 12–31–20; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–1414] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Class II Special 

Controls Guidance Document: 

Labeling Natural Rubber Latex 

Condoms 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing an opportunity for public 

comment on the proposed collection of 

certain information by the Agency. 

Under the Paperwork Reduction Act of 

1995 (PRA), Federal Agencies are 

required to publish notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, and 

to allow 60 days for public comment in 

response to the notice. This notice 

solicits comments on the information 

collection for the labeling of natural 

rubber latex condoms. 

DATES: Submit either electronic or 

written comments on the collection of 

information by March 5, 2021. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. Electronic comments must 

be submitted on or before March 5, 

2021. The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of March 5, 2021. Comments 

received by mail/hand delivery/courier 

(for written/paper submissions) will be 

considered timely if they are 

postmarked or the delivery service 

acceptance receipt is on or before that 

date. 

Electronic Submissions 

Submit electronic comments in the 

following way: 

110 Federal Register / Vol. 86, No. 1 / Monday, January 4, 2021 / Notices 

• 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–N–1414 for ‘‘Agency Information 

Collection Activities; Proposed 

Collection; Comment Request; Class II 

Special Controls Guidance Document: 

Labeling Natural Rubber Latex 

Condoms.’’ Received comments, those 

filed in a timely manner (see 

ADDRESSES), 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. 

FOR FURTHER INFORMATION CONTACT: 

JonnaLynn Capezzuto, Office of 

Operations, Food and Drug 

Administration, Three White Flint 

North, 10A–12M, 11601 Landsdown St., 

North Bethesda, MD 20852, 301–796– 

3794, PRAStaff@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3521), Federal 

Agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘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 (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

Agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Class II Special Controls Guidance 

Document: Labeling for Natural Rubber 

Latex Condoms—21 CFR 884.5300 OMB 

Control Number 0910–0633—Extension 

Under the Medical Device 

Amendments of 1976 (Pub. L. 94–295), 

class II devices were defined as those 

devices for which there was insufficient 

information to show that general 

controls themselves would provide a 

reasonable assurance of safety and 

effectiveness but for which there was 

sufficient information to establish 

performance standards to provide such 

assurance. Accordingly, FDA has 

established the above captioned Special 

Controls Guidance Document regarding 

the labeling of natural rubber latex 

condoms. 

Condoms without spermicidal 

lubricant containing nonoxynol 9 are 

classified in class II. They were 

originally classified before the 

enactment of provisions of the Safe 

Medical Devices Act of 1990 (Pub. L. 

101–629), which broadened the 

definition of class II devices and now 

permits FDA to establish special 

controls beyond performance standards, 

including guidance documents, to help 

provide reasonable assurance of the 

safety and effectiveness of such devices. 

In December 2000, Congress enacted 

Public Law 106–554, which directed 

FDA to ‘‘reexamine existing condom 

labels’’ and ‘‘determine whether the 

labels are medically accurate regarding 

the overall effectiveness or lack of 

effectiveness in preventing sexually 

transmitted diseases . . . .’’ In 

response, FDA recommended labeling 

intended to provide important 

information for condom users, including 

the extent of protection provided by 

condoms against various types of 

sexually transmitted diseases. 

Federal Register / Vol. 86, No. 1 / Monday, January 4, 2021 / Notices 111 

Respondents to this collection of 

information are manufacturers and 

repackagers of male condoms made of 

natural rubber latex without spermicidal 

lubricant. FDA expects approximately 

five new manufacturers or repackagers 

to enter the market yearly and to 

collectively have a third-party 

disclosure burden of 60 hours. The 

average burden per disclosure was 

derived from a study performed for FDA 

by Eastern Research Group, Inc., an 

economic consulting firm, to estimate 

the impact of the 1999 over-the-counter 

(OTC) human drug labeling 

requirements final rule (64 FR 13254, 

March 17, 1999). Because the packaging 

requirements for condoms are similar to 

those of many OTC drugs, we believe 

the burden to design the labeling for 

OTC drugs is an appropriate proxy for 

the estimated burden to design condom 

labeling. 

The special controls guidance 

document also refers to previously 

approved collections of information 

found in FDA regulations. The 

collections of information in 21 CFR 

part 801 have been approved under 

OMB control number 0910–0485; the 

collections of information in 21 CFR 

part 807, subpart E have been approved 

under OMB control number 0910–0120; 

and the collections of information in 21 

CFR part 820 have been approved under 

OMB control number 0910–0073. 

The collection of information under 

21 CFR 801.437 does not constitute a 

‘‘collection of information’’ under the 

PRA. Rather, it is a ‘‘public disclosure 

of information originally supplied by 

the Federal Government to the recipient 

for the purpose of disclosure to the 

public’’ (5 CFR 1320.3(c)(2)). 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1

Activity Number of 

respondents 

Number of 

disclosures per 

respondent 

Total 

annual 

disclosures 

Average 

burden per 

disclosure 

Total 

hours 

‘‘Class II Special Controls Guidance Document: Labeling 

for Natural Rubber Latex Condoms Classified Under 

21 CFR 884.5300’’ ......................................................... 5 1 5 12 60 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

Based on a review of the information 

collection since our last request for 

OMB approval, we have made no 

adjustments to our burden estimate. 

Dated: December 29, 2020. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2020–29091 Filed 12–31–20; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Toxicology Program Board of 

Scientific Counselors; Announcement 

of Meeting; Request for Comments 

AGENCY: National Institutes of Health, 

HHS. 

ACTION: Notice. 

SUMMARY: This notice announces the 

next meeting of the National Toxicology 

Program (NTP) Board of Scientific 

Counselors (BSC). The BSC, a federally 

chartered, external advisory group 

composed of scientists from the public 

and private sectors, will review and 

provide advice on programmatic 

activities. This meeting is a virtual 

meeting and is open to the public. 

Written comments will be accepted and 

registration is required to present oral 

comments. Information about the 

meeting and registration is available at 

https://ntp.niehs.nih.gov/go/165. 

DATES: 

Meeting: Scheduled for February 2, 

2021, 12:30 p.m.–5:00 p.m. Eastern 

Standard Time (EST). Written Public 

Comment Submissions: Deadline is 

January 26, 2021. 

Registration for Oral Comments: 

Deadline is January 26, 2021. 

ADDRESSES: 

Meeting Web page: The preliminary 

agenda, registration, and other meeting 

materials are available at https://

ntp.niehs.nih.gov/go/165. 

Virtual Meeting: The URL for viewing 

the virtual meeting will be provided on 

the meeting web page. 

FOR FURTHER INFORMATION CONTACT: Dr. 

Sheena Scruggs, Designated Federal 

Official for the BSC, Office of Liaison, 

Policy and Review, Division of NTP, 

NIEHS, P.O. Box 12233, K2–03, 

Research Triangle Park, NC 27709. 

Phone: 984–287–3355, Fax: 301–451– 

5759, Email: sheena.scruggs@nih.gov. 

Hand Deliver/Courier address: 530 

Davis Drive, Room K2130, Morrisville, 

NC 27560. 

SUPPLEMENTARY INFORMATION: The BSC 

will provide input to the NTP on 

programmatic activities and issues. The 

preliminary agenda topics include 

presentations from two of the Division 

of the National Toxicology Program 

(DNTP)’s research program areas. The 

preliminary agenda, roster of BSC 

members, background materials, public 

comments, and any additional 

information, when available, will be 

posted on the BSC meeting web page 

(https://ntp.niehs.nih.gov/go/165) or 

may be requested in hardcopy from the 

Designated Federal Official for the BSC. 

Following the meeting, summary 

minutes will be prepared and made 

available on the BSC meeting web page. 

Meeting Attendance Registration: The 

meeting is open to the public with time 

scheduled for oral public comments. 

Registration is not required to view the 

virtual meeting; the URL for the virtual 

meeting is provided on the BSC meeting 

web page (https://ntp.niehs.nih.gov/go/ 

165). TTY users should contact the 

Federal TTY Relay Service at 800–877– 

8339. Requests should be made at least 

five business days in advance of the 

event. 

Written Public Comments: NTP 

invites written public comments. 

Guidelines for public comments are 

available at https://ntp.niehs.nih.gov/ 

ntp/about_ntp/guidelines_public_

comments_508.pdf. 

The deadline for submission of 

written comments is January 26, 2021. 

Written public comments should be 

submitted through the meeting web 

page. Persons submitting written 

comments should include name, 

affiliation, mailing address, phone, 

email, and sponsoring organization (if 

any). Written comments received in 

response to this notice will be posted on 

the NTP web page, and the submitter 

will be identified by name, affiliation, 

and sponsoring organization (if any). 

Oral Public Comment Registration: 

The agenda allows for two formal public 

comment periods—one comment period 

for each program area (up to 3 

commenters, up to 5 minutes per 

speaker, per topic). Persons wishing to