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 

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

make an oral comment are required to 

register online at https://

ntp.niehs.nih.gov/go/165 by January 26, 

2021. Oral comments will be received 

only during the formal comment periods 

indicated on the preliminary agenda. 

Oral comments will only be by 

teleconference line. The access number 

for the teleconference line will be 

provided to registrants by email prior to 

the meeting. Registration is on a firstcome, first-served basis. Each 

organization is allowed one time slot 

per topic. After the maximum number of 

speakers per comment period is 

exceeded, individuals registered to 

provide oral comment will be placed on 

a wait list and notified should an 

opening become available. Commenters 

will be notified approximately one week 

before the meeting about the actual time 

allotted per speaker. 

If possible, oral public commenters 

should send a copy of their slides and/ 

or statement or talking points to NTPMeetings@icf.com by January 26, 2021. 

Meeting Materials: The preliminary 

meeting agenda is available on the 

meeting web page (https://

ntp.niehs.nih.gov/go/165) and will be 

updated one week before the meeting. 

Individuals are encouraged to access the 

meeting web page to stay abreast of the 

most current information regarding the 

meeting. 

Background Information on the BSC: 

The BSC is a technical advisory body 

comprised of scientists from the public 

and private sectors that provides 

primary scientific oversight to the NTP. 

Specifically, the BSC advises the NTP 

on matters of scientific program content, 

both present and future, and conducts 

periodic review of the program for the 

purpose of determining and advising on 

the scientific merit of its activities and 

their overall scientific quality. Its 

members are selected from recognized 

authorities knowledgeable in fields such 

as toxicology, pharmacology, pathology, 

epidemiology, risk assessment, 

carcinogenesis, mutagenesis, cellular 

biology, computational toxicology, 

neurotoxicology, genetic toxicology, 

reproductive toxicology or teratology, 

and biostatistics. Members serve 

overlapping terms of up to four years. 

The BSC usually meets periodically. 

The authority for the BSC is provided by 

42 U.S.C. 217a, section 222 of the Public 

Health Service Act (PHS), as amended. 

The BSC is governed by the 

provisions of the Federal Advisory 

Committee Act, as amended (5 U.S.C. 

app.), which sets forth standards for the 

formation and use of advisory 

committees. 

Dated: December 29, 2020. 

Brian R. Berridge, 

Associate Director, National Toxicology 

Program. 

[FR Doc. 2020–29079 Filed 12–31–20; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Substance Abuse and Mental Health 

Services Administration 

Current List of HHS-Certified 

Laboratories and Instrumented Initial 

Testing Facilities Which Meet Minimum 

Standards To Engage in Urine and Oral 

Fluid Drug Testing for Federal 

Agencies 

AGENCY: Substance Abuse and Mental 

Health Services Administration, HHS. 

ACTION: Notice. 

SUMMARY: The Department of Health and 

Human Services (HHS) notifies federal 

agencies of the laboratories and 

Instrumented Initial Testing Facilities 

(IITFs) currently certified to meet the 

standards of the Mandatory Guidelines 

for Federal Workplace Drug Testing 

Programs using Urine or Oral Fluid 

(Mandatory Guidelines). 

FOR FURTHER INFORMATION CONTACT: 

Anastasia Donovan, Division of 

Workplace Programs, SAMHSA/CSAP, 

5600 Fishers Lane, Room 16N06B, 

Rockville, Maryland 20857; 240–276– 

2600 (voice); Anastasia.Donovan@

samhsa.hhs.gov (email). 

SUPPLEMENTARY INFORMATION: A notice 

listing all currently HHS-certified 

laboratories and IITFs is published in 

the Federal Register during the first 

week of each month. If any laboratory or 

IITF certification is suspended or 

revoked, the laboratory or IITF will be 

omitted from subsequent lists until such 

time as it is restored to full certification 

under the Mandatory Guidelines. 

If any laboratory or IITF has 

withdrawn from the HHS National 

Laboratory Certification Program (NLCP) 

during the past month, it will be listed 

at the end and will be omitted from the 

monthly listing thereafter. 

This notice is also available on the 

internet at https://www.samhsa.gov/ 

workplace/resources/drug-testing/ 

certified-lab-list. 

The Department of Health and Human 

Services (HHS) notifies federal agencies 

of the laboratories and Instrumented 

Initial Testing Facilities (IITFs) 

currently certified to meet the standards 

of the Mandatory Guidelines for Federal 

Workplace Drug Testing Programs 

(Mandatory Guidelines) using Urine and 

of the laboratories currently certified to 

meet the standards of the Mandatory 

Guidelines using Oral Fluid. 

The Mandatory Guidelines using 

Urine were first published in the 

Federal Register on April 11, 1988 (53 

FR 11970), and subsequently revised in 

the Federal Register on June 9, 1994 (59 

FR 29908); September 30, 1997 (62 FR 

51118); April 13, 2004 (69 FR 19644); 

November 25, 2008 (73 FR 71858); 

December 10, 2008 (73 FR 75122); April 

30, 2010 (75 FR 22809); and on January 

23, 2017 (82 FR 7920). 

The Mandatory Guidelines using Oral 

Fluid were first published in the 

Federal Register on October 25, 2019 

(84 FR 57554) with an effective date of 

January 1, 2020. 

The Mandatory Guidelines were 

initially developed in accordance with 

Executive Order 12564 and section 503 

of Public Law 100–71 and allowed urine 

drug testing only. The Mandatory 

Guidelines using Urine have since been 

revised, and new Mandatory Guidelines 

allowing for oral fluid drug testing have 

been published. The Mandatory 

Guidelines require strict standards that 

laboratories and IITFs must meet in 

order to conduct drug and specimen 

validity tests on specimens for federal 

agencies. HHS does not allow IITFs to 

conduct oral fluid testing. 

To become certified, an applicant 

laboratory or IITF must undergo three 

rounds of performance testing plus an 

on-site inspection. To maintain that 

certification, a laboratory or IITF must 

participate in a quarterly performance 

testing program plus undergo periodic, 

on-site inspections. 

Laboratories and IITFs in the 

applicant stage of certification are not to 

be considered as meeting the minimum 

requirements described in the HHS 

Mandatory Guidelines using Urine and/ 

or Oral Fluid. An HHS-certified 

laboratory or IITF must have its letter of 

certification from HHS/SAMHSA 

(formerly: HHS/NIDA), which attests 

that the test facility has met minimum 

standards. HHS does not allow IITFs to 

conduct oral fluid testing. 

HHS-Certified Laboratories Approved 

To Conduct Oral Fluid Drug Testing 

In accordance with the Mandatory 

Guidelines using Oral Fluid dated 

October 25, 2019 (84 FR 57554), the 

following HHS-certified laboratories 

meet the minimum standards to conduct 

drug and specimen validity tests on oral 

fluid specimens: 

At this time, there are no laboratories 

certified to conduct drug and specimen 

validity tests on oral fluid specimens.