35292 Federal Register / Vol. 86, No. 125 / Friday, July 2, 2021 / Notices 

facilities covered by the EEOICPA 

programs; or familiarity, experience, or 

history of participation with the 

EEOICPA program. Any interested 

person or organization may nominate 

one or more individuals for 

membership. Interested persons are also 

invited and encouraged to submit 

statements in support of nominees. 

The ABRWH consists of not more 

than 20 members appointed by the 

President of the United States. As 

required by 42 U.S.C. 7384o(a)(2), the 

President makes appointments to the 

ABRWH in consultation with 

organizations with expertise on worker 

health issues in order to ensure that the 

membership of the ABRWH reflects a 

balance of scientific, medical, and 

worker perspectives. As required by 42 

U.S.C. 7384o(a)(3), the President 

designates a Chair for the ABRWH from 

among its members. The authorizing 

statutory provision under 42 U.S.C. 

7384o and Section 4 of Executive Order 

13179 do not include a limit for terms 

of appointment for ABRWH members. 

Nomination Process: Any interested 

person or organization may nominate 

one or more qualified individuals for 

membership. If you would like to 

nominate an individual or yourself for 

appointment to the ABRWH, please 

submit the following information: 

• The nominee’s contact information 

(name, title, business address, business 

phone, fax number, and/or business 

email address) and current employment 

or position. 

• A copy of the nominee’s resume or 

curriculum vitae; category of 

membership (e.g., scientific, medical, 

and/or worker perspective) that the 

nominee represents; a summary of the 

background, experience, and 

qualifications that addresses the 

nominee’s suitability for the nominated 

membership category identified above. 

• Articles or other documents the 

nominee has authored that indicate the 

nominee’s knowledge, experience, and 

expertise in the fields of health physics, 

industrial hygiene, toxicology, 

epidemiology, occupational medicine, 

or the worker perspective in the nuclear 

facilities covered by the EEOICPA 

program; or familiarity, experience, or 

history of participation with the 

EEOICPA program. Nominations may be 

submitted by the candidate him or 

herself, or by the person/organization 

recommending the candidate. 

• At least one letter of 

recommendation from person(s) not 

employed by the U.S. Department of 

Health and Human Services. Candidates 

may submit letter(s) from current HHS 

employees if they wish, but at least one 

letter must be submitted by a person not 

employed by an HHS agency (e.g., CDC, 

NIH, FDA, etc.). 

The Director, Strategic Business 

Initiatives Unit, Office of the Chief 

Operating Officer, Centers for Disease 

Control and Prevention, has been 

delegated the authority to sign Federal 

Register notices pertaining to 

announcements of meetings and other 

committee management activities, for 

both the Centers for Disease Control and 

Prevention and the Agency for Toxic 

Substances and Disease Registry. 

Kalwant Smagh, 

Director, Strategic Business Initiatives Unit, 

Office of the Chief Operating Officer, Centers 

for Disease Control and Prevention. 

[FR Doc. 2021–14204 Filed 7–1–21; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[30Day–21–0307] 

Agency Forms Undergoing Paperwork 

Reduction Act Review 

In accordance with the Paperwork 

Reduction Act of 1995, the Centers for 

Disease Control and Prevention (CDC) 

has submitted the information 

collection request titled ‘‘Gonococcal 

Isolate Surveillance Project (GISP)’’ to 

the Office of Management and Budget 

(OMB) for review and approval. CDC 

previously published a ‘‘Proposed Data 

Collection Submitted for Public 

Comment and Recommendations’’ 

notice on March 8, 2021 to obtain 

comments from the public and affected 

agencies. CDC did not receive comments 

related to the previous notice. This 

notice serves to allow an additional 30 

days for public and affected agency 

comments. 

CDC will accept all comments for this 

proposed information collection project. 

The Office of Management and Budget 

is particularly interested in comments 

that: 

(a) Evaluate whether the proposed 

collection of information is necessary 

for the proper performance of the 

functions of the agency, including 

whether the information will have 

practical utility; 

(b) Evaluate the accuracy of the 

agencies estimate of the burden of the 

proposed collection of information, 

including the validity of the 

methodology and assumptions used; 

(c) Enhance the quality, utility, and 

clarity of the information to be 

collected; 

(d) Minimize the burden of the 

collection of information on those who 

are to respond, including, through the 

use of appropriate automated, 

electronic, mechanical, or other 

technological collection techniques or 

other forms of information technology, 

e.g., permitting electronic submission of 

responses; and 

(e) Assess information collection 

costs. 

To request additional information on 

the proposed project or to obtain a copy 

of the information collection plan and 

instruments, call (404) 639–7570. 

Comments and recommendations for the 

proposed information collection should 

be sent within 30 days of publication of 

this notice to www.reginfo.gov/public/ 

do/PRAMain. Find this particular 

information collection by selecting 

‘‘Currently under 30-day Review—Open 

for Public Comments’’ or by using the 

search function. Direct written 

comments and/or suggestions regarding 

the items contained in this notice to the 

Attention: CDC Desk Officer, Office of 

Management and Budget, 725 17th 

Street NW, Washington, DC 20503 or by 

fax to (202) 395–5806. Provide written 

comments within 30 days of notice 

publication. 

Proposed Project 

Gonococcal Isolate Surveillance 

Project—Revision—National Center for 

HIV/AIDS, Viral Hepatitis, STD, TB 

Prevention (NCHHSTP), Centers for 

Disease Control and Prevention (CDC). 

Background and Brief Description 

The Gonococcal Isolate Surveillance 

Project (GISP) was created in 1986 to 

monitor trends in antimicrobial 

susceptibilities of Neisseria gonorrhoeae 

strains in the United States. GISP 

continues to be a collaboration between 

different branches of the CDC’s Division 

of STD Prevention, selected regional 

laboratories, and selected state/local 

public health departments and their 

associated STD specialty care clinics in 

the United States. National 

organizations, local jurisdictions and 

individuals use data collected in GISP 

to understand, monitor, and prevent 

further transmission of antibiotic 

resistant strains of N. gonorrhoeae. Data 

from GISP are used to establish a 

scientific basis for the selection of 

gonococcal therapies and to allow proactive changes to treatment guidelines 

before widespread resistance and 

failures of treatment occur. To increase 

capacity to detect and monitor resistant 

gonorrhea and to improve the specificity 

of GISP, this revision is being submitted 

to include collection of remnant nucleic 

acid amplification test (NAAT) 


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Federal Register / Vol. 86, No. 125 / Friday, July 2, 2021 / Notices 35293 

specimens and updated data element 

options for treatment received based on 

the 2020 updated gonorrhea treatment 

recommendations. 

GISP core surveillance activities 

sample <4% of reported male gonorrhea 

cases in the United States and are 

limited to urethral infections only. In 

2018, enhanced GISP (eGISP) began 

sampling female genital (endocervical 

and vaginal) and male and female 

extragenital (pharyngeal and rectal) 

anatomic sites, in addition to the male 

genital site already sampled in GISP 

core surveillance. Including isolates 

from the pharynx and other anatomic 

sites, as well as from women, expands 

on GISP’s public health efforts to detect 

and respond to resistance more quickly. 

GISP surveillance was also strengthened 

with the addition of eGISP by 

identifying isolates that are culture 

positive for N. gonorrhoeae, but 

negative by NAAT, which is a more 

specific diagnostic test. This helped to 

ensure that non-gonococcal bacteria are 

excluded from gonococcal data, 

strengthening the accuracy and 

usefulness of GISP data, especially 

when clinical syndromes with other 

Neisseria species are indistinguishable 

from gonorrhea. 

To further improve and strengthen 

GISP surveillance, an additional 

enhanced surveillance activity in the 

form of molecular surveillance has been 

added to this revision. Participating 

sites already locally performing NAATs 

would retain the leftover gonorrheapositive samples (remnant) after 

diagnostic results have been determined 

and reported as part of standard care. 

The gonorrhea-positive remnant NAAT 

sample would be frozen, stored, and 

then shipped directly to CDC on a 

monthly basis for molecular 

characterization of known resistanceconferring gene mutations. Remnant 

NAAT specimens from any anatomic 

site (including from the urethra, 

pharynx, rectum, vagina, and cervix) of 

gonorrhea positive persons will be 

accepted. We anticipate that 10 sites 

will participate in this molecular 

surveillance activity and we anticipate 

up to 70 positive remnant NAAT 

specimens per month will be sent by 

each of these 10 sites to CDC for testing. 

To maintain accurate collection of 

GISP data elements, this revision also 

includes the updated weight-based 

dosing of ceftriaxone and cefixime. In 

December 2020, CDC released the 

‘‘Update to CDC’s Treatment Guidelines 

for Gonococcal Infection.’’ These new 

treatment recommendations increased 

the dose of the recommended regimen 

and the dose for an alternative regimen 

(ceftriaxone and cefixime, respectively). 

These values, collected and recorded 

under the received treatment data 

element, are being added to allow for 

the collection of treatment data 

consistent with these updated 

recommendations. 

Under this revision, the data 

collection and processes for all GISP 

activities are unchanged. The increased 

dosages for ceftriaxone and cefixime 

treatments allow for new data element 

options, but not a change in the number 

of data elements or the current work 

demand to collect them. All 

demographic/clinical data from the 

sentinel sites will be submitted 

electronically directly from the sentinel 

sites to the GISP data manager at CDC 

through; (1) a secure data portal, or (2) 

through the CDC Secure Access 

Management Services partner portal. To 

minimize burden, comma-separated 

values (csv) files that provide 

standardized structure of the electronic 

data are provided to sentinel sites and 

laboratories. Additionally, to further 

minimize burden, the regional 

laboratories will be able to extract 

electronic data directly from electronic 

laboratory information systems instead 

of hand entering data. Laboratories are 

not required to report control strain 

testing results. 

This project will not collect name, 

social security number, or date of birth. 

A Patient ID, a unique patient identifier 

assigned by the site that allows for 

linking of multiple isolates from a single 

person at a single clinic visit and across 

multiple clinic visits, is requested and 

will be provided to CDC for purposes of 

enhanced surveillance. Sensitive 

information such as sex of sex partners, 

HIV status, sex work exposure, and 

injection drug use are collected. Patient 

data are obtained through review of 

medical records by the clinic staff and 

included in collection reporting of 

demographic/clinical information. All 

personally identifiable information (PII) 

is retained by the STD clinics that 

treated the patient and is not recorded 

with data sent to CDC or regional 

laboratories. The electronic GISP 

database is stored on the CDC 

mainframe computer and only approved 

Division of STD Prevention (DSTDP) 

staff have access rights to the data. As 

part of the revision, we will continue to 

systematically identify the risks and 

potential effects of collecting, 

maintaining, and disseminating PII and 

to examine and evaluate alternative 

processes for handling that information 

to mitigate potential privacy risks and 

risks to confidentiality. 

The CDC has designated N. 

gonorrhoeae as one of five ‘‘urgent’’ 

antibiotic resistance threats in the 

United States. The CDC is requesting a 

three-year OMB approval for this 

revision, which directly responds to the 

National Strategy for Combating 

Antibiotic Resistant Bacteria by 

improving and strengthening 

surveillance of antimicrobial resistance 

through GISP. GISP data can help 

monitor and evaluate the effectiveness 

of public health interventions 

conducted to support the National 

Strategy for Combating Antibiotic 

Resistant Bacteria. There are no costs to 

respondents other than their time. The 

estimated annual burden is 13,056 

hours. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondent Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Sentinel site conducting culture-based core 

surveillance.

Demographic/Clinical Data ............................. 20 240 11/60 

Sentinel site conducting culture-based enhanced surveillance.Demographic/Clinical Data ............................. 10 840 12/60 

Sentinel site conducting molecular enhanced 

surveillance.

Demographic/Clinical Data ............................. 10 840 12/60 

Regional laboratory ......................................... Antimicrobial Susceptibility Testing Results .. 4 3,300 40/60 

Control Strain Susceptibility Testing .............. 48 5/60 


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35294 Federal Register / Vol. 86, No. 125 / Friday, July 2, 2021 / Notices 

Jeffrey M. Zirger, 

Lead, Information Collection Review Office, 

Office of Scientific Integrity, Office of Science, 

Centers for Disease Control and Prevention. 

[FR Doc. 2021–14226 Filed 7–1–21; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[60Day–21–21GA Docket No. CDC–2021– 

0061] 

Proposed Data Collection Submitted 

for Public Comment and 

Recommendations 

AGENCY: Centers for Disease Control and 

Prevention (CDC), Department of Health 

and Human Services (HHS). 

ACTION: Notice with comment period. 

SUMMARY: The Centers for Disease 

Control and Prevention (CDC), as part of 

its continuing effort to reduce public 

burden and maximize the utility of 

government information, invites the 

general public and other Federal 

agencies the opportunity to comment on 

a proposed and/or continuing 

information collection, as required by 

the Paperwork Reduction Act of 1995. 

This notice invites comment on a 

proposal to allow CDC’s National Center 

for HIV/AIDS, Viral Hepatitis, STD, and 

TB Prevention (NCHHSTP), Division of 

Adolescent and School Health (DASH) 

to conduct a research information 

collection project titled ‘‘Teen and 

Parents Surveys of Health (TAPS)’’. This 

project serves to inform the CDC’s 

Division of Adolescent and School 

Health’s (DASH) key school-based 

programmatic strategies of improving 

family- and school-level protective 

factors, bolstering health education, and 

increasing adolescent access to quality 

health services. 

DATES: CDC must receive written 

comments on or before August 31, 2021. 

ADDRESSES: You may submit comments, 

identified by Docket No. CDC–2021– 

0061 by any of the following methods: 

• Federal eRulemaking Portal: 

Regulations.gov. Follow the instructions 

for submitting comments. 

• Mail: Jeffrey M. Zirger, Information 

Collection Review Office, Centers for 

Disease Control and Prevention, 1600 

Clifton Road NE, MS–D74, Atlanta, 

Georgia 30329. 

Instructions: All submissions received 

must include the agency name and 

Docket Number. CDC will post, without 

change, all relevant comments to 

Regulations.gov. 

Please note: Submit all comments 

through the Federal eRulemaking portal 

(regulations.gov) or by U.S. mail to the 

address listed above. 

FOR FURTHER INFORMATION CONTACT: To 

request more information on the 

proposed project or to obtain a copy of 

the information collection plan and 

instruments, contact Jeffrey M. Zirger, 

Information Collection Review Office, 

Centers for Disease Control and 

Prevention, 1600 Clifton Road NE, MS– 

D74, Atlanta, Georgia 30329; phone: 

404–639–7118; Email: omb@cdc.gov. 

SUPPLEMENTARY INFORMATION: Under the 

Paperwork Reduction Act of 1995 (PRA) 

(44 U.S.C. 3501–3520), Federal agencies 

must obtain approval from the Office of 

Management and Budget (OMB) for each 

collection of information they conduct 

or sponsor. In addition, the PRA also 

requires Federal agencies to provide a 

60-day notice in the Federal Register 

concerning each proposed collection of 

information, including each new 

proposed collection, each proposed 

extension of existing collection of 

information, and each reinstatement of 

previously approved information 

collection before submitting the 

collection to the OMB for approval. To 

comply with this requirement, we are 

publishing this notice of a proposed 

data collection as described below. 

The OMB is particularly interested in 

comments that will help: 

1. Evaluate whether the proposed 

collection of information is necessary 

for the proper performance of the 

functions of the agency, including 

whether the information will have 

practical utility; 

2. Evaluate the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information, 

including the validity of the 

methodology and assumptions used; 

3. Enhance the quality, utility, and 

clarity of the information to be 

collected; 

4. Minimize the burden of the 

collection of information on those who 

are to respond, including through the 

use of appropriate automated, 

electronic, mechanical, or other 

technological collection techniques or 

other forms of information technology, 

e.g., permitting electronic submissions 

of responses; and 

5. Assess information collection costs. 

Proposed Project 

Teen and Parents Surveys of Health 

(TAPS)—New—National Center for 

HIV/AIDS, Viral Hepatitis, STD, and TB 

Prevention (NCHHSTP), Centers for 

Disease Control and Prevention (CDC). 

Background and Brief Description 

The Centers for Disease Control and 

Prevention (CDC), National Center for 

HIV/AIDS, Viral Hepatitis, STD, and TB 

Prevention (NCHHSTP), Division of 

Adolescent and School Health (DASH) 

requests approval for ‘‘Teen and Parent 

Surveys of Health (TAPS)’’ through an 

existing online panel using NORC at the 

University of Chicago’s AmeriSpeaks 

panel. Documenting health-related risk 

behaviors and experiences and health 

outcomes of young people through 

routine surveillance is a critical 

component of DASH’s prevention 

efforts. Another component of DASH’s 

efforts to improve adolescent health is 

observational research to inform its 

school-based programmatic strategies. 

This type of research serves to inform 

priority settings and sub-populations for 

intervention as well as specific 

intervention strategies. TAPS data will 

allow DASH to refine existing strategies 

for funded school district partners to 

improve the quality of their programs 

and services to prevent HIV, other STDs, 

and pregnancy among adolescents, as 

well as improve mental health, sexual 

health and other adolescent health 

outcomes (e.g., substance use, violence 

victimization). Data will be used to 

inform DASH’s key school-based 

programmatic strategies of improving 

family- and school-level protective 

factors, bolstering health education, and 

increasing adolescent access to quality 

health services. This observational 

research complements and extends 

DASH’s ongoing surveillance efforts 

through the Youth Risk Behavioral 

Surveillances System (YRBSS) (OMB 

Control No. 0920–0493, Exp. 11/30/ 

2023), which provides key national 

estimates of adolescent health risk 

behaviors and health outcomes, by 

providing a deeper dive into individual, 

family, and school factors that 

positively associate with adolescent 

behaviors and health outcomes. 

Collecting this observational data 

provides the opportunity to examine 

untested associations of protective 

factors, health education experiences, 

and health service use (immediate 

outcomes of DASH strategies) with 

mental health, sexual health, and 

substance use outcomes. 

CDC requests approval for an 

estimated 1,378 annual burden hours. 

There are no costs to respondents other 

than their time to participate. 


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