13394 Federal Register / Vol. 86, No. 43 / Monday, March 8, 2021 / Notices 

work is cryptosporidiosis, an acute 

diarrheal disease caused by infection 

with Cryptosporidium parasites. 

The Case Surveillance node is a subunit within the Domestic WASH 

Epidemiology Team which focuses on 

the data collection and management 

activities of six waterborne diseases, 

including cryptosporidiosis, in the 

United States. The Case Surveillance 

node’s current scope of work includes 

modernizing data collection and 

management, enabling data connections, 

and improving public data access to aid 

public health action. 

CryptoNet is the first molecular 

tracking system for Cryptosporidium in 

the United States. To meet the needs of 

the CryptoNet, the Case Surveillance 

node, and the needs of local officials, 

the CryptoNet case report form (CRF) 

was developed. The CRF includes a set 

of data elements that can be used to 

identify exposure trends in outbreakand non-outbreak-associated 

Cryptosporidium cases, to generate 

hypotheses about the source(s) of 

infection in clusters or outbreaks, and to 

identify strategies to prevent and control 

Cryptosporidium cases, clusters, or 

outbreaks. 

Data from the CRF will be used by 

federal, state, and local public health 

officials responsible for conducting 

interviews with reported cases of 

cryptosporidiosis in their jurisdiction in 

order to systematically assess core 

exposure elements and risk factors 

among cases of cryptosporidiosis. 

Collected data will be used by CDC staff 

to inform cryptosporidiosis sporadic 

case and cluster and outbreak 

prevention and control strategies. CRF 

data elements and the CRF form were 

designed for administration via 

telephone interviews with individuals 

ill with cryptosporidiosis, or their 

designated proxy. 

CDC requests OMB approval for an 

estimated 125 annual burden hours. 

Providing information is voluntary, and 

there are no costs to respondents other 

than their time. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondents Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total burden 

(in hours) 

Individuals ill with cryptosporidiosis, or their designated proxy.CryptoNet Case Report 

Form.

500 1 15/60 125 

Total ............................................................... ....................................... ........................ ........................ ........................ 125 

Jeffrey M. Zirger, 

Lead, Information Collection Review Office, 

Office of Scientific Integrity, Office of Science, 

Centers for Disease Control and Prevention. 

[FR Doc. 2021–04669 Filed 3–5–21; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[60Day–21–0307 Docket No. CDC–2021– 

0017] 

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 

proposed information collection project 

titled ‘‘Gonococcal Isolate Surveillance 

Project (GISP)’’. The purpose of GISP is 

to monitor trends in antimicrobial 

resistance in N. gonorrhoeae strains in 

the United States in order 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. 

DATES: CDC must receive written 

comments on or before May 7, 2021. 

ADDRESSES: You may submit comments, 

identified by Docket No. CDC–2021– 

0017 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; 


jbell on DSKJLSW7X2PROD with NOTICES
Federal Register / Vol. 86, No. 43 / Monday, March 8, 2021 / Notices 13395 

3. Enhance the quality, utility, and 

clarity of the information to be 

collected; and 

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. 

5. Assess information collection costs. 

Proposed Project 

Gonococcal Isolate Surveillance 

Project (OMB Control No. 0920–0307, 

Exp. 8/31/2021)—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) 

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. 


jbell on DSKJLSW7X2PROD with NOTICES
13396 Federal Register / Vol. 86, No. 43 / Monday, March 8, 2021 / Notices 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondent Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total burden 

hours 

Sentinel site conducting culturebased core surveillance.Demographic/Clinical Data (Attachment 3a1).20 240 11/60 880 

Sentinel site conducting culturebased enhanced surveillance.Demographic/Clinical Data (Attachment 3a2).10 840 12/60 1,680 

Sentinel site conducting molecular 

enhanced surveillance.

Demographic/Clinical Data (Attachment 3a2).10 840 12/60 1,680 

Regional laboratory ........................... Antimicrobial Susceptibility Testing 

Results (Attachment 3b).

4 3,300 40/60 8,800 

Control Strain Susceptibility Testing ........................ 48 5/60 16 

Total ........................................... ........................................................... 44 ........................ ........................ 13,056 

Jeffrey M. Zirger, 

Lead, Information Collection Review Office, 

Office of Scientific Integrity, Office of Science, 

Centers for Disease Control and Prevention. 

[FR Doc. 2021–04671 Filed 3–5–21; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Submission for OMB Review; Family 

Violence Prevention and Services 

Program (OMB #0970–0280) 

AGENCY: Family and Youth Services 

Bureau; Administration on Children, 

Youth and Families; Administration for 

Children and Families (ACF); HHS. 

ACTION: Request for public comment. 

SUMMARY: The Administration on 

Children, Youth and Families, Family 

and Youth Services Bureau plans to 

extend data collection for the Family 

Violence Prevention and Services 

Program (OMB #0970–0280; Expiration 

Date: March 31, 2021). No changes are 

proposed to the existing information 

collection. 

DATES: Comments due within 30 days of 

publication. OMB must make a decision 

about the collection of information 

between 30 and 60 days after 

publication of this document in the 

Federal Register. Therefore, a comment 

is best assured of having its full effect 

if OMB receives it within 30 days of 

publication. 

ADDRESSES: Written 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. 

SUPPLEMENTARY INFORMATION: 

Description: The Family Violence 

Prevention and Services Act (FVPSA) 

Program has a legislative requirement 

for grantees to report on activities 

carried out throughout their grant 

period and provide an evaluation on the 

effectiveness of the activities in 

achieving the purposes of the grant. 

Grantees must collect unduplicated data 

and only share non-personally 

identifying information, in the 

aggregate, regarding services to their 

clients in order to comply with federal, 

state, or tribal reporting, evaluation, or 

data collection requirements, 42 U.S.C. 

10406(c)(5)(D). Client-level data shall 

not be shared with a third party, 

regardless of encryption, hashing, or 

other data security measures, without a 

written, time-limited release as 

described in 42 U.S.C. 10406(c)(5). 

Respondents: FVPSA-funded 

grantees. 

ANNUAL BURDEN ESTIMATES

Instrument Number of 

respondents 

Total number 

of responses 

per respondent 

Average 

burden hours 

per response 

Total burden 

hours 

Annual burden 

hours 

FVPSA State Grants Funding Opportunity Announcement 52 1 10 520 173 

FVPSA Tribes/Tribal Organizations Grants Funding Opportunity Announcement ................................................ 150 1 10 1,500 500 

FVPSA State Domestic Violence Coalitions Grants Funding Opportunity Announcement ...................................... 56 1 10 560 187 

State FVPSA Grant Performance Progress Report .......... 52 3 10 1,560 520 

Tribal FVPSA Grant Performance Progress Report .......... 150 3 10 4,500 1,500 

State Domestic Violence Coalition Performance Progress 

Report ............................................................................. 56 3 10 1,680 560 


jbell on DSKJLSW7X2PROD with NOTICES