Federal Register / Vol. 87, No. 127 / Tuesday, July 5, 2022 / Notices 39837 

SUMMARY: The Centers for Disease 

Control and Prevention (CDC), located 

within the Department of Health and 

Human Services (HHS), is interested in 

obtaining information on available 

platforms for nucleic acid amplification 

or detection that meet criteria outlined 

below in the SUPPLEMENTARY

INFORMATION section below. 

DATES: Manufacturers are asked to 

contact CDC at the address below by 

August 19, 2022. 

FOR FURTHER INFORMATION CONTACT: 

Laura Hughes-Baker, Centers for Disease 

Control and Prevention, 1600 Clifton 

Road NE, MS H24–12, Atlanta, GA 

30329–4027. Telephone: (404) 639– 

1402; Email: eocevent521@cdc.gov. 

SUPPLEMENTARY INFORMATION:

Background: Nucleic acid 

amplification or detection is used in 

many diagnostic tests. Rapid and 

accurate results that can specifically 

detect small amounts of pathogen 

material are essential to identifying and 

tracking diseases. The recent pandemic 

has demonstrated the need for tests that 

can be used in public health laboratories 

across the United States and 

internationally. 

Many CDC laboratories across the 

agency use a particular diagnostic 

platform for nucleic acid detection. 

Because this current platform will be 

retired in the future, CDC is interested 

in hearing from manufacturers regarding 

the availability of current and potential 

platforms that could support CDC’s 

overall diagnostics and surveillance. 

Criteria: Ideally, the replacement 

platform should: 

• Be suitable for research, 

surveillance, or assay development, and 

in vitro diagnostic purposes; 

• Have Food and Drug 

Administration (FDA) clearance for 

diagnostic use or a research platform 

capable of obtaining FDA clearance; 

• Be compatible with a 96 well 

format; 

• Be compatible with diagnostic, 

surveillance, or characterization tests 

targeting a variety of pathogens; and 

• Have software that allows for 

flexibility in analysis. 

Manufactures who may have a 

platform that meets these criteria should 

submit information to CDC at 

eocevent521@cdc.gov or the address 

provided in the FOR FURTHER

INFORMATION section above. 

All information submitted to CDC will 

be kept confidential as allowed by 

relevant federal law, including the 

Freedom of Information Act (5 U.S.C. 

552) and the Trade Secrets Act (18 

U.S.C. 1905). 

Disclaimer and Important Notes 

This notice is for planning purposes; 

it does not constitute a formal 

announcement for comprehensive 

applications. In accordance with 

Federal Acquisition Regulation 48 CFR 

15.201(e), responses to this notice are 

not offers and cannot be accepted by the 

Government to form a binding award. 

CDC will not provide reimbursement for 

costs incurred in responding to this 

notice. 

Dated: June 29, 2022. 

Angela K. Oliver, 

Executive Secretary, Centers for Disease 

Control and Prevention. 

[FR Doc. 2022–14211 Filed 7–1–22; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[60Day–22–1273; Docket No. CDC–2022– 

0080] 

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 continuing information collection, as 

required by the Paperwork Reduction 

Act of 1995. This notice invites 

comment on a proposed information 

collection project titled Pregnancy Risk 

Assessment Monitoring System 

(PRAMS). PRAMS is a surveillance 

project of the Centers for Disease 

Control and Prevention (CDC) and state 

health departments that collects 

jurisdiction-specific, population-based 

data on maternal attitudes and 

experiences before, during, and shortly 

after pregnancy. 

DATES: CDC must receive written 

comments on or before September 6, 

2022. 

ADDRESSES: You may submit comments, 

identified by Docket No. CDC–2022– 

0080 by either of the following methods: 

• Federal eRulemaking Portal: 

www.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 H21–8, Atlanta, 

Georgia 30329. 

Instructions: All submissions received 

must include the agency name and 

Docket Number. CDC will post, without 

change, all relevant comments to 

www.regulations.gov. 

Please note: Submit all comments 

through the Federal eRulemaking portal 

(www.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 

H21–8, Atlanta, Georgia 30329; 

Telephone: 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, 


lotter on DSK11XQN23PROD with NOTICES1
39838 Federal Register / Vol. 87, No. 127 / Tuesday, July 5, 2022 / Notices 

e.g., permitting electronic submissions 

of responses; and 

5. Assess information collection costs. 

Proposed Project 

Pregnancy Risk Assessment 

Monitoring System (PRAMS) (OMB 

Control No. 0920–1273, Exp. 11/30/ 

2022)—Revision—National Center for 

Chronic Disease Prevention and Health 

Promotion (NCCDPHP), Centers for 

Disease Control and Prevention (CDC). 

Background and Brief Description 

The Pregnancy Risk Assessment 

Monitoring System (PRAMS) is a 

surveillance project of the Centers for 

Disease Control and Prevention (CDC) 

and state health departments. 

Developed in 1987, PRAMS collects 

jurisdiction-specific, population-based 

data on maternal attitudes and 

experiences before, during, and shortly 

after pregnancy. 

PRAMS provides data not available 

from other sources. These data can be 

used to identify groups of women and 

infants at high risk for health problems, 

to monitor changes in health status, and 

to measure progress towards goals in 

improving the health of mothers and 

infants. PRAMS data are used by 

researchers to investigate emerging 

issues in the field of reproductive health 

and by federal, state and local 

governments to plan and review 

programs and policies aimed at 

reducing health problems among 

mothers and babies. 

PRAMS is a jurisdiction customized 

survey conducted in 50 sites and covers 

81% of all live births in the United 

States. Information is collected 2–6 

months after live birth or stillbirth by 

mail survey with telephone follow-up 

for non-responders. In 2022, five 

jurisdictions piloted a web mode for 

data collection, with plans to scale up 

to all jurisdictions in 2023. Because 

PRAMS uses standardized data 

collection methods, it allows data to be 

compared among sites. Jurisdictions can 

implement the survey on an ongoing 

basis or as a point-in-time survey. In 

participating jurisdictions, a sample of 

women who have recently given birth to 

a live born or stillborn infant is selected 

from birth certificates or fetal death 

files. The sample is stratified based on 

the site’s population of interest to 

ensure high-risk populations are 

adequately represented in the data. 

The PRAMS survey instrument for 

live births is based on a core set of 

questions common across all 

jurisdictions that remain the same 

throughout each phase of data 

collection. In addition, CDC provides 

optional standardized modules (pregrouped questions on a select topic) that 

jurisdiction may use to customize 

survey content at the beginning of each 

phase of data collection. Topics for both 

the core and standard modules include 

demographic and background, health 

conditions (which includes chronic 

conditions such as diabetes, 

hypertension, mental health, oral 

health, cancer, as well as pregnancyinduced health conditions and family 

history of select conditions); health 

behaviors (including tobacco and 

alcohol use, substance use [licit and 

illicit], injury prevention and safety, 

nutrition, and physical activity); health 

care services (such as preconception 

care, prenatal care, postpartum care, 

contraceptive care, vaccinations, access 

to care and insurance coverage, receipt 

of recommended services and provider 

counseling received); infant health and 

development; infant care practices (such 

as breastfeeding, safe sleep practices); 

social services received (such as WIC or 

home visiting); the social context of 

childbearing (such as intimate partner 

violence, social support, adverse 

childhood experiences, stressful life 

experiences and racism); attitudes and 

feeling about the pregnancy including 

pregnancy intentions. 

CDC is seeking approval for a 

Revision of the PRAMS collection to 

include Phase 8, which will conclude 

March 2023, and to incorporate Phase 9, 

which will begin in April 2023. The 

Phase 9 survey will include the same 

question topics and most of the same 

questions for core and standard modules 

from Phase 8. The content on some 

topics will be expanded, for example, 

questions related to the social context of 

childbearing has been broadened with 

new questions such as those on 

experiences of racism and food, 

housing, and transportation insecurity. 

For Phase 9, some questions have been 

added and some Phase 8 questions have 

been modified (e.g., by reducing the 

number of response choices). 

Additionally, some questions from the 

Phase 8 core modules will not be 

included in the Phase 9 core modules. 

These questions are still available for 

jurisdictions to use as part of the 

standard modules. 

Because PRAMS infrastructure was 

developed to access a specific 

population, the PRAMS infrastructure is 

uniquely suited for rapid adaption for 

information collection that would not be 

feasible with other surveillance 

methods. At times, states may also be 

funded to address emerging topics of 

interest with supplemental modules 

(pre-grouped questions on a select 

topic). These supplemental modules 

address national and site-specific 

priorities. Supplemental modules, for 

which continued collection for Phase 8 

of PRAMS births is planned include 

disabilities, marijuana use, prescription 

and illicit opioid use, COVID–19 

experience, COVID–19 vaccine, and 

social determinants of health. New 

supplemental modules may be 

developed to address other emergent 

issues as they arise. 

PRAMS can also be adapted to do call 

back surveys. Women who respond to 

the PRAMS survey may be re-contacted 

(opt-out consent process used) at a later 

date (most recent opioid call back 

survey occurred approximately nine 

months post-birth) to collect additional 

information about post-pregnancy 

experiences and infant and toddler 

health. No call back survey is currently 

being fielded or planned but call back 

surveys may be developed to address 

other emergent issues as they arise. 

The stillbirth survey is currently 

administered in the state of Utah only. 

It includes a single survey instrument. 

As part of the questionnaire 

development process, cognitive and 

field testing will be conducted prior to 

implementation of new supplemental 

modules and call back surveys. For 

subsequent phases of PRAMS 

questionnaires, new or substantively 

revised questions for the core or 

standard questions will be conducted 

prior to a new phase. Cognitive and 

field testing will be conducted among 

women with infants one year or 

younger. Cognitive testing is conducted 

to evaluate interpretive and cognitive 

processes used by respondents when 

responding to survey questions to 

identify difficulties experienced by 

respondents when answering the 

questions and as well as identify 

potential response errors. Field testing 

is conducted to identify issues that may 

affect implementation or quality of the 

data collected. 

OMB approval is requested for three 

years. The total estimated annual 

burden is 30,992 hours which is an 

increase of 1,227 hours. The change in 

overall burden results from: (1) a 

slightly reduced estimate of the number 

of responses to the PRAMS survey (core 

questions plus jurisdiction selected 

standard module) based on responses 

received in 2019 (decrease of 223 

hours), (2) an increase in the anticipated 

number of supplemental modules and 

the time to complete each module from 

five to eight minutes (increase of 1,836 

hours) based on current supplemental 

modules being implemented by 

jurisdictions, (3) a decrease in the 

estimated annual burden for call back 

surveys (decrease of 586 hours) with 

current estimates based on responses to 


lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 87, No. 127 / Tuesday, July 5, 2022 / Notices 39839 

the most recent call back survey, (4) the 

addition of cognitive testing to aid in 

the development of new or modification 

of existing questions (increase of 150 

hours), and (5) an increase in the 

amount of time allotted for each field 

testing interview resulting in an overall 

increase for field testing from 20 to 40 

minutes (increase of 50 hours). 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 

hours 

Women who recently delivered a live 

birth.

PRAMS Phase 8/Phase 9 (Core 

Questions plus state selected 

standard modules).

51,556 1 26/60 22,341 

Supplemental Modules ..................... 52,040 1 8/60 6,939 

Call Back Surveys ............................ 2,790 1 30/60 1,395 

Cognitive Testing ............................. 150 1 60/60 150 

Field Testing ..................................... 150 1 40/60 100 

Women who recently delivered a 

stillbirth.

PRAMS Stillbirth Questionnaire ....... 160 1 25/60 67 

Total ........................................... ........................................................... ........................ ........................ ........................ 30,992 

Jeffrey M. Zirger, 

Lead, Information Collection Review Office, 

Office of Scientific Integrity, Office of Science, 

Centers for Disease Control and Prevention. 

[FR Doc. 2022–14218 Filed 7–1–22; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[60Day-FY–2022; Docket No. CDC–2022– 

0082] 

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 Requirement for Proof of COVID– 

19 Vaccination for Noncitizen, 

Nonimmigrant Air Passengers Arriving 

into the United States from a Foreign 

Country. A Revision for this collection 

is being submitted to ensure that, 

consistent with the terms of the April 4, 

2022 Amended Order Under the 

Presidential Proclamation titled 

Advancing Safe Resumption of Global 

Travel During the COVID–19 Pandemic 

and CDC’s Order Implementing 

Proclamation on Advancing Safe 

Resumption of Global Travel During the 

COVID–19 Pandemic, public health 

authorities can confirm that non-U.S 

Citizen, Non-U.S. Immigrant passengers 

are fully vaccinated against COVID–19 

before boarding a plane to the United 

States. 

DATES: CDC must receive written 

comments on or before September 6, 

2022. 

ADDRESSES: You may submit comments, 

identified by Docket No. CDC–2022– 

0082 by either of the following methods: 

• Federal eRulemaking Portal: 

www.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 H21–8, Atlanta, 

Georgia 30329. 

Instructions: All submissions received 

must include the agency name and 

Docket Number. CDC will post, without 

change, all relevant comments to 

www.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 

H21–8, Atlanta, Georgia 30329; 

Telephone: 404–639–7570; 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. 


lotter on DSK11XQN23PROD with NOTICES1