[Federal Register Volume 86, Number 52 (Friday, March 19, 2021)]
[Notices]
[Pages 14921-14923]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-05762]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-21-1238; Docket No. CDC-2021-0029]


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.

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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, The EDN Tuberculosis Follow-Up 
Worksheet for Newly-Arrived Persons with Overseas Tuberculosis 
Classifications. This TB follow-up worksheet intends to capture 
domestic TB examination data for persons arriving to the U.S. with 
overseas TB classifications.

DATES: CDC must receive written comments on or before May 18, 2021.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2021-
0029 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.

[[Page 14922]]


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; Telephone: (404)639-7118. 
Email: [email protected].

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; 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

    Information Collection for The EDN Tuberculosis Follow-Up Worksheet 
for Newly-Arrived Persons with Overseas Tuberculosis Classifications 
(OMB Control No. 0920-1238, Exp. 6/30/2021)--Revision--National Center 
for Emerging and Zoonotic Infectious Diseases (NCEZID), Centers for 
Disease Control and Prevention (CDC).

Background and Brief Description

    CDC highly recommends that persons with overseas classification A 
or B for TB receive U.S. follow-up evaluations to prevent new 
transmission of TB. This information will assist CDC in fulfilling its 
regulatory responsibility to prevent the importation and spread of 
communicable diseases from foreign countries (42 CFR part 71) and 
interstate control of communicable diseases in humans (42 CFR part 70). 
Section 361 of the Public Health Service (PHS) Act (42 U.S.C. 264) 
authorizes the Secretary of Health and Human Services to make and 
enforce regulations necessary to prevent the introduction, 
transmission, or spread of communicable disease from foreign countries 
into the United States. Under its delegated authority in 42 CFR parts 
70 and 71, the Division of Global Migration and Quarantine (DGMQ) works 
to fulfill this responsibility through numerous activities that include 
monitoring the arrival of persons with Class A and Class B tuberculosis 
(TB) conditions and coordinating domestic follow-up examinations to 
prevent new transmission of TB in the United States.
    The Secretary of Health and Human Services also has the legal 
authority to establish regulations outlining the requirements for the 
medical examination of aliens before they may be admitted into the 
United States. This authority is provided under Section 212(a)(1)(A) of 
the Immigration and Nationality Act (8 U.S.C. 1182(a)(1)(A)) and 
Section 325 of the Public Health Service Act 42 U.S.C. 252. These 
regulations are codified in 42 CFR part 34, which establish 
requirements that determine whether aliens can be admitted into the 
United States, which includes health examinations when aliens attempt 
to adjust status to lawful permanent residents.
    The TB follow-up worksheet is designed to capture U.S. TB 
examination data for newly arriving persons to the U.S. with overseas 
classification A and B for TB. The information collected by the TB 
follow-up worksheet will provide a method of performing several TB 
prevention activities, both international and domestic in nature.
    The U.S. foreign-born population had the highest incidence of TB 
compared to the U.S. non-foreign-born population. CDC strongly 
recommends incoming persons receive follow-up examinations for TB in 
the U.S. This data collection will facilitate the methodical collection 
of TB follow-up outcome data to monitor and track persons with overseas 
classification A and B for TB and will assist in the national effort to 
prevent new transmission of TB. To accurately determine rates of TB, 
recent U.S. arrivals receive domestic follow-up evaluations. U.S. 
health departments will provide domestic follow-up outcome information 
to CDC. Without this data, DGMQ will not have a method of tracking and 
monitoring newly arrived persons with overseas classification A or B 
for TB. DGMQ will use information reported on the worksheet to ensure 
that TB programs are effectively tracking new foreign arrivals and 
coordinating follow-up evaluations with local clinicians. To monitor 
and evaluate domestic TB program performance, CDC needs to collect data 
on all elements of TB domestic follow-up evaluations including chest x-
rays, diagnoses, and U.S. treatment outcomes.
    The Division of Global Migration and Quarantine (DGMQ) staff along 
with other federal partners will also use this information to evaluate 
overseas panel physician performance and overseas prevention 
activities. To evaluate panel physician performance and overseas TB 
prevention activities, CDC needs to know the results of domestic chest 
x-rays (CXR), CXR comparison sputum smears and cultures, and TB 
diagnoses along with domestic reviews of overseas treatment.
    There are no costs to respondents except their time to complete the 
questionnaires. The annualized burden for this data collection is 2,322 
hours.

[[Page 14923]]



                                        Estimated Annualized Burden Hours
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                                                                                      Average
                                                     Number of       Number of      burden per     Total burden
      Type of respondents           Form name       respondents    responses per   response  (in    (in hours)
                                                                    respondent        hours)
----------------------------------------------------------------------------------------------------------------
EDN data entry staff at state   The EDN                    1,548               3           30/60           2,322
 and local health departments.   Tuberculosis
                                 Follow-Up
                                 Worksheet for
                                 Newly-Arrived
                                 Persons with
                                 Overseas
                                 Tuberculosis
                                 Classifications.
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............           2,322
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Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific 
Integrity, Office of Science, Centers for Disease Control and 
Prevention.
[FR Doc. 2021-05762 Filed 3-18-21; 8:45 am]
BILLING CODE 4163-18-P