[Federal Register Volume 83, Number 21 (Wednesday, January 31, 2018)]
[Notices]
[Pages 4484-4486]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-01805]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60-day-18-18KG; Docket No. CDC-2018-0013]
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 Information Collection for U.S.
Tuberculosis Follow-up Worksheet for Newly-Arrived Persons with
Overseas Tuberculosis Classifications--CDC is proposing a TB follow-up
worksheet 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 April 2, 2018.
ADDRESSES: You may submit comments, identified by Docket No. CDC-2018-
0013 by any of the following methods:
Federal eRulemaking Portal: Regulations.gov. Follow the
instructions for submitting comments.
Mail: Leroy A. Richardson, 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 Leroy A. Richardson, Information Collection
Review Office, Centers for Disease Control and Prevention, 1600 Clifton
Road, NE, MS-D74, Atlanta, Georgia 30329; phone: 404-639-7570; 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
[[Page 4485]]
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 U.S. Tuberculosis Follow-up Worksheet
for Newly-Arrived Persons with Overseas Tuberculosis Classifications--
Existing Information Collection in Use Without an OMB Control Number--
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 up evaluations including CXR,
diagnosis, 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-ray (CXR), CXR comparison sputum smear and culture, and TB diagnosis
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 2,200
hours.
Estimated Annualized Burden Hours
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Number of Average burden
Type of respondents Form name Number of responses per per response Total burden
respondents respondent (in hours) (in hours)
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EDN data entry staff at state and local health U.S. Tuberculosis Follow-up Worksheet 550 48 5/60 2,200
departments. for Newly-Arrived Persons with
Overseas Tuberculosis Classifications.
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
Total...................................... ....................................... .............. .............. .............. 2,200
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[[Page 4486]]
Leroy A. Richardson,
Chief, Information Collection Review Office, Office of Scientific
Integrity, Office of the Associate Director for Science, Office of the
Director, Centers for Disease Control and Prevention.
[FR Doc. 2018-01805 Filed 1-30-18; 8:45 am]
BILLING CODE 4163-18-P