83 FR 13752 - Proposed Data Collection Submitted for Public Comment and Recommendations
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention Federal Register Volume 83, Issue 62 (March 30, 2018)
Centers for Disease Control and Prevention
Federal Register Volume 83, Issue 62 (March 30, 2018)
| Page Range | 13752-13754 | |
| FR Document | 2018-06487 |
[Federal Register Volume 83, Number 62 (Friday, March 30, 2018)] [Notices] [Pages 13752-13754] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-06487] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60Day-18-18TH; Docket No. CDC-2018-0027] 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 ``Assessment of a Preventive Service Program in the Context of a Zika [[Page 13753]] Virus Outbreak in Puerto Rico''. Data collected will be used to assess implementation of a patient-centered prevention program and associated outcomes. DATES: CDC must receive written comments on or before May 29, 2018. ADDRESSES: You may submit comments, identified by Docket No. CDC-2018- 0027 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 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 Assessment of a Preventive Service Program in the Context of a Zika Virus Outbreak in Puerto Rico--New--National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), Centers for Disease Control and Prevention (CDC). Background and Brief Description Puerto Rico has reported the highest number of Zika virus infections in the United States, including infections in pregnant women. Zika virus infection during pregnancy has been identified as a cause of microcephaly and other severe brain abnormalities, and has been linked to other problems such as miscarriage, stillbirth, defects of the eye, hearing deficits, limb abnormalities, and impaired growth. One strategy to prevent these devastating outcomes is to prevent unintended pregnancy among women at risk of Zika virus infection. To this end, an initiative was launched in April 2016 to train physicians at clinics across Puerto Rico to provide patient-centered services to women who chose to delay or avoid pregnancy during the Zika virus outbreak. As part of the public health response to the Zika virus outbreak, CDC seeks to assess approaches to mitigating the effects of Zika virus infection and determine which approaches have utility. Previous assessment of the prevention program indicated high satisfaction of Z- CAN patients with program services. The specific objectives of this data collection are to assess: (1) Prevention strategy adherence among Z-CAN patients at approximately 18 months after receipt of program services; and (2) prevention strategy adherence, patient satisfaction, and unmet need for services among Z-CAN patients at approximately 30 months after receipt of program services. The practical utility of the collected information is to assess services delivered to women in Puerto Rico, monitor outcomes of interest, and determine potential for replication/adaptation in other jurisdictions similarly affected by the Zika virus or during other emergency responses. For the information collection project, CDC plans to conduct online surveys with 1,600 patients approximately 18 and 30 months after receiving program services. Participation in all data collection activities will be completely voluntary. CDC intends to request a two-year OMB approval to collect information. Total Annualized Burden Hours are estimated to be 259, and there are no costs to respondents other than their time. Estimated Annualized Burden Hours -------------------------------------------------------------------------------------------------------------------------------------------------------- Average Number of Number of burden per Total burden Type of respondents Form name respondents responses per response (in (in hours) respondent hours) -------------------------------------------------------------------------------------------------------------------------------------------------------- Patients aged 18 years or older................ Online surveys (18-month follow-up).... 960 1 7/60 112 Patients aged 18 years or older who completed Online surveys (30-month follow-up).... 660 1 10/60 110 18-month survey. Patients aged 18 years or older who did not Online surveys (30-month follow-up).... 220 1 10/60 37 complete 18-month survey. --------------------------------------------------------------- Total...................................... ....................................... .............. .............. .............. 259 -------------------------------------------------------------------------------------------------------------------------------------------------------- [[Page 13754]] 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. 2018-06487 Filed 3-29-18; 8:45 am] BILLING CODE 4163-18-P
![13752 Federal Register / Vol. 83, No. 62 / Friday, March 30, 2018 / Notices
Background and Brief Description consequences of tobacco use and collaborative efforts with other federal
In 2012, CDC’s Office on Smoking and exposure to secondhand smoke. The partners including, but not limited to,
Health obtained OMB approval of a MTTCA clearance has also supported the Food and Drug Administration’s
generic clearance to support the formative research relating to the Center for Tobacco Products. At this
development and testing of tobacco- development of health messages that are time, the respondents and burden
related health messages, including not specifically associated with the outlined in the existing MTTCA
messages disseminated through national campaign. clearance are expected to be sufficient to
multiple phases of a media campaign Information collection modes under test tobacco related messages developed
(Message Testing for Tobacco the MTTCA clearance that are by CDC for the general US population
Communication Activities (MTTCA), supported include in-depth interviews; and subpopulations of interest. The
OMB Control Number 0920–0910, in-person focus groups; online focus MTTCA clearance should not replace
expiration date 1/31/2015). In 2014, groups; computer-assisted, in-person, or the need for additional generic
OSH obtained approval for a telephone interviews; and online clearance mechanisms of HHS and other
modification to the MTTCA clearance surveys. Each project approved under federal partners that may need to test
that granted a three-year extension and the MTTCA framework is outlined in a tobacco messages related to their
an increase in respondents and burden project-specific Information Collection campaigns and initiatives.
hours (MTTCA, OMB Control Number Request that describes its purpose and
methodology. Messages developed from The existing MTTCA clearance was
0920–0910, expiration date 3/31/2018).
MTTCA data collection have been granted approval for a total of 132,648
CDC’s authority to collect information
disseminated via multiple media respondents and 32,994 burden hours
for public health purposes is provided
channels including television, radio, over a three-year period (annualized
by the Public Health Service Act (41
U.S.C. 241) Section 301. print, out-of-home, and digital formats. number of respondents of 44,216 and
CDC has employed the MTTCA CDC requests OMB approval to extend annualized burden hours to 10,998). To
clearance to collect information about the MTTCA clearance, without changes, date, there have been 63,475
adult smokers’ and nonsmokers’ for three years. No modification is respondents and 11,737 burden hours
attitudes and perceptions, and to pretest requested for information collection used in this clearance, leaving a balance
draft messages and materials for clarity, activities, methodology, respondents, or of 69,173 respondents and 21,257
salience, appeal, and persuasiveness. burden from the existing generic burden hours (annualized number of
The MTTCA clearance has been used to clearance. The extension is needed to respondents of 23,057 and annualized
obtain OMB approval for a variety of support CDC’s planned information burden hours to 7,085 for each of the
message testing activities, with collections and to accommodate three years in the requested extension).
particular emphasis on communications additional needs that CDC may identify CDC will continue to use the MTTCA
supporting CDC’s National Tobacco during the next three years. For information collection plan to develop
Education Campaign (NTEC) called the example, the MTTCA generic clearance and test messages and materials.
Tips from Former Smokers® campaign. may be used to facilitate the Participation is voluntary and there are
This national campaign is designed to development of tobacco-related health no costs to respondents, other than their
increase public awareness of the health communications of interest for CDC’s time.
ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of
Number of burden per Total burden
Type of respondents Form name responses per
respondents response (in hours)
respondent (in hours)
General Public and Special Popu- Screening ......................................... 23,057 1 2/60 769
lations.
Short Surveys/employment applica- 13,224 1 10/60 2,204
tion (Online, Bulletin Board, etc.).
Medium Surveys (Online) ................ 9,833 1 25/60 4,097
Total ........................................... ........................................................... 23,057 ........................ ........................ 7,070
Leroy A. Richardson, DEPARTMENT OF HEALTH AND ACTION: Notice with comment period.
Chief, Information Collection Review Office, HUMAN SERVICES
Office of Scientific Integrity, Office of the SUMMARY: The Centers for Disease
Associate Director for Science, Office of the Centers for Disease Control and Control and Prevention (CDC), as part of
Director, Centers for Disease Control and Prevention its continuing effort to reduce public
Prevention. burden and maximize the utility of
[FR Doc. 2018–06392 Filed 3–29–18; 8:45 am] [60Day–18–18TH; Docket No. CDC–2018– government information, invites the
BILLING CODE 4163–18–P 0027] general public and other Federal
agencies the opportunity to comment on
amozie on DSK30RV082PROD with NOTICES
Proposed Data Collection Submitted a proposed and/or continuing
for Public Comment and information collection, as required by
Recommendations the Paperwork Reduction Act of 1995.
This notice invites comment on a
AGENCY: Centers for Disease Control and proposed information collection project
Prevention (CDC), Department of Health titled ‘‘Assessment of a Preventive
and Human Services (HHS). Service Program in the Context of a Zika
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![13754 Federal Register / Vol. 83, No. 62 / Friday, March 30, 2018 / Notices
Leroy A. Richardson, Deadline for Registration of Presenters consultation in a manner consistent
Chief, Information Collection Review Office, and Submission of Presentations: All with the procedures established for
Office of Scientific Integrity, Office of the presenters for the Annual Laboratory implementing coding modifications for
Associate Director for Science, Office of the Public Meeting must register and submit International Classification of Diseases
Director, Centers for Disease Control and their presentations electronically to our (ICD–9–CM) (now, ICD–10–CM). The
Prevention. CLFS dedicated email box, CLFS_ procedures and clinical laboratory fee
[FR Doc. 2018–06487 Filed 3–29–18; 8:45 am] Annual_Public_Meeting@cms.hhs.gov, schedule (CLFS) public meeting
BILLING CODE 4163–18–P by June 11, 2018 at 5:00 p.m. E.D.T. announced in this notice for new tests
Deadline for Submitting Requests for are in accordance with the procedures
Special Accommodations: Requests for published on November 23, 2001 in the
DEPARTMENT OF HEALTH AND special accommodations must be Federal Register (66 FR 58743) to
HUMAN SERVICES received no later than 5:00 p.m. E.D.T. implement section 531(b) of BIPA.
on June 11, 2018. Section 942(b) of the Medicare
Centers for Medicare & Medicaid Prescription Drug, Improvement, and
Deadline for Submission of Written
Services Modernization Act of 2003 (MMA) (Pub.
Comments Related to the Annual
[CMS–1697–N] Laboratory Public Meeting: Written L. 108–173) added section 1833(h)(8) of
comments regarding the presentations the Act. Section 1833(h)(8)(A) of the Act
Medicare Program; Public Meeting on must be received by July 9, 2018 at 5:00 requires the Secretary to establish by
June 25, 2018 Regarding New and p.m. E.D.T. (2 weeks after the meeting). regulation procedures for determining
Reconsidered Clinical Diagnostic Publication of Proposed the basis for, and amount of, payment
Laboratory Test Codes for the Clinical Determinations: We intend to publish for any clinical diagnostic laboratory
Laboratory Fee Schedule for Calendar our proposed determinations for new test for which a new or substantially
Year 2019 test codes and our preliminary revised Healthcare Common Procedure
determinations for reconsidered codes Coding System (HCPCS) code is
AGENCY: Centers for Medicare &
(as described later in this notice in assigned on or after January 1, 2005
Medicaid Services (CMS), HHS. (hereinafter referred to as ‘‘new tests’’).
section II. ‘‘Format’’) for CY 2019 by
ACTION: Notice. A code is considered to be substantially
early September 2018.
SUMMARY: This notice announces a Deadline for Submission of Written revised if there is a substantive change
public meeting to receive comments and Comments Related to Proposed to the definition of the test or procedure
Determinations: Comments in response to which the code applies (such as, a
recommendations (including
to the preliminary determinations will new analyte or a new methodology for
accompanying data on which
be due by early October 2018. measuring an existing analyte-specific
recommendations are based) from the
Where to Submit Written Comments: test). (See section 1833(h)(8)(E)(ii) of the
public on the appropriate basis for
Interested parties should submit all Act and 42 CFR 414.502).
establishing payment amounts for new Section 1833(h)(8)(B) of the Act sets
or substantially revised Healthcare written comments on presentations and
preliminary determinations to the forth the process for determining the
Common Procedure Coding System basis for, and the amount of, payment
(HCPCS) codes being considered for address specified in the ADDRESSES
section of this notice or electronically to for new tests. Pertinent to this notice,
Medicare payment under the clinical sections 1833(h)(8)(B)(i) and (ii) of the
laboratory fee schedule (CLFS) for our CLFS dedicated email box, CLFS_
Annual_Public_Meeting@cms.hhs.gov Act require the Secretary to make
calendar year (CY) 2019. This meeting available to the public a list that
also provides a forum for those who (the specific date for the publication of
these determinations on the CMS includes any such test for which
submitted certain reconsideration establishment of a payment amount is
requests regarding final determinations website, as well as the deadline for
submitting comments regarding these being considered for a year and, on the
made last year on new test codes and for same day that the list is made available,
the public to provide comment on the determinations, will be published on
the CMS website). causes to have published a notice in the
requests. Federal Register of a meeting to receive
The Medicare Advisory Panel on ADDRESSES: The Annual Laboratory
comments and recommendations
Clinical Diagnostic Laboratory Tests Public Meeting will be held in the main (including accompanying data on which
(Advisory Panel on CDLTs) will auditorium of the Centers for Medicare recommendations are based) from the
participate in this Annual Laboratory & Medicaid Services (CMS), Central public on the appropriate basis for
Public Meeting by gathering information Building, 7500 Security Boulevard, establishing payment amounts for the
and asking questions to presenters, and Baltimore, Maryland 21244–1850. tests on such list. This list of codes for
will hold its next public meeting on July FOR FURTHER INFORMATION CONTACT: which the establishment of a payment
16 and 17, 2018. The public meeting for Glenn McGuirk, (410) 786–5723. amount under the CLFS is being
the Advisory Panel on CDLTs will focus SUPPLEMENTARY INFORMATION: considered for CY 2019 will be posted
on discussion of and recommendations on the CMS website concurrent with the
for test codes presented during the June I. Background
publication of this notice and may be
25, 2018 Annual Laboratory Public Section 531(b) of the Medicare, updated prior to the Annual Laboratory
Meeting. The Panel meeting also will Medicaid, and SCHIP Benefits Public Meeting. The Annual Laboratory
address other CY 2019 CLFS issues that Improvement and Protection Act of Public Meeting list of codes can be
are designated in the Panel’s charter and 2000 (BIPA) (Pub. L. 106–554) required found on the CMS website at http://
amozie on DSK30RV082PROD with NOTICES
specified on the meeting agenda may the Secretary of the Department of www.cms.gov/Medicare/Medicare-Fee-
also be discussed. Health and Human Services (the for-Service-Payment/
DATES: Secretary) to establish procedures for ClinicalLabFeeSched/
Annual Laboratory Public Meeting coding and payment determinations for index.html?redirect=/
Date: The meeting is scheduled for new clinical diagnostic laboratory tests ClinicalLabFeeSched/. Section
Monday, June 25, 2018 from 8:00 a.m. under Part B of title XVIII of the Social 1833(h)(8)(B)(iii) of the Act requires that
to 5:00 p.m., E.D.T. Security Act (the Act) that permit public we convene the public meeting not less
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Document Created: 2018-11-01 08:58:26
Document Modified: 2018-11-01 08:58:26
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice with comment period. | |
| Dates | CDC must receive written comments on or before May 29, 2018. | |
| 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] | |
| FR Citation | 83 FR 13752 |
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