80 FR 76992 - Agency Forms Undergoing Paperwork Reduction Act Review
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention Federal Register Volume 80, Issue 238 (December 11, 2015)
Centers for Disease Control and Prevention
Federal Register Volume 80, Issue 238 (December 11, 2015)
| Page Range | 76992-76994 | |
| FR Document | 2015-31226 |
[Federal Register Volume 80, Number 238 (Friday, December 11, 2015)] [Notices] [Pages 76992-76994] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-31226] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30Day-16-0950] Agency Forms Undergoing Paperwork Reduction Act Review The Centers for Disease Control and Prevention (CDC) has submitted the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. The notice for the proposed information collection is published to obtain comments from the public and affected agencies. Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address any of the following: (a) 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; (b) Evaluate the accuracy of the agencies estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (c) Enhance the quality, utility, and clarity of the information to be collected; (d) Minimize the burden of [[Page 76993]] 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 submission of responses; and (e) Assess information collection costs. To request additional information on the proposed project or to obtain a copy of the information collection plan and instruments, call (404) 639-7570 or send an email to [email protected]. Direct written comments and/or suggestions regarding the items contained in this notice to the Attention: CDC Desk Officer, Office of Management and Budget, Washington, DC 20503 or by fax to (202) 395-5806. Written comments should be received within 30 days of this notice. Proposed Project The National Health and Nutrition Examination Survey (NHANES), (OMB No. 0920-0950, expires 11/30/2016)--Revision--National Center for Health Statistics (NCHS), Centers for Disease Control and Prevention (CDC). Background and Brief Description Section 306 of the Public Health Service (PHS) Act (42 U.S.C. 242k), as amended, authorizes that the Secretary of Health and Human Services (DHHS), acting through NCHS, shall collect statistics on the extent and nature of illness and disability; environmental, social and other health hazards; and determinants of health of the population of the United States. The National Health and Nutrition Examination Surveys (NHANES) have been conducted periodically between 1970 and 1994, and continuously since 1999 by the National Center for Health Statistics, CDC. Annually, approximately 14,410 respondents participate in some aspect of the full survey. Up to 3,500 additional persons might participate in tests of procedures, special studies, or methodological studies (Table 1). Participation in NHANES is completely voluntary and confidential. A three-year approval is requested. NHANES programs produce descriptive statistics which measure the health and nutrition status of the general population. Through the use of physical examinations, laboratory tests, and interviews NHANES studies the relationship between diet, nutrition and health in a representative sample of the United States. NHANES monitors the prevalence of chronic conditions and risk factors. NHANES data are used to produce national reference data on height, weight, and nutrient levels in the blood. Results from more recent NHANES can be compared to findings reported from previous surveys to monitor changes in the health of the U.S. population over time. NCHS collects personal identification information. Participant level data items will include basic demographic information, name, address, social security number, Medicare number and participant health information to allow for linkages to other data sources such as the National Death Index and data from the Centers for Medicare and Medicaid Services (CMS). A variety of agencies sponsor data collection components on NHANES. To keep burden down, NCHS cycles in and out various components. The 2015-2016 NHANES physical examination includes the following components: Oral glucose tolerance test (ages 12 and older), anthropometry (all ages), 24-hour dietary recall (all ages), physician's examination (all ages, blood pressure is collected here), oral health examination (ages 1 and older), hearing (ages 20-59), dual X-ray absorptiometry (total body composition ages 6-59 and osteoporosis, vertebral fractures and aortic calcification ages 40 and older). While at the examination center additional interview questions are asked (6 and older), a second 24-hour dietary recall (all ages) is scheduled to be conducted by phone 3-10 days later, and an appointment is made to return to the MEC to begin a 24-hour urine collection (one- half sample of ages 20- 69). In 2014, a 24-hour urine collection was added to the NHANES protocol to better understand sodium intake and provide a population baseline for use in monitoring trends in sodium intake in the future. In 2015, FDA is scheduled to implement a plan to promote broad, gradual reduction of added sodium in the food supply. One half of those successfully completing the initial collection will be asked to complete a second 24-hour urine. After completing the 24- hour urine participants are asked to provide 2 home urine collections (first morning and an evening) and mail them back. The urines collected in the morning and evening will be compared to the 24-hour urine collection. NHANES also plans to conduct a waist circumference methodology study. The study population will be NHANES participants aged 20 and over who participate in the body measurements component in the Mobile Examination Center (MEC). The bio-specimens collected for laboratory tests include urine, blood, vaginal and penile swabs, oral rinses and household water collection. Serum, plasma and urine specimens are stored for future testing if the participant consents. The following major examination or laboratory items, that had been included in the 2013-2014 NHANES, were cycled out for NHANES 2015-2016: Physical activity monitor, taste and smell component and upper body muscle strength (grip test). Most sections of the NHANES interviews provide self-reported information to be used either in concert with specific examination or laboratory content, as independent prevalence estimates, or as covariates in statistical analysis (e.g., socio-demographic characteristics). Some examples include alcohol, drug, and tobacco use, sexual behavior, prescription and aspirin use, and indicators of oral, bone, reproductive, and mental health. Several interview components support the nutrition monitoring objective of NHANES, including questions about food security and nutrition program participation, dietary supplement use, and weight history/self-image/related behavior. NHANES data users include the U.S. Congress; numerous Federal agencies such as other branches of the Centers for Disease Control and Prevention, the National Institutes of Health, and the United States Department of Agriculture; private groups such as the American Heart Association; schools of public health; and private businesses. There is no cost to respondents other than their time. Estimated Annualized Burden Hours ---------------------------------------------------------------------------------------------------------------- Average Number of Number of burden per Type of respondents Form name respondents responses per response (in respondent hrs.) ---------------------------------------------------------------------------------------------------------------- Individuals in households............. NHANES Questionnaire.... 14,410 1 2.5 Individuals in households............. Waist Circumference 3,000 1 8/60 Methodology Study. [[Page 76994]] Individuals in households............. Special Studies......... 3,500 1 3 ---------------------------------------------------------------------------------------------------------------- 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. 2015-31226 Filed 12-10-15; 8:45 am] BILLING CODE 4163-18-P
![76992 Federal Register / Vol. 80, No. 238 / Friday, December 11, 2015 / Notices
completeness of the evidence in the believes, will increase the value of related to medical interventions
systematic reviews may also address AHRQ’s research reviews to end users sponsored by organizations and
this issue. and potentially provide stakeholders a individuals such as pharmaceutical
The proposed project does not better understanding of how their companies and independent
duplicate other available sources of this submissions are used. researchers. The form has three required
information. Available study registries fields: The organization’s name, the
and databases may not be complete to Estimated Annual Respondent Burden
intervention in question, and whether
sufficiently inform the Program’s Exhibit 1 presents estimates of the the information they provide is all the
research. reporting burden hours for the data information they know to exist. They
The purpose of SEADS requests is not collection efforts. Time estimates are
may upload documents and they are
to collect generalizable data, but to based on pilot testing of materials and
also provided a data entry form if they
supplement the published and grey what can reasonably be requested of
wish to offer greater details on their
literature searches EPC investigators are respondents. The number of
conducting. Furthermore, considering studies.
respondents listed in ‘‘Number of
the evidence and data included in respondents per SEADS request’’ of An Optional Data Entry Form is
responses collected from industry Exhibit 1 reflects a projected 80% available as an alternative to the Online
stakeholders, an assessment pertaining response rate. Submission form. The time
to the completeness of the evidence- Online Submission Form: A form for requirements for response would be
base will be produced. This, AHRQ submitting scientific evidence and data same as the Online Submission Form.
EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS
Number of Number of Total burden
respondents Hours per
Form name responses per hours per
per SEADS response
respondent SEADS
request
Online Submission Form (OSF) ...................................................................... 70 1 15/60 17.5
Total .......................................................................................................... 70 1 15/60 17.5
EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN
Number of Total burden Average Total cost
Form name SEADS hours per hourly wage burden
requests SEADS rate *
OSF .................................................................................................................. 70 17.5 a $55.48 $970.90
Total .......................................................................................................... 70 17.5 55.48 970.90
* Occupational Employment Statistics, May 2014 National Occupational Employment and Wage Estimates United States, U.S. Department of
Labor, Bureau of Labor Statistics. http://www.bls.gov/oes/current/oes_nat.htm#b29-0000.
a Based on the mean wages for Public Relations and Fundraising Managers, 11–2031, the occupational group most likely tasked with com-
pleting the OSF.
Request for Comments included in the Agency’s subsequent to the Office of Management and Budget
request for OMB approval of the (OMB) for review and approval in
In accordance with the Paperwork proposed information collection. All accordance with the Paperwork
Reduction Act, comments on AHRQ’s comments will become a matter of Reduction Act of 1995. The notice for
information collection are requested public record. the proposed information collection is
with regard to any of the following: (a) published to obtain comments from the
Whether the proposed collection of Sharon Arnold,
public and affected agencies.
information is necessary for the proper Deputy Director. Written comments and suggestions
performance of AHRQ health care [FR Doc. 2015–31159 Filed 12–10–15; 8:45 am] from the public and affected agencies
research and health care information BILLING CODE 4160–90–P concerning the proposed collection of
dissemination functions, including information are encouraged. Your
whether the information will have comments should address any of the
practical utility; (b) the accuracy of DEPARTMENT OF HEALTH AND following: (a) Evaluate whether the
AHRQ’s estimate of burden (including HUMAN SERVICES proposed collection of information is
hours and costs) of the proposed necessary for the proper performance of
collection(s) of information; (c) ways to Centers for Disease Control and the functions of the agency, including
enhance the quality, utility, and clarity Prevention whether the information will have
of the information to be collected; and practical utility; (b) Evaluate the
jstallworth on DSK7TPTVN1PROD with NOTICES
(d) ways to minimize the burden of the [30Day–16–0950] accuracy of the agencies estimate of the
collection of information upon the burden of the proposed collection of
respondents, including the use of Agency Forms Undergoing Paperwork
Reduction Act Review information, including the validity of
automated collection techniques or the methodology and assumptions used;
other forms of information technology. The Centers for Disease Control and (c) Enhance the quality, utility, and
Comments submitted in response to Prevention (CDC) has submitted the clarity of the information to be
this notice will be summarized and following information collection request collected; (d) Minimize the burden of
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![76994 Federal Register / Vol. 80, No. 238 / Friday, December 11, 2015 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Average
Number of
Number of burden per
Type of respondents Form name responses per
respondents response
respondent (in hrs.)
Individuals in households ................................ Special Studies .............................................. 3,500 1 3
Leroy A. Richardson, recommendations must be submitted in CMS–855O Medicare Registration
Chief, Information Collection Review Office, any one of the following ways: Application
Office of Scientific Integrity, Office of the
Associate Director for Science, Office of the 1. Electronically. You may send your CMS–10438 Data Collection To
Director, Centers for Disease Control and comments electronically to http:// Support Eligibility Determinations and
Prevention. www.regulations.gov. Follow the Enrollment for Employees in the Small
[FR Doc. 2015–31226 Filed 12–10–15; 8:45 am] instructions for ‘‘Comment or Business Health Options Program
BILLING CODE 4163–18–P Submission’’ or ‘‘More Search Options’’ CMS–10439 Data Collection To
to find the information collection Support Eligibility Determinations and
document(s) that are accepting Enrollment for Employers in the Small
DEPARTMENT OF HEALTH AND comments. Business Health Options Program
HUMAN SERVICES 2. By regular mail. You may mail Under the PRA (44 U.S.C. 3501–
Centers for Medicare & Medicaid written comments to the following 3520), federal agencies must obtain
Services address: CMS, Office of Strategic approval from the Office of Management
Operations and Regulatory Affairs, and Budget (OMB) for each collection of
[Document Identifier: CMS–855O, CMS– Division of Regulations Development, information they conduct or sponsor.
10438 and CMS–10439] The term ‘‘collection of information’’ is
Attention: Document Identifier/OMB
Agency Information Collection Control Number ll, Room C4–26–05, defined in 44 U.S.C. 3502(3) and 5 CFR
Activities: Proposed Collection; 7500 Security Boulevard, Baltimore, 1320.3(c) and includes agency requests
Comment Request Maryland 21244–1850. or requirements that members of the
public submit reports, keep records, or
AGENCY: Centers for Medicare & To obtain copies of a supporting provide information to a third party.
Medicaid Services, HHS. statement and any related forms for the Section 3506(c)(2)(A) of the PRA
ACTION: Notice. proposed collection(s) summarized in requires federal agencies to publish a
this notice, you may make your request 60-day notice in the Federal Register
SUMMARY: The Centers for Medicare & using one of following: concerning each proposed collection of
Medicaid Services (CMS) is announcing information, including each proposed
1. Access CMS’ Web site address at
an opportunity for the public to extension or reinstatement of an existing
http://www.cms.hhs.gov/
comment on CMS’ intention to collect collection of information, before
information from the public. Under the PaperworkReductionActof1995.
submitting the collection to OMB for
Paperwork Reduction Act of 1995 (the 2. Email your request, including your approval. To comply with this
PRA), federal agencies are required to address, phone number, OMB number, requirement, CMS is publishing this
publish notice in the Federal Register and CMS document identifier, to notice.
concerning each proposed collection of Paperwork@cms.hhs.gov. 1. Type of Information Collection
information (including each proposed 3. Call the Reports Clearance Office at Request: Revision of a currently
extension or reinstatement of an existing (410) 786–1326. approved information collection; Title
collection of information) and to allow of Information Collection: Medicare
60 days for public comment on the FOR FURTHER INFORMATION CONTACT: Registration Application; Use: The
proposed action. Interested persons are Reports Clearance Office at (410) 786– primary function of the CMS–8550 is to
invited to send comments regarding our 1326. gather information from a physician or
burden estimates or any other aspect of other eligible professional to help CMS
this collection of information, including SUPPLEMENTARY INFORMATION:
determine whether he or she meets
any of the following subjects: the Contents certain qualifications to be enrolled in
necessity and utility of the proposed the Medicare program for the sole
information collection for the proper This notice sets out a summary of the purpose of ordering or certifying certain
performance of the agency’s functions; use and burden associated with the Medicare items or services and/or
the accuracy of the estimated burden; following information collections. More prescribing Medicare Part D drugs for
ways to enhance the quality, utility, and detailed information can be found in Medicare beneficiaries. The application
clarity of the information to be each collection’s supporting statement allows a physician or other eligible
collected; and the use of automated and associated materials (see professional to enroll in Medicare
collection techniques or other forms of ADDRESSES). without being approved for billing
information technology to minimize the privileges. The required information is
jstallworth on DSK7TPTVN1PROD with NOTICES
information collection burden. submitted when the applicant requests
DATES: Comments must be received by enrollment in Medicare for the sole
February 9, 2016. purpose of ordering and certifying
ADDRESSES: When commenting, please certain Medicare items and services or
reference the document identifier or for prescribing Medicare Part D drugs.
OMB control number. To be assured The application is used by Medicare
consideration, comments and contractors to collect data to help ensure
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Document Created: 2018-03-02 09:12:58
Document Modified: 2018-03-02 09:12:58
| 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 | |
| FR Citation | 80 FR 76992 |
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