80 FR 52292 - Proposed Data Collection Submitted for Public Comment and Recommendations
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention Federal Register Volume 80, Issue 167 (August 28, 2015)
Centers for Disease Control and Prevention
Federal Register Volume 80, Issue 167 (August 28, 2015)
| Page Range | 52292-52294 | |
| FR Document | 2015-21344 |
[Federal Register Volume 80, Number 167 (Friday, August 28, 2015)] [Notices] [Pages 52292-52294] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-21344] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60Day-15-15BEB; Docket No. CDC-2015-0071] 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 efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collect project entitled Balance After Baby Intervention: Phase 2 (BABI2.) A three-year clearance is requested to conduct a randomized controlled trial of a Web site-based lifestyle program with a racially diverse population of postpartum women who had recent Gestational diabetes mellitus (GDM). DATES: Written comments must be received on or before October 27, 2015. ADDRESSES: You may submit comments, identified by Docket No. CDC-2015- 0071 by any of the following methods: Federal eRulemaking Portal: Regulation.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. All relevant comments received will be posted without change to Regulations.gov, including any personal information provided. For access to the docket to read background documents or comments received, go to Regulations.gov. Please note: All public comment should be submitted 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 the Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS- D74, Atlanta, Georgia 30329; phone: 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 OMB for approval. To comply with this requirement, we are publishing this notice of a proposed data collection as described below. Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology; and (e) estimates of capital or start- up costs and costs of operation, maintenance, and purchase of services to provide information. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; to develop, acquire, install and utilize technology and systems for the purpose of collecting, validating and verifying information, processing and maintaining information, and disclosing [[Page 52293]] and providing information; to train personnel and to be able to respond to a collection of information, to search data sources, to complete and review the collection of information; and to transmit or otherwise disclose the information. Proposed Project Balance After Baby Intervention: Phase 2 (BABI2)--New--National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), Centers for Disease Control and Prevention (CDC). Background and Brief Description The CDC Division of Reproductive Health (DRH) is focused on understanding and preventing complications due to pregnancy and the development of chronic diseases in reproductive age women. Similarly, the CDC established the National Diabetes Prevention Program (NDPP), administered through the Division of Diabetes Translation (DDT), to make strategies for preventing type 2 diabetes broadly available to individuals at high risk of developing diabetes. Gestational diabetes mellitus (GDM) is one of the most common pregnancy complications in the US, affecting approximately 3-13% of pregnancies, or approximately 200,000 cases annually. As defined by the American Diabetes Association (2003), GDM is glucose intolerance that first presents during pregnancy after the first trimester. Women with a history of GDM have a substantially increased risk of developing type 2 diabetes mellitus (T2DM) within 5 to 16 years after their index pregnancy. It has also been shown that many women with a history of GDM gain weight after pregnancy, increasing their risk for obesity, which itself is a strong risk factor for repeat GDM and T2DM. Because of this, as US obesity prevalence continues to increase, there is a concurrent rise in the incidence and prevalence of GDM and T2DM, resulting in a large disease burden on individuals, families, and society. To assist in reducing this national disease burden, it is critical to develop and implement successful interventions that reduce the annual number of newly diagnosed T2DM cases, especially in increased risk populations, such as women with a history of GDM. As part of this Healthy People 2020 objective, the Diabetes Prevention Program (DPP) demonstrated that an intensive lifestyle intervention (16 face-to-face sessions over a 24- week period) promoting physical activity, healthy eating, and weight reduction significantly decreased T2DM incidence by 58% in high risk patients. However, the DPP included predominantly older individuals whose ability to attend group meetings and adopt healthy lifestyle changes is different than younger postpartum women. For this reason, successful adaptations of the DPP that address barriers in postpartum women with recent GDM, such as limited time and resources, fatigue, and childcare demands, must be identified and tested. This BABI2 data collection request aims to address these barriers through the conduct of a randomized, controlled intervention trial of a Web site-based lifestyle program, Balance after Baby (BAB) that is adapted from the DPP and tailored specifically for postpartum women with recent GDM. The project aims to screen 293 (98 annualized over 3 years) women with a recent GDM pregnancy for enrollment into the study, followed by assessments at the following five post-partum time points: 6-weeks, 6- months, 12-months, 18-months, and 24-months. Of the estimated 190 (63 annualized) women who will meet eligibility requirements and attend the first study visit, approximately half will be assigned to the control group and will receive standard postpartum follow-up, while those assigned to the intervention group will have access to the BAB informational Web site and a lifestyle coach. For all participants, the BABI2 study visits will involve the completion of visit-specific questionnaires, laboratory testing, and the collection of physical measurements such as height and weight. Collected data will be used by CDC and BABI2 investigators to assess the impact and effectiveness of the BABI2 intervention as a potential public health weight loss tool for women at increased T2DM risk. For the calculation of the estimated burden hours per study visit detailed in the table below, a constant 5% rate of exclusion and attrition was applied between visits. The burden table provides a participant estimate, which will be evenly distributed across control and intervention groups for each information collection step, annualized over a 3-year collection period. Therefore, of the 190 women (63 annualized) who attend the 6-week visit, the estimated number of participants returning for the 6-month visit is reduced to 180 (60 annualized), followed by 172 (57 annualized), 162 (54 annualized), and 154 (51 annualized) for the 12-, 18-, and 24-month visits respectively. The average burden per questionnaire ranges from 8 minutes for the BABI2 Screener Questionnaire up to 36 minutes for the BABI2 6-month Questionnaire. Estimated Annualized Burden Hours -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of Average burden Type of respondents Form name Number of responses per per response Total burden respondents respondent (in hrs.) (in hrs.) -------------------------------------------------------------------------------------------------------------------------------------------------------- Women with a recent history GDM................ BABI2 Screener Questionnaire........... 98 1 8/60 13 Women with a recent history GDM................ BABI2 6-Week Questionnaire............. 63 1 35/60 37 Women with a recent history GDM................ BABI2 6-Month Questionnaire............ 60 1 36/60 36 Women with a recent history GDM................ BABI2 12-Month Questionnaire........... 57 1 32/60 31 Women with a recent history GDM................ BABI2 18-Month Questionnaire........... 54 1 32/60 29 Women with a recent history GDM................ BABI2 24-Month Questionnaire........... 51 1 33/60 28 --------------------------------------------------------------- Total...................................... ....................................... .............. .............. .............. 174 -------------------------------------------------------------------------------------------------------------------------------------------------------- [[Page 52294]] 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. 2015-21344 Filed 8-27-15; 8:45 am] BILLING CODE 4163-18-P
![52292 Federal Register / Vol. 80, No. 167 / Friday, August 28, 2015 / Notices
respondents through an online survey, and awareness of the National CLAS as the basis to provide regional and
paper form or telephone administration. Standards. national estimates. Participation in the
Information that will be collected The target universe of the CLAS CLAS survey is voluntary. There will be
includes demographic information, survey includes non-federally employed no financial incentive to participate.
specialty, number of years the physician physicians who were classified by the The CLAS survey will be a self-
has provided direct patient care, American Medical Association or the administered online questionnaire, with
training related to cultural competency American Osteopathic Association as paper form and telephone
and the National CLAS Standards, providing ‘‘office-based, patient care.’’ administration as follow-up alternatives
provision of CLAS to patients, The target universe excludes physicians for non-respondents. A three-year
organizational characteristics that in the specialties of anesthesiology, approval will be requested.
helped or prevented provision of CLAS, radiology, and pathology. The survey There is no cost to the respondents
sample of 2,400 physicians will be used other than their time.
ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of
Number of burden per Total burden
Type of respondent Form name responses per
respondents response hours
respondent (in hours)
Office-based physicians .................... NAMCS CLAS Survey ..................... 800 1 30/60 400
Total ........................................... ........................................................... ........................ ........................ ........................ 400
Leroy A. Richardson, postpartum women who had recent or sponsor. In addition, the PRA also
Chief, Information Collection Review Office, Gestational diabetes mellitus (GDM). requires Federal agencies to provide a
Office of Scientific Integrity, Office of the DATES: Written comments must be 60-day notice in the Federal Register
Associate Director for Science, Office of the received on or before October 27, 2015. concerning each proposed collection of
Director, Centers for Disease Control and information, including each new
ADDRESSES: You may submit comments,
Prevention.
identified by Docket No. CDC–2015– proposed collection, each proposed
[FR Doc. 2015–21343 Filed 8–27–15; 8:45 am] extension of existing collection of
0071 by any of the following methods:
BILLING CODE 4163–18–P
Federal eRulemaking Portal: information, and each reinstatement of
Regulation.gov. Follow the instructions previously approved information
for submitting comments. collection before submitting the
DEPARTMENT OF HEALTH AND Mail: Leroy A. Richardson, collection to OMB for approval. To
HUMAN SERVICES Information Collection Review Office, comply with this requirement, we are
Centers for Disease Control and Centers for Disease Control and publishing this notice of a proposed
Prevention Prevention, 1600 Clifton Road NE., MS– data collection as described below.
D74, Atlanta, Georgia 30329. Comments are invited on: (a) Whether
[60Day–15–15BEB; Docket No. CDC–2015– Instructions: All submissions received the proposed collection of information
0071] must include the agency name and is necessary for the proper performance
Docket Number. All relevant comments
of the functions of the agency, including
Proposed Data Collection Submitted received will be posted without change
whether the information shall have
for Public Comment and to Regulations.gov, including any
practical utility; (b) the accuracy of the
Recommendations personal information provided. For
agency’s estimate of the burden of the
access to the docket to read background
AGENCY: Centers for Disease Control and proposed collection of information; (c)
documents or comments received, go to
Prevention (CDC), Department of Health ways to enhance the quality, utility, and
Regulations.gov.
and Human Services (HHS). clarity of the information to be
Please note: All public comment should be collected; (d) ways to minimize the
ACTION: Notice with comment period. submitted through the Federal eRulemaking burden of the collection of information
portal (Regulations.gov) or by U.S. mail to the
SUMMARY: The Centers for Disease address listed above.
on respondents, including through the
Control and Prevention (CDC), as part of use of automated collection techniques
its continuing efforts to reduce public FOR FURTHER INFORMATION CONTACT: To or other forms of information
burden and maximize the utility of request more information on the technology; and (e) estimates of capital
government information, invites the proposed project or to obtain a copy of or start-up costs and costs of operation,
general public and other Federal the information collection plan and maintenance, and purchase of services
agencies to take this opportunity to instruments, contact the Information to provide information. Burden means
comment on proposed and/or Collection Review Office, Centers for the total time, effort, or financial
continuing information collections, as Disease Control and Prevention, 1600 resources expended by persons to
required by the Paperwork Reduction Clifton Road NE., MS–D74, Atlanta, generate, maintain, retain, disclose or
Act of 1995. This notice invites Georgia 30329; phone: 404–639–7570; provide information to or for a Federal
Lhorne on DSK5TPTVN1PROD with NOTICES
comment on a proposed information Email: omb@cdc.gov. agency. This includes the time needed
collect project entitled Balance After SUPPLEMENTARY INFORMATION: Under the to review instructions; to develop,
Baby Intervention: Phase 2 (BABI2.) A Paperwork Reduction Act of 1995 (PRA) acquire, install and utilize technology
three-year clearance is requested to (44 U.S.C. 3501–3520), Federal agencies and systems for the purpose of
conduct a randomized controlled trial of must obtain approval from the Office of collecting, validating and verifying
a Web site-based lifestyle program with Management and Budget (OMB) for each information, processing and
a racially diverse population of collection of information they conduct maintaining information, and disclosing
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![52294 Federal Register / Vol. 80, No. 167 / Friday, August 28, 2015 / Notices
Leroy A. Richardson, SUPPLEMENTARY INFORMATION: • Jacqueline Phillips* (February
Chief, Information Collection Review Office, 2016)
Office of Scientific Integrity, Office of the I. Background • Johnathan Pregler, M.D.
Associate Director for Science, Office of the The Secretary of the Department of • Traci Rabine* (January 2016)
Director, Centers for Disease Control and Health and Human Services (the • Michael Rabovsky, M.D.
Prevention. Secretary) is required by section • Wendy Resnick, F.H.F.M.A.
[FR Doc. 2015–21344 Filed 8–27–15; 8:45 am] 1833(t)(9)(A) of the Social Security Act • Michael K. Schroyer, R.N.
BILLING CODE 4163–18–P (the Act), and section 222 of the Public • Marianna V. Spanaki-Varelas M.D.,
Health Service Act (PHS Act) to consult Ph.D., M.B.A.* (February 2016)
with an expert outside advisory panel • Norman Thomson, III, M.D.
DEPARTMENT OF HEALTH AND regarding the clinical integrity of the • Gale Walker* (January 2016)
HUMAN SERVICES • Kris Zimmer
Ambulatory Payment Classification
Panel members serve on a voluntary
(APC) groups and relative payment
Centers for Medicare & Medicaid basis, without compensation, according
weights that are components of the
Services to an advance written agreement;
Medicare Hospital Outpatient
however, for the meetings, CMS
[CMS–1643–N] Prospective Payment System (OPPS),
reimburses travel, meals, lodging, and
and the appropriate supervision level
Medicare Program; Solicitation of related expenses in accordance with
for hospital therapeutic outpatient
Nominations to the Advisory Panel on standard Government travel regulations.
services. The Advisory Panel on
Hospital Outpatient Payment CMS has a special interest in ensuring,
Hospital Outpatient Payment (HOP, the
while taking into account the nominee
AGENCY: Centers for Medicare & Panel) is governed by the provisions of
pool, that the Panel is diverse in all
Medicaid Services (CMS), HHS. the Federal Advisory Committee Act
respects of the following: Geography;
ACTION: Notice.
(FACA) (Pub. L. 92–463), as amended (5
rural or urban practice; race, ethnicity,
U.S.C. Appendix 2), which sets forth
sex, and disability; medical or technical
SUMMARY: This notice solicits standards for the formation and use of
specialty; and type of hospital, hospital
nominations for up to seven new advisory panels. The Panel may
health system, or other Medicare
members to the Advisory Panel on consider data collected or developed by
provider subject to the OPPS.
Hospital Outpatient Payment (HOP, the entities and organizations (other than Based upon either self-nominations or
Panel). There will be vacancies on the the Department of Health and Human nominations submitted by providers or
Panel for four-year terms that begin Services) as part of their deliberations. interested organizations, the Secretary,
during Calendar Year 2016. The Charter provides that the Panel or her designee, appoints new members
The purpose of the Panel is to advise shall meet up to 3 times annually. We to the Panel from among those
the Secretary of the Department of consider the technical advice provided candidates determined to have the
Health and Human Services (Secretary) by the Panel as we prepare the proposed required expertise. New appointments
and the Administrator of the Centers for and final rules to update the OPPS for are made in a manner that ensures a
Medicare & Medicaid Services on the the following Calendar Year (CY). balanced membership under the FACA
clinical integrity of the Ambulatory The Panel shall consist of a chair and guidelines. For 2016, we anticipate
Payment Classification groups and their up to 15 members who are full-time doing one solicitation for nominees. Our
associated weights, and supervision of employees of hospitals, hospital appointment schedule will assure that
hospital outpatient therapeutic services. systems, or other Medicare providers we have the full complement of
The Secretary re-chartered the Panel that are subject to the OPPS. For members for each Panel meeting.
in 2014 for a 2-year period effective supervision deliberations, the Panel Current members’ terms expire at
through November 6, 2016. shall also include members that different times throughout the year;
DATES: Submission of Nominations: We represent the interests of Critical Access therefore, we will add new members
will consider nominations if they are Hospitals (CAHs), who advise the throughout the year as terms expire.
received no later than 5 p.m. Eastern Centers for Medicare & Medicaid
Standard Time (E.S.T) October 27, 2015. Services (CMS) only regarding the level II. Criteria for Nominees
ADDRESSES: Please submit nominations of supervision for hospital outpatient The Panel must be fairly balanced in
electronically to the following email therapeutic services. (For purposes of its membership in terms of the points of
address: APCPanel@cms.hhs.gov. the Panel, consultants or independent view represented and the functions to
Web site: For additional information contractors are not considered to be full- be performed. Each panel member must
on the Panel and updates to the Panel’s time employees in these organizations.) be employed full-time by a hospital,
activities, we refer readers to our Web The current Panel members are as hospital system, or other Medicare
site at the following address: http:// follows: provider subject to payment under the
www.cms.gov/Regulations-and- (Note: The asterisk [*] indicates the OPPS (except for the CAH members,
Guidance/Guidance/FACA/Advisory Panel members whose terms end during since CAHs are not paid under the
PanelonAmbulatoryPayment CY 2016, along with the month that the OPPS). All members must have
ClassificationGroups.html. term ends.) technical expertise to enable them to
FOR FURTHER INFORMATION CONTACT: • E.L. Hambrick, M.D., J.D., Chair, a participate fully in the Panel’s work.
Persons wishing to nominate CMS Medical Officer. Such expertise encompasses hospital
individuals to serve on the Panel or to • Karen Borman, M.D., F.A.C.S.* payment systems; hospital medical care
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obtain further information may contact (July 2016) delivery systems; provider billing
Carol Schwartz at the following email • Dawn L. Francis, M.D., M.H.S. systems; APC groups; Current
address: APCPanel@cms.hhs.gov or call • Ruth Lande Procedural Terminology codes; and
(410) 786–3985. • Jim Nelson, M.B.A., C.P.A., alpha-numeric Health Care Common
News Media: Representatives should F.H.F.M.A.* (January 2016) Procedure Coding System codes; and
contact the CMS Press Office at (202) • Leah Osbahr, M.A., M.P.H.* the use of, and payment for, drugs,
690–6145. (January 2016) medical devices, and other services in
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Document Created: 2015-12-15 11:05:08
Document Modified: 2015-12-15 11:05:08
| 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 | Written comments must be received on or before October 27, 2015. | |
| Contact | To request more information on the proposed project or to obtain a copy of the information collection plan and instruments, contact the 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 | 80 FR 52292 |
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