80 FR 14140 - Agency Forms Undergoing Paperwork Reduction Act Review
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention Federal Register Volume 80, Issue 52 (March 18, 2015)
Centers for Disease Control and Prevention
Federal Register Volume 80, Issue 52 (March 18, 2015)
| Page Range | 14140-14141 | |
| FR Document | 2015-06159 |
[Federal Register Volume 80, Number 52 (Wednesday, March 18, 2015)] [Notices] [Pages 14140-14141] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-06159] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30Day-15-14AI0] 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 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]. Written comments and/or suggestions regarding the items contained in this notice should be directed 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 National Hospital Ambulatory Medical Care Survey (NHAMCS) Supplement of Primary Care Policies for Managing Patients with High Blood Pressure, High Cholesterol, or Diabetes (NSPCP)--New--National Center for Health Statistics (NCHS), Centers for Disease Control and Prevention (CDC). Background and Brief Description Cardiovascular disease is a leading cause of death and disability for men and women in the United States, among the most costly health problems facing our nation today, and among the most preventable. Risk factors for cardiovascular disease include high blood pressure and high cholesterol. Because over 50% of diabetics have high blood pressure, high cholesterol, or both conditions, the optimal systems to treat people with hypertension, high cholesterol, or diabetes are interrelated. In 2005, CDC's Division for Heart Disease and Stroke Prevention (DHDSP) began developing evaluation indicators that reflect evidence- based outcomes from policy, systems, and environmental changes related to heart disease and stroke prevention. However, many of the indicators for short-term policy and systems changes do not have readily available data sources. This is particularly true for outcomes related to health care systems changes. NCHS proposes to conduct a new information collection, the NSPCP. The survey will target primary care physicians specializing in internal medicine or family practice. Respondents will be drawn from a nationally representative sample of physicians. Physicians working in hospitals, federal facilities, nursing homes, rehabilitation centers and correctional facilities will not be eligible for the survey. Eligibility will be determined by phone. The survey instrument will undergo cognitive testing before administration. The telephone screener will be administered to the individual who answers the phone at the selected practice. We anticipate that this will likely be an office assistant or medical secretary. The primary purpose of the screener is to ensure correct contact information for the physician, so we anticipate that an office assistant or medical secretary will be able to answer the screener questions in a short amount of time. We have estimated 10 minutes per response. Administrators of the mail-based survey will collect information about physician practices' use of evidence-based systems, including multidisciplinary team approaches for chronic disease treatment, electronic health records (EHR) with features appropriate for treating patients with chronic disease (e.g., clinical decision supports, patient registries), and patient follow-up mechanisms. Approximately 946 physicians will participate in the [[Page 14141]] information collection. This is a one-time data collection effort. CDC will use the information to examine health systems and dissemination of health systems technology. Primary care practices will use the results to inform their systems for managing patients with chronic conditions and to improve the quality of care delivered. NCHS and CDC will also use the results to improve technical assistance to public health partners. OMB approval is requested for two years. Participation in the survey is voluntary and all responses CDC will de-identify all responses. There are no costs to respondents other than their time. The total estimated annualized burden hours are 429. Estimated Annualized Burden Hours ---------------------------------------------------------------------------------------------------------------- Average Number of Number burden per Type of respondent Form name respondents responses per response (in respondent hours) ---------------------------------------------------------------------------------------------------------------- Physician............................. Cognitive Testing 25 1 5/60 Screener. Physician............................. Cognitive Testing 15 1 1.25 Protocol. Medical Secretary..................... NSPCP Screener.......... 1,500 1 10/60 Physician............................. NSPCP................... 473 1 20/60 ---------------------------------------------------------------------------------------------------------------- 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. 2015-06159 Filed 3-17-15; 8:45 am] BILLING CODE 4163-18-P
![14140 Federal Register / Vol. 80, No. 52 / Wednesday, March 18, 2015 / Notices
announced in the Federal Register of DEPARTMENT OF HEALTH AND Health Statistics (NCHS), Centers for
February 27, 2015 (80 FR 10700). The HUMAN SERVICES Disease Control and Prevention (CDC).
amendment is being made to reflect a Background and Brief Description
change in the Agenda portion of the Centers for Disease Control and
document. There are no other changes. Prevention Cardiovascular disease is a leading
cause of death and disability for men
FOR FURTHER INFORMATION CONTACT: [30Day–15–14AI0] and women in the United States, among
Kristina Toliver, Center for Drug the most costly health problems facing
Evaluation and Research, Food and Agency Forms Undergoing Paperwork our nation today, and among the most
Drug Administration, 10903 New Reduction Act Review preventable. Risk factors for
Hampshire Ave., Bldg. 31, Rm. 2417, cardiovascular disease include high
The Centers for Disease Control and blood pressure and high cholesterol.
Silver Spring, MD 20993–0002, 301– Prevention (CDC) has submitted the
796–9001, FAX: 301–847–8533, Because over 50% of diabetics have
following information collection request high blood pressure, high cholesterol, or
CRDAC@fda.hhs.gov, or FDA Advisory to the Office of Management and Budget
Committee Information Line, 1–800– both conditions, the optimal systems to
(OMB) for review and approval in treat people with hypertension, high
741–8138 (301–443–0572 in the accordance with the Paperwork
Washington, DC area). Please call the cholesterol, or diabetes are interrelated.
Reduction Act of 1995. The notice for In 2005, CDC’s Division for Heart
Information Line for up-to-date the proposed information collection is Disease and Stroke Prevention (DHDSP)
information on this meeting. published to obtain comments from the began developing evaluation indicators
SUPPLEMENTARY INFORMATION: In the public and affected agencies. that reflect evidence-based outcomes
Federal Register of February 27, 2015, Written comments and suggestions from policy, systems, and
from the public and affected agencies environmental changes related to heart
FDA announced that a meeting of the
concerning the proposed collection of disease and stroke prevention. However,
Cardiovascular and Renal Drugs
information are encouraged. Your many of the indicators for short-term
Advisory Committee would be held on
comments should address any of the policy and systems changes do not have
April 15, 2015. On page 10700, in the following: (a) Evaluate whether the
first column, the Agenda portion of the readily available data sources. This is
proposed collection of information is particularly true for outcomes related to
document is changed to read as follows: necessary for the proper performance of health care systems changes.
The committee will discuss the new the functions of the agency, including NCHS proposes to conduct a new
drug application (NDA) 204958, whether the information will have information collection, the NSPCP. The
cangrelor injection, submitted by The practical utility; (b) Evaluate the survey will target primary care
Medicines Company, for the proposed accuracy of the agencies estimate of the physicians specializing in internal
indication of reduction of thrombotic burden of the proposed collection of medicine or family practice.
cardiovascular events in patients with information, including the validity of Respondents will be drawn from a
coronary artery disease (CAD) the methodology and assumptions used; nationally representative sample of
undergoing percutaneous coronary (c) Enhance the quality, utility, and physicians. Physicians working in
intervention (PCI)—(PCI refers to the clarity of the information to be hospitals, federal facilities, nursing
opening of narrowed blood vessels collected; (d) Minimize the burden of homes, rehabilitation centers and
supplying the heart muscle by a balloon the collection of information on those correctional facilities will not be eligible
inserted through an artery puncture who are to respond, including through for the survey. Eligibility will be
the use of appropriate automated, determined by phone.
with or without a stent) who have not
electronic, mechanical, or other The survey instrument will undergo
received an oral P2Y12 inhibitor prior to
technological collection techniques or cognitive testing before administration.
the PCI procedure and in whom oral other forms of information technology, The telephone screener will be
therapy with P2Y12 inhibitors is not e.g., permitting electronic submission of administered to the individual who
feasible or desirable (P2Y12 is a protein responses; and (e) Assess information answers the phone at the selected
involved in blood clotting. Inhibiting collection costs. practice. We anticipate that this will
this protein is a key mechanism of To request additional information on likely be an office assistant or medical
action of cangrelor). the proposed project or to obtain a copy secretary. The primary purpose of the
This notice is issued under the of the information collection plan and screener is to ensure correct contact
Federal Advisory Committee Act (5 instruments, call (404) 639–7570 or information for the physician, so we
U.S.C. app. 2) and 21 CFR part 14, send an email to omb@cdc.gov. Written anticipate that an office assistant or
relating to the advisory committees. comments and/or suggestions regarding medical secretary will be able to answer
the items contained in this notice the screener questions in a short amount
Dated: March 12, 2015.
should be directed to the Attention: of time. We have estimated 10 minutes
Leslie Kux, CDC Desk Officer, Office of Management per response.
Associate Commissioner for Policy. and Budget, Washington, DC 20503 or Administrators of the mail-based
[FR Doc. 2015–06130 Filed 3–17–15; 8:45 am] by fax to (202) 395–5806. Written survey will collect information about
BILLING CODE 4164–01–P comments should be received within 30 physician practices’ use of evidence-
days of this notice. based systems, including
mstockstill on DSK4VPTVN1PROD with NOTICES
multidisciplinary team approaches for
Proposed Project chronic disease treatment, electronic
National Hospital Ambulatory health records (EHR) with features
Medical Care Survey (NHAMCS) appropriate for treating patients with
Supplement of Primary Care Policies for chronic disease (e.g., clinical decision
Managing Patients with High Blood supports, patient registries), and patient
Pressure, High Cholesterol, or Diabetes follow-up mechanisms. Approximately
(NSPCP)—New—National Center for 946 physicians will participate in the
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![Federal Register / Vol. 80, No. 52 / Wednesday, March 18, 2015 / Notices 14141
information collection. This is a one- for managing patients with chronic voluntary and all responses CDC will
time data collection effort. conditions and to improve the quality of de-identify all responses. There are no
CDC will use the information to care delivered. NCHS and CDC will also costs to respondents other than their
examine health systems and use the results to improve technical time. The total estimated annualized
dissemination of health systems assistance to public health partners. burden hours are 429.
technology. Primary care practices will OMB approval is requested for two
use the results to inform their systems years. Participation in the survey is
ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number
Number of burden per
Type of respondent Form name responses per
respondents response
respondent (in hours)
Physician ......................................................... Cognitive Testing Screener ............................ 25 1 5/60
Physician ......................................................... Cognitive Testing Protocol ............................. 15 1 1.25
Medical Secretary ........................................... NSPCP Screener ........................................... 1,500 1 10/60
Physician ......................................................... NSPCP ........................................................... 473 1 20/60
Leroy A. Richardson, Arthritis & Musculoskeletal and Skin may be obtained by writing to the
Chief, Information Collection Review Office, Diseases, Building 10, Room 9N228, MSC indicated licensing contact at the Office
Office of Scientific Integrity, Office of the 1820, Bethesda, MD 20892, (301) 496–2612, of Technology Transfer, National
Associate Director for Science, Office of the osheaj@arb.niams.nih.gov. Institutes of Health, 6011 Executive
Director, Centers for Disease Control and Any interested person may file written Boulevard, Suite 325, Rockville,
Prevention. comments with the committee by forwarding Maryland 20852–3804; telephone: 301–
[FR Doc. 2015–06159 Filed 3–17–15; 8:45 am] the statement to the Contact Person listed on
this notice. The statement should include the
496–7057; fax: 301–402–0220. A signed
BILLING CODE 4163–18–P Confidential Disclosure Agreement will
name, address, telephone number and when
applicable, the business or professional be required to receive copies of the
affiliation of the interested person. patent applications.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES (Catalogue of Federal Domestic Assistance SUPPLEMENTARY INFORMATION:
Program Nos. 93.846, Arthritis, Technology descriptions follow.
National Institutes of Health Musculoskeletal and Skin Diseases Research,
National Institutes of Health, HHS). GTF2I Mutations as Genetic Marker for
National Institute of Arthritis and Dated: March 12, 2015.
Prognosis of Thymic Malignancies
Musculoskeletal and Skin Diseases; Carolyn Baum, Description of Technology: The
Notice of Closed Meeting Program Analyst, Office of Federal Advisory present invention describes the
Pursuant to section 10(d) of the Committee Policy. presence of a mutation in the general
Federal Advisory Committee Act, as [FR Doc. 2015–06122 Filed 3–17–15; 8:45 am] transcription factor IIi (GTF2I) gene in
amended (5 U.S.C. App.), notice is BILLING CODE 4140–01–P
indolent thymic tumors that is rarely
hereby given of a meeting of the Board found in more aggressive thymic
of Scientific Counselors, NIAMS. tumors.
The meeting will be closed to the DEPARTMENT OF HEALTH AND The invention provides a method of
public as indicated below in accordance HUMAN SERVICES determining the prognosis of thymic
with the provisions set forth in section cancer in a patient by assaying (for
552b(c)(6), Title 5 U.S.C., as amended National Institutes of Health example using PCR based methods) the
for the review, discussion, and genetic material obtained from the
Government-Owned Inventions; patient tissue to detect a mutation in at
evaluation of individual intramural Availability for Licensing
programs and projects conducted by the least one copy of GTF2I genetic
National Institute of Arthritis and AGENCY: National Institutes of Health, sequence; and correlating the presence
Musculoskeletal and Skin Diseases, HHS. of a GTF2I mutation with the prognosis
including consideration of personnel ACTION: Notice. of a thymic cancer patient, the presence
qualifications and performance, and the of the mutation indicating that the
competence of individual investigators, SUMMARY: The inventions listed below thymic cancer is indolent.
the disclosure of which would are owned by an agency of the U.S. A genetic test will complement the
constitute a clearly unwarranted Government and are available for diagnostic assessment, facilitate
invasion of personal privacy. licensing in the U.S. in accordance with development of a molecular
35 U.S.C. 209 and 37 CFR part 404 to classification and assessment for the
Name of Committee: Board of Scientific
Counselors, NIAMS. achieve expeditious commercialization clinical management of thymic cancers.
Date: April 15–16, 2015. of results of federally-funded research Potential Commercial Applications:
and development. Foreign patent • A diagnostic test kit for the
mstockstill on DSK4VPTVN1PROD with NOTICES
Time: 6:00 p.m. to 3:45 p.m.
Agenda: To review and evaluate personal applications are filed on selected prognosis and clinical management of
qualifications and performance, and inventions to extend market coverage thymic cancer.
competence of individual investigators. for companies and may also be available • Clinical decision whether treatment
Place: National Institutes of Health, for licensing.
Building 31, Room 4C32, 31 Center Drive,
is needed (for example, additional
Bethesda, MD 20892. FOR FURTHER INFORMATION CONTACT: treatment after surgery).
Contact Person: John J. O’Shea, MD, Ph.D., Licensing information and copies of the • Therapeutic decision making,
Scientific Director, National Institute of U.S. patent applications listed below between an aggressive course of
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Document Created: 2018-02-21 09:39:52
Document Modified: 2018-02-21 09:39:52
| 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 14140 |
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