80 FR 73769 - Agency Forms Undergoing Paperwork Reduction Act Review
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention Federal Register Volume 80, Issue 227 (November 25, 2015)
Centers for Disease Control and Prevention
Federal Register Volume 80, Issue 227 (November 25, 2015)
| Page Range | 73769-73770 | |
| FR Document | 2015-30061 |
[Federal Register Volume 80, Number 227 (Wednesday, November 25, 2015)] [Notices] [Pages 73769-73770] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-30061] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30Day-16-15AUJ] 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 Paul Coverdell National Acute Stroke Program (PCNASP)--New-- National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), Centers for Disease Control and Prevention (CDC). Background and Brief Description Stroke is the fifth leading cause of death in the United States and results in approximately 130,000 deaths per year. Stroke outcomes depend upon the rapid recognition of signs and symptoms of stroke, prompt transport to a treatment facility, and early rehabilitation. Improving outcomes requires a coordinated systems approach involving pre-hospital care, emergency department and hospital care, rehabilitation, prevention of complications, and ongoing secondary prevention. Through the Paul Coverdell National Acute Stroke Program (PCNASP), CDC has been continuously working to measure and improve acute stroke care using well-known quality improvement strategies coupled with frequent evaluation of results. PCNASP awardees are state health departments who work with participating hospitals and EMS agencies in their jurisdictions to improve quality of care for stroke patients. Nine awardees were funded under five-year cooperative agreements effective July 1, 2015. Awardees and their selected hospital partners will systematically collect and report data on stroke care data across the continuum of care which includes pre-hospital (EMS), in-hospital, and post-hospital phases of care. In addition, PCNASP awardees will also request information from hospitals that admit and treat stroke patients in awardees' jurisdictions. This information is needed to understand the capacity and infrastructure of the systems for acute stroke care. Hospitals will transmit pre-hospital and post-hospital information to their awardee quarterly. The average burden per response is 15 minutes for pre-hospital and post-hospital information transmission. There is no burden for hospitals to transmit in-hospital data, because awardees use their own processes to extract in-hospital data from hospitals' electronic systems. Each hospital will collect and transmit hospital inventory information to its PCNASP awardee annually. This average burden per response is 30 minutes. The average burden per response for awardees to transmit pre- hospital, in-hospital, and post-hospital data to CDC will vary between 30-90 minutes. The burden will be 30 minutes each for independent submission of information relating to the pre-hospital, in-hospital, and post-hospital phases of patient care. Alternatively, the burden will be 90 minutes for awardees who transmit pre-, in-, and post- hospital data as one [[Page 73770]] combined file. CDC accepts file transmissions as individual phases or combined. In addition, each PCNASP awardee will prepare an annual aggregate hospital inventory file for transmission to CDC. The average burden of reporting hospital inventory information for each PCNASP awardee is eight hours per response. All patient, hospital, and EMS provider data that is submitted to CDC by PCNASP awardees will be de-identified and occur through secure data systems. Proposed data elements and quality indicators may be updated over time to include new or revised items based on evolving recommendations and standards in the field to improve the quality of stroke care. OMB approval is requested for three years. Participation is voluntary and there are no costs to respondents other than their time. The total estimated annualized burden hours are 382. Estimated Annualized Burden Hours ---------------------------------------------------------------------------------------------------------------- Number of Average burden Type of respondent Form name Number of responses per per response respondents respondent (in hours) ---------------------------------------------------------------------------------------------------------------- PCNASP Hospital Partners.............. Pre-hospital quality of 78 4 15/60 care data. Post-hospital quality of 20 4 15/60 care data. Hospital inventory data. 315 1 30/60 PCNASP Awardee........................ Pre-hospital quality of 9 4 30/60 care data. In-hospital quality of 9 4 30/60 care data. Post-hospital quality of 9 4 30/60 care data. Hospital inventory data. 9 1 8 ---------------------------------------------------------------------------------------------------------------- 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. 2015-30061 Filed 11-24-15; 8:45 am] BILLING CODE 4163-18-P
![Federal Register / Vol. 80, No. 227 / Wednesday, November 25, 2015 / Notices 73769
support of DGHP country offices. DEPARTMENT OF HEALTH AND Background and Brief Description
Specifically, it: (1) Coordinates all HUMAN SERVICES Stroke is the fifth leading cause of
DGHP procurement and extramural death in the United States and results in
activities in compliance with federal Centers for Disease Control and
approximately 130,000 deaths per year.
appropriations law, congressional Prevention
Stroke outcomes depend upon the rapid
intent, and global health policies; (2) recognition of signs and symptoms of
facilitates and manages the [30Day–16–15AUJ]
stroke, prompt transport to a treatment
development, clearance, and award of Agency Forms Undergoing Paperwork facility, and early rehabilitation.
all new and ongoing DGHP field grants, Reduction Act Review Improving outcomes requires a
cooperative agreements, and contracts; coordinated systems approach involving
(3) provides technical assistance and The Centers for Disease Control and pre-hospital care, emergency
guidance to country offices and DGHP Prevention (CDC) has submitted the department and hospital care,
branches on budget and extramural following information collection request rehabilitation, prevention of
issues including assisting programs in to the Office of Management and Budget complications, and ongoing secondary
determining the appropriate funding (OMB) for review and approval in prevention.
mechanism to support DGHP activities; accordance with the Paperwork Through the Paul Coverdell National
(4) provides training and tools to DGHP Reduction Act of 1995. The notice for Acute Stroke Program (PCNASP), CDC
country programs to improve budget the proposed information collection is has been continuously working to
and cooperative agreement published to obtain comments from the measure and improve acute stroke care
public and affected agencies. using well-known quality improvement
management; (5) manages DGHP
Written comments and suggestions strategies coupled with frequent
country budgets including conducting
from the public and affected agencies evaluation of results. PCNASP awardees
budget planning exercises, spend plan
concerning the proposed collection of are state health departments who work
development and reporting, annual information are encouraged. Your with participating hospitals and EMS
close-out processes, and analyses to comments should address any of the agencies in their jurisdictions to
inform country planning; (6) provides following: (a) Evaluate whether the improve quality of care for stroke
funding and budgetary data for regular proposed collection of information is patients.
reports including HHS and OMB necessary for the proper performance of Nine awardees were funded under
reports, GAO and IG audits, country the functions of the agency, including five-year cooperative agreements
program reviews, and other requests for whether the information will have effective July 1, 2015. Awardees and
data; (7) liaises and collaborates with practical utility; (b) Evaluate the their selected hospital partners will
CDC financial and procurement-related accuracy of the agencies estimate of the systematically collect and report data on
units and offices including OFR and the burden of the proposed collection of stroke care data across the continuum of
Information Technology Services Office; information, including the validity of care which includes pre-hospital (EMS),
(8) collaborates with other DGHP the methodology and assumptions used; in-hospital, and post-hospital phases of
branches, other CDC and HHS programs (c) Enhance the quality, utility, and care. In addition, PCNASP awardees
and offices, other USG agencies, and clarity of the information to be will also request information from
other national and international collected; (d) Minimize the burden of hospitals that admit and treat stroke
organizations on overseas management the collection of information on those patients in awardees’ jurisdictions. This
and operations priorities; (9) develops who are to respond, including through information is needed to understand the
strategies to improve the technical skills the use of appropriate automated, capacity and infrastructure of the
and problem-solving abilities of country electronic, mechanical, or other systems for acute stroke care.
program managers and locally employed technological collection techniques or Hospitals will transmit pre-hospital
other forms of information technology, and post-hospital information to their
staff who work in the budget and
e.g., permitting electronic submission of awardee quarterly. The average burden
finance area; (10) provides short-term
responses; and (e) Assess information per response is 15 minutes for pre-
and long-term consultation and
collection costs. hospital and post-hospital information
technical assistance for management transmission. There is no burden for
To request additional information on
and operations issues to DGHP country the proposed project or to obtain a copy hospitals to transmit in-hospital data,
offices; (11) facilitates overseas of the information collection plan and because awardees use their own
purchasing and property management instruments, call (404) 639–7570 or processes to extract in-hospital data
activities; (12) monitors risk send an email to omb@cdc.gov. Written from hospitals’ electronic systems. Each
management of country operations and comments and/or suggestions regarding hospital will collect and transmit
extramural awards; (13) oversees the items contained in this notice hospital inventory information to its
property, facilities, motor pool, and should be directed to the Attention: PCNASP awardee annually. This
records management; and (14) CDC Desk Officer, Office of Management average burden per response is 30
coordinates other logistics needs for and Budget, Washington, DC 20503 or minutes.
DGHP overseas operations. by fax to (202) 395–5806. Written The average burden per response for
comments should be received within 30 awardees to transmit pre-hospital, in-
James Seligman,
days of this notice. hospital, and post-hospital data to CDC
Acting Chief Operating Officer, Centers for will vary between 30–90 minutes. The
Disease Control and Prevention. Proposed Project
tkelley on DSK3SPTVN1PROD with NOTICES
burden will be 30 minutes each for
[FR Doc. 2015–29914 Filed 11–24–15; 8:45 am] Paul Coverdell National Acute Stroke independent submission of information
BILLING CODE 4160–18–P Program (PCNASP)—New—National relating to the pre-hospital, in-hospital,
Center for Chronic Disease Prevention and post-hospital phases of patient care.
and Health Promotion (NCCDPHP), Alternatively, the burden will be 90
Centers for Disease Control and minutes for awardees who transmit
Prevention (CDC). pre-, in-, and post-hospital data as one
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![73770 Federal Register / Vol. 80, No. 227 / Wednesday, November 25, 2015 / Notices
combined file. CDC accepts file information for each PCNASP awardee based on evolving recommendations
transmissions as individual phases or is eight hours per response. and standards in the field to improve
combined. In addition, each PCNASP All patient, hospital, and EMS the quality of stroke care.
awardee will prepare an annual provider data that is submitted to CDC
OMB approval is requested for three
aggregate hospital inventory file for by PCNASP awardees will be de-
identified and occur through secure data years. Participation is voluntary and
transmission to CDC. The average there are no costs to respondents other
burden of reporting hospital inventory systems. Proposed data elements and
quality indicators may be updated over than their time. The total estimated
time to include new or revised items annualized burden hours are 382.
ESTIMATED ANNUALIZED BURDEN HOURS
Average bur-
Number of re-
Number of den per re-
Type of respondent Form name sponses per
respondents sponse
respondent (in hours)
PCNASP Hospital Partners ............................ Pre-hospital quality of care data .................... 78 4 15/60
Post-hospital quality of care data .................. 20 4 15/60
Hospital inventory data .................................. 315 1 30/60
PCNASP Awardee .......................................... Pre-hospital quality of care data .................... 9 4 30/60
In-hospital quality of care data ....................... 9 4 30/60
Post-hospital quality of care data .................. 9 4 30/60
Hospital inventory data .................................. 9 1 8
Leroy A. Richardson, and 325 mg/60 mg, if all other legal and A person may petition the Agency to
Chief, Information Collection Review Office, regulatory requirements are met. determine, or the Agency may
Office of Scientific Integrity, Office of the FOR FURTHER INFORMATION CONTACT: Jane determine on its own initiative, whether
Associate Director for Science, Office of the Baluss, Center for Drug Evaluation and a listed drug was withdrawn from sale
Director, Centers for Disease Control and for reasons of safety or effectiveness.
Research, Food and Drug
Prevention.
Administration, 10903 New Hampshire This determination may be made at any
[FR Doc. 2015–30061 Filed 11–24–15; 8:45 am] time after the drug has been withdrawn
Ave., Bldg. 51, Rm. 6278, Silver Spring,
BILLING CODE 4163–18–P from sale, but must be made prior to
MD 20993–0002, 301–796–3469.
SUPPLEMENTARY INFORMATION: In 1984, approving an ANDA that refers to the
Congress enacted the Drug Price listed drug (§ 314.161 (21 CFR 314.161)).
DEPARTMENT OF HEALTH AND FDA may not approve an ANDA that
HUMAN SERVICES Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98–417) does not refer to a listed drug.
Food and Drug Administration (the 1984 amendments), which TYLENOL WITH CODEINE
authorized the approval of duplicate (acetaminophen with codeine
[Docket No. FDA–2015–P–1153] versions of drug products under an phosphate) oral tablets, 325 mg/7.5 mg,
Determination That TYLENOL WITH ANDA procedure. ANDA applicants 325 mg/15 mg, 325 mg/30 mg, and 325
CODEINE (Acetaminophen With must, with certain exceptions, show that mg/60 mg, are the subject of ANDA 85–
the drug for which they are seeking 056 held by McNeil Ortho
Codeine Phosphate) Oral Tablets, 325
approval contains the same active Pharmaceuticals, Inc., and were initially
Milligrams/7.5 Milligrams, 325
ingredient in the same strength and approved July 9, 1976. TYLENOL WITH
Milligrams/15 Milligrams, 325
dosage form as the ‘‘listed drug,’’ which CODEINE is indicated for the relief of
Milligrams/30 Milligrams, and 325
is a version of the drug that was mild to moderately severe pain.
Milligrams/60 Milligrams, Were Not
previously approved. ANDA applicants
Withdrawn From Sale for Reasons of In a letter dated January 26, 1993,
do not have to repeat the extensive
Safety or Effectiveness McNeil Ortho Pharmaceuticals, Inc.
clinical testing otherwise necessary to
notified FDA that TYLENOL WITH
AGENCY: Food and Drug Administration, gain approval of a new drug application
CODEINE (acetaminophen with codeine
HHS. (NDA).
The 1984 amendments include what phosphate) oral tablets, 325 mg/7.5 mg,
ACTION: Notice. 325 mg/15 mg, 325 mg/30 mg, and 325
is now section 505(j)(7) of the Federal
SUMMARY: The Food and Drug Food, Drug, and Cosmetic Act (21 U.S.C. mg/60 mg, were being discontinued,
Administration (FDA or Agency) has 355(j)(7)), which requires FDA to and FDA moved the drug product to the
determined that TYLENOL WITH publish a list of all approved drugs. ‘‘Discontinued Drug Product List’’
CODEINE (acetaminophen with codeine FDA publishes this list as part of the section of the Orange Book.
phosphate) oral tablets, 325 milligrams ‘‘Approved Drug Products With Lachman Consultant Services, Inc.
(mg)/7.5 mg, 325 mg/15 mg, 325 mg/30 Therapeutic Equivalence Evaluations,’’ submitted a citizen petition dated April
mg, and 325 mg/60 mg, were not which is known generally as the 7, 2015 (Docket No. FDA–2015–P–
withdrawn from sale for reasons of ‘‘Orange Book.’’ Under FDA regulations, 1153), under 21 CFR 10.30, requesting
tkelley on DSK3SPTVN1PROD with NOTICES
safety or effectiveness. This drugs are removed from the list if the that the Agency determine whether
determination will allow FDA to Agency withdraws or suspends TYLENOL WITH CODEINE
approve abbreviated new drug approval of the drug’s NDA or ANDA (acetaminophen with codeine
applications (ANDAs) for TYLENOL for reasons of safety or effectiveness or phosphate) oral tablets, 325 mg/7.5 mg,
WITH CODEINE (acetaminophen with if FDA determines that the listed drug 325 mg/15 mg, 325 mg/30 mg, and 325
codeine phosphate) oral tablets, 325 mg/ was withdrawn from sale for reasons of mg/60 mg, were withdrawn from sale
7.5 mg, 325 mg/15 mg, 325 mg/30 mg, safety or effectiveness (21 CFR 314.162). for reasons of safety or effectiveness.
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Document Created: 2018-03-01 11:15:13
Document Modified: 2018-03-01 11:15:13
| 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 73769 |
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