Agency Forms Undergoing Paperwork Reduction Act Review, 69092-69093 [2013-27447]
Download as PDF
<![CDATA[
69092
Federal Register / Vol. 78, No. 222 / Monday, November 18, 2013 / Notices
LeRoy 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. 2013–27485 Filed 11–15–13; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–14–0728]
Agency Forms Undergoing Paperwork
Reduction Act Review
The Centers for Disease Control and
Prevention (CDC) publishes a list of
information collection requests under
review by the Office of Management and
Budget (OMB) in compliance with the
Paperwork Reduction Act (44 U.S.C.
Chapter 35). To request a copy of these
requests, call (404) 639–7570 or send an
email to omb@cdc.gov. Send written
comments to 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 Notifiable Disease
Surveillance System (NNDSS) [0920–
0728, Exp, Jan 31, 2014]—Revision—
Center for Surveillance, Epidemiology,
and Laboratory Services (CSELS),
Division of Health Informatics and
Surveillance (DHIS), Centers for Disease
Control and Prevention (CDC).
Background and Brief Description:
The Public Health Services Act (42
U.S.C. 241) authorizes CDC to
disseminate nationally notifiable
condition information. The Nationally
Notifiable Disease Surveillance System
(NNDSS) is based on data collected at
the state, territorial and local levels as
a result of legislation and regulations in
those jurisdictions that require health
care providers, medical laboratories,
and other entities to submit healthrelated data on reportable conditions to
public health departments. These
reportable conditions, which include
infectious and non-infectious diseases,
vary by jurisdiction depending upon
each jurisdiction’s health priorities and
needs. Currently approximately 300
conditions are reportable in one or more
of the states. Since infectious disease
agents and environmental hazards often
cross geographical boundaries, public
health departments have to be able to
share data on certain conditions across
jurisdictions and coordinate program
activities to prevent and control the
conditions. Each year, the Council of
State and Territorial Disease
Epidemiologists (CSTE), supported by
CDC, performs an assessment of
conditions reported to state, territorial
and local jurisdictions to determine
which should be designated nationally
notifiable conditions. For conditions
that are nationally notifiable, case
notifications are voluntarily submitted
to CDC so that information can be
shared across jurisdictional boundaries
and both surveillance and prevention
and control activities can be
coordinated at regional and national
levels.
CDC requests a three year approval for
a Revision of the National Notifiable
Diseases Surveillance System (NNDSS)
information collection, [National
Electronic Disease Surveillance System
(NEDSS, OMB Control No. 0920–0728,
Expiration Date 01/31/2014]. This
request has been developed in
coordination with four other CDC
applications to OMB for nationally
notifiable diseases case notification:
Control Numbers 0920–0128,
(Congenital Syphilis Surveillance),
0920–0819 (Nationally Notifiable
Sexually Transmitted Disease (STD)
Morbidity Surveillance) 0920–0009
(National Disease Surveillance
Program—I. Case Reports) and 0920–
0004 (National Disease Surveillance
Program—II. Disease Summaries). This
consolidation of information collection
0920–0128 and some parts of
information collections 0920–0819,
0920–0009 and 0920–0004, is an
important step in implementing CDC’s
longer term strategy of developing a
more coordinated and integrated
infectious diseases surveillance system
that reduces overlap and duplication;
increases interoperability, integration
and efficiency; and thereby reduces
burden to state, territorial and local
health departments that report
infectious disease data to CDC. Due to
the coordination, this NNDSS
application includes 11 conditions and
many additional data elements for the
case notifications that were not
previously included in NNDSS OMB
application Control No. 0920–0728. For
many conditions submitted to CDC,
participating public health departments
also submit data elements which are
specific to each condition. With the
coordination with other CDC programs
conducting surveillance on notifiable
conditions, this application includes
disease-specific tables for 68 diseases.
The 2010 NNDSS OMB application
included disease-specific data elements
for only 14 of those conditions.
Because this information collection
request includes case notifications that
were not part of the 2010 NNDSS/
NEDSS application, replaces one
application and replaces parts of three
other OMB applications, burden
estimates have been adjusted to
incorporate burden estimates from the
other four applications. The estimates
are adjusted for the increased number of
conditions reported to NNDSS, the
expansion of core data elements, and
the inclusion of more disease-specific
tables. These changes have increased
the burden estimates in this application
in comparison with the burden
estimates in the 2010 NNDSS/NEDSS
OMB application (OMB Control No.
0920–0728). As CDC works with state,
territorial and local health departments
to develop and implement new
information technologies to submit
these data through NNDSS, burden will
also increase as the public health
departments commit resources to
implementing the new technologies.
However, over the next 3 years, as the
new automated electronic systems are
implemented, burden will be decreased.
There are no costs to respondents other
than their time. The estimated annual
burden is 28,340 hours.
mstockstill on DSK4VPTVN1PROD with NOTICES
ESTIMATES OF ANNUALIZED BURDEN HOURS
Number of
respondents
Respondents
States ...........................................................................................................................................
Territories .....................................................................................................................................
Cities ............................................................................................................................................
VerDate Mar<15>2010
17:33 Nov 15, 2013
Jkt 232001
PO 00000
Frm 00053
Fmt 4703
Sfmt 4703
E:\FR\FM\18NON1.SGM
50
5
2
18NON1
Number of
responses per
respondent
52
52
52
Average
burden per
response
(in hours)
10
5
10
Federal Register / Vol. 78, No. 222 / Monday, November 18, 2013 / Notices
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.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2013–27447 Filed 11–15–13; 8:45 am]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Guidance for
Industry on Special Protocol
Assessment
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
ACTION:
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice.
AGENCY:
The Centers for Disease
Control and Prevention (CDC) located
within the Department of Health and
Human Services (HHS) is publishing the
names of the Performance Review Board
Members who are reviewing
performance for Fiscal Year 2013.
FOR FURTHER INFORMATION CONTACT:
Sharon O’Brien, Deputy Director,
Executive and Scientific Resources
Office, Human Capital and Resources
Management Office, Centers for Disease
Control and Prevention, 4770 Buford
Highway NE., Mailstop K–15, Atlanta,
Georgia 30341, Telephone (770) 488–
1781.
SUPPLEMENTARY INFORMATION: Title 5,
U.S.C. 4314(c)(4) of the Civil Service
Reform Act of 1978, Public Law 95–454,
requires that the appointment of
Performance Review Board Members be
published in the Federal Register. The
following persons will serve on the CDC
Performance Review Boards or Panels,
which will oversee the evaluation of
performance appraisals of Senior
Executive Service members for the
Fiscal Year 2013 review period:
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
Christine Branche, Co-Chair
James Seligman, Co-Chair
Barbara Bowman
Janet Collins
Hazel Dean
Jane Gentleman
Joseph Henderson
Jennifer Parker
Tanja Popovic
Steve Redd
Tom Sinks
Kevin Smagh
Dated: November 8, 2013.
Stacey Hoffman,
Acting Director, Division of Executive
Secretariat, Centers for Disease Control and
Prevention.
VerDate Mar<15>2010
17:33 Nov 15, 2013
Jkt 232001
Food and Drug Administration,
HHS.
Performance Review Board Members
BILLING CODE 4163–18–P
[Docket No. FDA–2013–N–1394]
AGENCY:
Centers for Disease Control and
Prevention
[FR Doc. 2013–27501 Filed 11–15–13; 8:45 am]
Food and Drug Administration
Notice.
The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the Agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal Agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
the information collection in the
guidance for industry on special
protocol assessment.
DATES: Submit either electronic or
written comments on the collection of
information by January 17, 2014.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 1350 Piccard
Dr., PI50–400B, Rockville, MD 20850,
PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
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.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
SUMMARY:
PO 00000
Frm 00054
Fmt 4703
Sfmt 4703
69093
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Guidance for Industry on Special
Protocol Assessment—(OMB Control
Number 0910–0470)—Extension
The ‘‘Guidance for Industry on
Special Protocol Assessment’’ describes
Agency procedures to evaluate issues
related to the adequacy (e.g., design,
conduct, analysis) of certain proposed
studies. The guidance describes
procedures for sponsors to request
special protocol assessment and for the
Agency to act on such requests. The
guidance provides information on how
the Agency interprets and applies
provisions of the Food and Drug
Administration Modernization Act of
1997 and the specific Prescription Drug
User Fee Act of 1992 (PDUFA) goals for
special protocol assessment associated
with the development and review of
PDUFA products. The guidance
describes the following two collections
of information: (1) The submission of a
notice of intent to request special
protocol assessment of a carcinogenicity
protocol and (2) the submission of a
request for special protocol assessment.
Notification for a Carcinogenicity
Protocol
As described in the guidance, a
sponsor interested in Agency
assessment of a carcinogenicity protocol
should notify the appropriate division
in FDA’s Center for Drug Evaluation and
Research (CDER) or the Center for
Biologics Evaluation and Research
(CBER) of an intent to request special
protocol assessment at least 30 days
E:\FR\FM\18NON1.SGM
18NON1
]]>Agencies
[Federal Register Volume 78, Number 222 (Monday, November 18, 2013)]
[Notices]
[Pages 69092-69093]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-27447]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-14-0728]
Agency Forms Undergoing Paperwork Reduction Act Review
The Centers for Disease Control and Prevention (CDC) publishes a
list of information collection requests under review by the Office of
Management and Budget (OMB) in compliance with the Paperwork Reduction
Act (44 U.S.C. Chapter 35). To request a copy of these requests, call
(404) 639-7570 or send an email to omb@cdc.gov. Send written comments
to 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 Notifiable Disease Surveillance System (NNDSS) [0920-0728,
Exp, Jan 31, 2014]--Revision--Center for Surveillance, Epidemiology,
and Laboratory Services (CSELS), Division of Health Informatics and
Surveillance (DHIS), Centers for Disease Control and Prevention (CDC).
Background and Brief Description: The Public Health Services Act
(42 U.S.C. 241) authorizes CDC to disseminate nationally notifiable
condition information. The Nationally Notifiable Disease Surveillance
System (NNDSS) is based on data collected at the state, territorial and
local levels as a result of legislation and regulations in those
jurisdictions that require health care providers, medical laboratories,
and other entities to submit health-related data on reportable
conditions to public health departments. These reportable conditions,
which include infectious and non-infectious diseases, vary by
jurisdiction depending upon each jurisdiction's health priorities and
needs. Currently approximately 300 conditions are reportable in one or
more of the states. Since infectious disease agents and environmental
hazards often cross geographical boundaries, public health departments
have to be able to share data on certain conditions across
jurisdictions and coordinate program activities to prevent and control
the conditions. Each year, the Council of State and Territorial Disease
Epidemiologists (CSTE), supported by CDC, performs an assessment of
conditions reported to state, territorial and local jurisdictions to
determine which should be designated nationally notifiable conditions.
For conditions that are nationally notifiable, case notifications are
voluntarily submitted to CDC so that information can be shared across
jurisdictional boundaries and both surveillance and prevention and
control activities can be coordinated at regional and national levels.
CDC requests a three year approval for a Revision of the National
Notifiable Diseases Surveillance System (NNDSS) information collection,
[National Electronic Disease Surveillance System (NEDSS, OMB Control
No. 0920-0728, Expiration Date 01/31/2014]. This request has been
developed in coordination with four other CDC applications to OMB for
nationally notifiable diseases case notification: Control Numbers 0920-
0128, (Congenital Syphilis Surveillance), 0920-0819 (Nationally
Notifiable Sexually Transmitted Disease (STD) Morbidity Surveillance)
0920-0009 (National Disease Surveillance Program--I. Case Reports) and
0920-0004 (National Disease Surveillance Program--II. Disease
Summaries). This consolidation of information collection 0920-0128 and
some parts of information collections 0920-0819, 0920-0009 and 0920-
0004, is an important step in implementing CDC's longer term strategy
of developing a more coordinated and integrated infectious diseases
surveillance system that reduces overlap and duplication; increases
interoperability, integration and efficiency; and thereby reduces
burden to state, territorial and local health departments that report
infectious disease data to CDC. Due to the coordination, this NNDSS
application includes 11 conditions and many additional data elements
for the case notifications that were not previously included in NNDSS
OMB application Control No. 0920-0728. For many conditions submitted to
CDC, participating public health departments also submit data elements
which are specific to each condition. With the coordination with other
CDC programs conducting surveillance on notifiable conditions, this
application includes disease-specific tables for 68 diseases. The 2010
NNDSS OMB application included disease-specific data elements for only
14 of those conditions.
Because this information collection request includes case
notifications that were not part of the 2010 NNDSS/NEDSS application,
replaces one application and replaces parts of three other OMB
applications, burden estimates have been adjusted to incorporate burden
estimates from the other four applications. The estimates are adjusted
for the increased number of conditions reported to NNDSS, the expansion
of core data elements, and the inclusion of more disease-specific
tables. These changes have increased the burden estimates in this
application in comparison with the burden estimates in the 2010 NNDSS/
NEDSS OMB application (OMB Control No. 0920-0728). As CDC works with
state, territorial and local health departments to develop and
implement new information technologies to submit these data through
NNDSS, burden will also increase as the public health departments
commit resources to implementing the new technologies. However, over
the next 3 years, as the new automated electronic systems are
implemented, burden will be decreased. There are no costs to
respondents other than their time. The estimated annual burden is
28,340 hours.
Estimates of Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of burden per
Respondents respondents responses per response (in
respondent hours)
----------------------------------------------------------------------------------------------------------------
States.......................................................... 50 52 10
Territories..................................................... 5 52 5
Cities.......................................................... 2 52 10
----------------------------------------------------------------------------------------------------------------
[[Page 69093]]
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. 2013-27447 Filed 11-15-13; 8:45 am]
BILLING CODE 4163-18-P
