Proposed Information Collection Activity; Comment Request, 15751-15752 [06-2997]
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15751
Federal Register / Vol. 71, No. 60 / Wednesday, March 29, 2006 / Notices
Romania, Russia, Turkey, and Ukraine
on December 29, 2005; Nigeria on
February 8, 2006; India on February 22,
2006; Egypt on February 27, 2006; Niger
on March 2, 2006; Albania, Azerbaijan,
Cameroon, and Burma (Myanmar) on
March 15, 2006; and Israel on March 20,
2006.
On March 15, 2006, OIE reported
confirmation of highly pathogenic avian
influenza H5N1 in poultry in
Afghanistan. At this time, HHS/CDC is
adding Afghanistan to its current
embargo. This action is effective on
March 21, 2006, and will remain in
effect until further notice.
SUPPLEMENTARY INFORMATION:
Dated: March 23, 2006.
Julie Louise Gerberding,
Director, Centers for Disease Control and
Prevention, U.S. Department of Health and
Human Services.
[FR Doc. E6–4514 Filed 3–28–06; 8:45 am]
Background
On March 15, 2006, OIE reported
confirmation of highly pathogenic avian
influenza H5N1 in chickens and turkeys
in five provinces of Afghanistan,
including Jalalabad, Kabul, Laghman,
Vardak and Kunar.
Introduction of birds infected with
highly pathogenic avian influenza H5N1
into the United States could lead to
outbreaks of disease among birds and
among the human population, a
significant public health threat. Banning
the importation of all avian species from
affected countries is an effective means
of limiting this threat. HHS/CDC is
therefore taking this action to reduce the
likelihood of introduction or spread of
influenza A H5N1 into the United
States.
Proposed Projects
Title: Evaluation to Determine the
Effectiveness of the Public Assistance
Reporting Information System (PARIS).
OMB No. New Collection.
Description: The PARIS program is a
voluntary information exchange system
that allows States and other entities
(counties or jurisdictions like the
District of Columbia) to submit Medical
Assistance, Medicaid, Food Stamp, and
Temporary Assistance for Needy
Families (TANF) participant data to the
Administration for Children and
Families (ACF) to be matched with
Federal and participating States’
databases to detect potential dual
participation and improper payments.
Launched by ACF in 1997, the PARIS
project was developed to provide States
with usable data by which they could
identify and correct erroneous payments
and to promote State partnerships and
matching of cross-state data to improve
program integrity. There are currently
36 entities participating in the PARIS
project (Member States). ACF is
encouraging the expansion of PARIS via
a grantee program by providing funds to
Member States to partner with
nonparticipating States to develop the
internal organization and mechanisms
needed for PARIS participation. An
implementation and outcome evaluation
of the PARIS program will determine
the effectiveness of the program and the
Immediate Action
Therefore, pursuant to 42 CFR
71.32(b), HHS/CDC is amending the
February 4, 2004, order to add
Afghanistan to the list of countries
subject to the order’s embargo of birds
and products derived from birds. All
other portions of the February 4, 2004,
order, as further amended on March 10,
2004, September 28, 2004, December 29,
2005, February 8, 2006, February 22,
2006, February 27, 2006, March 2, 2006,
March 15, 2006, and March 20, 2006,
shall remain in effect until further
notice.
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Comment Request
resulting impact on reducing improper
payments. Data collected will determine
factors affecting program participation,
relevant PARIS administrative and
implementation information, challenges
in implementation, cost of program
participation and estimated savings
through identified and resolved
participant matches.
Health Systems Research, an ACF
Contractor conducting the research, will
send State-level PARIS Administrators
surveys regarding the organization and
administration of PARIS, processes used
for submitting data, and follow-up
protocols. Information obtained though
key-informant interviews of Medicaid,
TANF, and Food Stamp program
officials will provide information
regarding relationships among the
various stakeholders, opinions on
effectiveness of PARIS, and the rationale
behind decisions. E-mails sent to States
will contain cost-accounting forms,
providing cost information on program
start-up, submission of data, follow-up
of potential participant matches, and
will then be verified through telephone
interviews with program and fiscal
administrators. As part of the final
PARIS evaluation, a prospective and
retrospective analysis is planned.
Collections of prospective information
from a sample of States that are not yet
committed to permanent participation
in PARIS and prospective and
retrospective information from States
already participating in the program are
planned.
Two current PARIS sites and one nonPARIS grantee site will comprise a pilot
of the data collection instruments to
ensure evaluation questions are clear
and elicit salient responses. Findings
from the pilot study will inform the
final PARIS evaluation tool
development.
Respondents: Approximately sixteen
States will comprise the sample, with an
estimated twelve respondents from each
State, county or jurisdiction.
ANNUAL BURDEN ESTIMATES
Number of
respondents
hsrobinson on PROD1PC68 with NOTICES
Instrument
State-Level PARIS Administrator Survey ........................................................
Medicaid, Food Stamp and TANF Program Officials Key-Informant Interviews ............................................................................................................
State Cost-Accounting Forms ..........................................................................
Fiscal Administrator Telephone Interviews ......................................................
Estimated Total Annual Burden
Hours: 248.
VerDate Aug<31>2005
15:39 Mar 28, 2006
Jkt 208001
Frm 00061
Fmt 4703
Sfmt 4703
Average
burden hours
per response
Total burden
hours
16
1
1
16
160
16
32
1
1
1
1
1.5
1.5
160
24
48
In compliance with the requirements
of Section 3506(c)(2)(A) of the
PO 00000
Numer of
responses per
respondent
Paperwork Reduction Act of 1995, the
Administration for Children and
E:\FR\FM\29MRN1.SGM
29MRN1
15752
Federal Register / Vol. 71, No. 60 / Wednesday, March 29, 2006 / Notices
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Administration,
Office of Information Services, 370
L’Enfant Promenade, SW., Washington,
DC 20447, Attn: ACF Reports Clearance
Officer. E-mail address:
infocollection@acf.hhs.gov. All requests
should be identified by the title of the
information collection.
The Department specifically requests
comments 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)
the quality, utility, and clarity of the
information to be collected; and (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.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Dated: March 22, 2006.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 06–2997 Filed 3–28–06; 8:45am]
BILLING CODE 4184–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006N–0104]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Requirements for
Submission of Labeling for Human
Prescription Drugs and Biologics in
Electronic Format
AGENCY:
Food and Drug Administration,
HHS.
hsrobinson on PROD1PC68 with NOTICES
ACTION:
Notice.
SUMMARY: 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
VerDate Aug<31>2005
15:39 Mar 28, 2006
Jkt 208001
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 reporting requirements contained in
the requirements for submission of
labeling for human prescription drugs
and biologics in electronic format.
DATES: Submit written or electronic
comments on the collection of
information by May 30, 2006.
ADDRESSES: Submit electronic
comments on the collection of
information to: https://www.fda.gov/
dockets/ecomments. 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:
Karen Nelson, Office Management
Programs (HFA–250), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–1482.
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
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
PO 00000
Frm 00062
Fmt 4703
Sfmt 4703
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Requirements for Submission of
Labeling for Human Prescription Drugs
and Biologics in Electronic Format
(OMB Control Number 0910–0530)—
Extension
FDA is requesting that OMB extend
approval under the PRA for the
information collection contained in the
final rule entitled ‘‘Requirements for
Submission of Labeling for Human
Prescription Drugs and Biologics in
Electronic Format’’ (68 FR 69009,
December 11, 2003) (the final rule). The
final rule amended FDA regulations
governing the format in which certain
labeling is required to be submitted for
FDA review with new drug applications
(NDAs), certain biological license
applications (BLAs), abbreviated new
drug applications (ANDAs),
supplements, and annual reports. The
final rule required that the content of
labeling for prescription drug and
biological products required under 21
CFR 201.100(d)(3) be submitted to FDA
electronically in a form that FDA can
process, review, and archive. Copies of
product labeling have been required to
be submitted to FDA for review in
NDAs, certain BLAs, ANDAs, certain
supplements, and annual reports under
§§ 314.50, 314.70, 314.81, 314.94,
314.97, 314.98, 601.2, and 601.12 (21
CFR 314.50, 314.70, 314.81, 314.94,
314.97, 314.98, 601.2, and 601.12).
Under these regulations, copies of
labeling may be submitted electronically
or on paper. The final rule added the
requirement to submit the content of
labeling in electronic format to simplify
the drug labeling review process and
speed up the approval of labeling
changes.
The reporting burden for submitting
labeling under §§ 314.50, 314.70,
314.81, 314.94, 314.97, and 314.98 has
been estimated by FDA and the
collection of information has been
approved by OMB under OMB control
number 0910–0001, most recently until
May 31, 2008. The reporting burden
associated with current §§ 601.2 and
601.12 has also been estimated and that
collection of information has been
approved by OMB under OMB control
number 0910–0338, most recently until
September 30, 2008. We are not reestimating these approved burdens in
this action. Only the additional
reoccurring reporting burdens
associated with the electronic
submission of the content of labeling in
the final rule are estimated in this
action.
E:\FR\FM\29MRN1.SGM
29MRN1
]]>Agencies
[Federal Register Volume 71, Number 60 (Wednesday, March 29, 2006)]
[Notices]
[Pages 15751-15752]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 06-2997]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Proposed Information Collection Activity; Comment Request
Proposed Projects
Title: Evaluation to Determine the Effectiveness of the Public
Assistance Reporting Information System (PARIS).
OMB No. New Collection.
Description: The PARIS program is a voluntary information exchange
system that allows States and other entities (counties or jurisdictions
like the District of Columbia) to submit Medical Assistance, Medicaid,
Food Stamp, and Temporary Assistance for Needy Families (TANF)
participant data to the Administration for Children and Families (ACF)
to be matched with Federal and participating States' databases to
detect potential dual participation and improper payments. Launched by
ACF in 1997, the PARIS project was developed to provide States with
usable data by which they could identify and correct erroneous payments
and to promote State partnerships and matching of cross-state data to
improve program integrity. There are currently 36 entities
participating in the PARIS project (Member States). ACF is encouraging
the expansion of PARIS via a grantee program by providing funds to
Member States to partner with nonparticipating States to develop the
internal organization and mechanisms needed for PARIS participation. An
implementation and outcome evaluation of the PARIS program will
determine the effectiveness of the program and the resulting impact on
reducing improper payments. Data collected will determine factors
affecting program participation, relevant PARIS administrative and
implementation information, challenges in implementation, cost of
program participation and estimated savings through identified and
resolved participant matches.
Health Systems Research, an ACF Contractor conducting the research,
will send State-level PARIS Administrators surveys regarding the
organization and administration of PARIS, processes used for submitting
data, and follow-up protocols. Information obtained though key-
informant interviews of Medicaid, TANF, and Food Stamp program
officials will provide information regarding relationships among the
various stakeholders, opinions on effectiveness of PARIS, and the
rationale behind decisions. E-mails sent to States will contain cost-
accounting forms, providing cost information on program start-up,
submission of data, follow-up of potential participant matches, and
will then be verified through telephone interviews with program and
fiscal administrators. As part of the final PARIS evaluation, a
prospective and retrospective analysis is planned. Collections of
prospective information from a sample of States that are not yet
committed to permanent participation in PARIS and prospective and
retrospective information from States already participating in the
program are planned.
Two current PARIS sites and one non-PARIS grantee site will
comprise a pilot of the data collection instruments to ensure
evaluation questions are clear and elicit salient responses. Findings
from the pilot study will inform the final PARIS evaluation tool
development.
Respondents: Approximately sixteen States will comprise the sample,
with an estimated twelve respondents from each State, county or
jurisdiction.
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Numer of Average
Instrument Number of responses per burden hours Total burden
respondents respondent per response hours
----------------------------------------------------------------------------------------------------------------
State-Level PARIS Administrator Survey.......... 16 1 1 16
Medicaid, Food Stamp and TANF Program Officials 160 1 1 160
Key-Informant Interviews.......................
State Cost-Accounting Forms..................... 16 1 1.5 24
Fiscal Administrator Telephone Interviews....... 32 1 1.5 48
----------------------------------------------------------------------------------------------------------------
Estimated Total Annual Burden Hours: 248.
In compliance with the requirements of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the Administration for Children and
[[Page 15752]]
Families is soliciting public comment on the specific aspects of the
information collection described above. Copies of the proposed
collection of information can be obtained and comments may be forwarded
by writing to the Administration for Children and Families, Office of
Administration, Office of Information Services, 370 L'Enfant Promenade,
SW., Washington, DC 20447, Attn: ACF Reports Clearance Officer. E-mail
address: infocollection@acf.hhs.gov. All requests should be identified
by the title of the information collection.
The Department specifically requests comments 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) the quality, utility, and clarity of the information
to be collected; and (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.
Consideration will be given to comments and suggestions submitted
within 60 days of this publication.
Dated: March 22, 2006.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 06-2997 Filed 3-28-06; 8:45am]
BILLING CODE 4184-01-M
