Agency Information Collection Activities; Proposed Collection; Comment Request; Focus Groups as Used by the Food and Drug Administration, 71165-71167 [05-23248]
Download as PDF
<![CDATA[
Federal Register / Vol. 70, No. 226 / Friday, November 25, 2005 / Notices
finding and its reasons in the notice
issued.
We find it unnecessary to undertake
notice and comment rulemaking
because the statute and regulation
specify the methods of computation of
annual updates, and we have no
discretion in this matter. Further, this
notice does not change substantive
policy, but merely applies the update
methods specified in statute and
regulation. Therefore, for good cause,
we waive notice and comment
procedures.
Under the Congressional Review Act,
major rules generally cannot take effect
until 60 days after the rule is published
in the Federal Register. However,
section 808(2) of the Congressional
Review Act states that agencies may
waive this 60-day requirement for ‘‘good
cause’’ and establish an earlier effective
date. As explained above, we believe
that there is ‘‘good cause’’ for waiver of
the APA requirement for notice and
comment rulemaking because it would
be unnecessary for us to fulfill that
requirement. For the same reason, we
believe that the ‘‘good cause’’ exception
applies to the 60-day effective date
requirement for major rules in the
Congressional Review Act.
V. Regulatory Impact Statement
We have examined the impacts of this
notice as required by Executive Order
12866 (September 1993, Regulatory
Planning and Review), the Regulatory
Flexibility Act (RFA) (September 16,
1980, Pub. L. 96–354), section 1102(b) of
the Social Security Act, the Unfunded
Mandates Reform Act of 1995 (Pub. L.
104–4), and Executive Order 13132.
Executive Order 12866 directs
agencies to assess all costs and benefits
of available regulatory alternatives and,
if regulation is necessary, to select
regulatory approaches that maximize
net benefits (including potential
economic, environmental, public health
and safety effects, distributive impacts,
and equity). A regulatory impact
analysis (RIA) must be prepared for
major rules with economically
significant effects ($100 million or more
in any 1 year). As stated above, the AIF
(equal to the percentage increase in the
CPI–U of June 30, 2005 as compared to
June 30, 2004) for 2006 is 2.5 percent.
We estimate that the application of the
AIF will result in this notice being
considered a major rule because it will
result in an additional total program
expenditure of approximately $112
million in CY 2006.
The RFA requires agencies to analyze
options for regulatory relief of small
businesses. For purposes of the RFA,
small entities include small businesses,
VerDate Aug<31>2005
14:11 Nov 23, 2005
Jkt 205001
nonprofit organizations, and small
governmental jurisdictions. Most
hospitals and most other providers and
suppliers are small entities, either by
nonprofit status or by having revenues
of $6 million to $29 million in any 1
year. For purposes of the RFA, all
ambulance providers or suppliers are
considered to be small entities.
Individuals and States are not included
in the definition of a small entity.
The Department of Health and Human
Services (HHS) considers that a
substantial number of entities are
affected if the rule impacts more than 5
percent of the total number of small
entities as it does in this notice. This
notice will impact every ambulance
provider and supplier in the same way
because all ambulance payment rates for
all ambulance services furnished by all
types of ambulance providers and
suppliers are increased by the same
ambulance inflation factor. While all
ambulance payment rates are increased
by the 2.5 percent AIF, the impact of
this increase does not meet the
threshold established by HHS to be
considered a significant impact.
In addition, section 1102(b) of the Act
requires us to prepare a regulatory
impact analysis if a rule may have a
significant impact on the operations of
a substantial number of small rural
hospitals. For purposes of section
1102(b) of the Act, we define a small
rural hospital as a hospital that is
located outside of a Metropolitan
Statistical Area and has fewer than 100
beds. We have no data to indicate that
a substantial number of small rural
hospitals will be impacted by this
notice.
Section 202 of the Unfunded
Mandates Reform Act of 1995 also
requires that agencies assess anticipated
costs and benefits before issuing any
rule that may result in expenditure in
any 1 year by State, local, or tribal
governments, in the aggregate, or by the
private sector, of $110 million. This
notice does not result in expenditures in
any 1 year by State, local, or tribal
governments of $110 million.
Executive Order 13132 establishes
certain requirements that an agency
must meet when it publishes a notice
that imposes substantial direct
requirement costs on State and local
governments, preempts State law, or
otherwise has Federalism implications.
This notice will not have a substantial
effect on State or local governments.
We estimate that the total program
expenditure for CY 2006 for ambulance
services covered by the Medicare
program is approximately $4.5 billion.
Application of an AIF of 2.5 percent
will result in an additional total
PO 00000
Frm 00087
Fmt 4703
Sfmt 4703
71165
program expenditure of approximately
$112 million over CY 2005.
In accordance with the provisions of
Executive Order 12866, this regulation
was reviewed by the Office of
Management and Budget.
Authority: Section 1834(l) of the Social
Security Act (42 U.S.C. 1395m(l)).
(Catalog of Federal Domestic Assistance
Program No. 93.774, Medicare—
Supplementary Medical Insurance Program)
Dated: August 9, 2005.
Mark B. McClellan,
Administrator, Centers for Medicare &
Medicaid Services.
Approved: October 7, 2005.
Michael O. Leavitt,
Secretary.
[FR Doc. 05–23163 Filed 11–23–05; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N–0443]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Focus Groups as
Used by the Food and Drug
Administration
AGENCY:
Food and Drug Administration,
HHS.
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
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
focus groups as used by FDA to gauge
public opinion. Policymakers can use
focus group results to test and refine
their ideas so they can conduct further
research, as well as, adopt new policies
and to allocate or redirect significant
resources to support these policies.
DATES: Submit written or electronic
comments on the collection of
information by January 24, 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
E:\FR\FM\25NON1.SGM
25NON1
71166
Federal Register / Vol. 70, No. 226 / Friday, November 25, 2005 / Notices
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:
JonnaLynn P. Capezzuto, Office of
Management Programs (HFA–250), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–827–
4659.
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
SUPPLEMENTARY INFORMATION:
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.
Focus Groups as Used by the Food and
Drug Administration—(OMB Control
Number 0910–0497)
FDA will collect and use information
gathered through the focus group
vehicle. This information will be used
to develop programmatic proposals, and
as such, compliments other important
research findings to develop these
proposals. Focus groups do provide an
important role in gathering information
because they allow for a more in-depth
understanding of consumers’ attitudes,
beliefs, motivations, and feelings than
do quantitative studies.
Also, information from these focus
groups will be used to develop policy
and redirect resources, when necessary,
to our constituents. If this information is
not collected, a vital link in information
gathering by FDA to develop policy and
programmatic proposals will be missed
causing further delays in policy and
program development.
FDA estimates the burden for
completing the forms for this collection
of information as follows:
The total annual estimated burden
imposed by this collection of
information is 4,252 hours annually.
TABLE 1.1
Center
Center for Biologics Evaluation and Research
No. of Focus
Groups per
Study
Subject
No. of
Participants per
Group
Hours of Duration for Each
Group (Includes
Screening)
Total Hours
Center for Devices and Radiological Health
Center for Food Safety and
Applied Nutrition
Center for Veterinary Medicine
May Use Focus Groups
When Appropriate
1
5
9
1.58
71
Varies (e.g., Direct-toConsumer Rx Drug
Promotion, Physician
Labeling of Rx Drugs,
Medication Guides,
Over-the-Counter Drug
Labeling, Risk
Communication
10
200
9
1.58
2,844
Varies (e.g., FDA Seal
of Approval, Patient
Labeling, Tampons, Online Sales of Medical
Products, Latex Gloves
4
16
9
2.08
300
Varies (e.g., Food
Safety, Nutrition, Dietary
Supplements, Consumer
Education)
8
40
9
1.58
569
Varies (e.g., Animal
Nutrition, Supplements,
Labeling of Animal Rx)
5
25
9
2.08
468
28
Center for Drug Evaluation
and Research
286
1.78
4,252
Total
1There
No. of Focus
Groups
Sessions Conducted Annually
are no capital costs or operating and maintenance costs associated with this collection of information.
VerDate Aug<31>2005
14:11 Nov 23, 2005
Jkt 205001
PO 00000
Frm 00088
Fmt 4703
Sfmt 4703
E:\FR\FM\25NON1.SGM
25NON1
Federal Register / Vol. 70, No. 226 / Friday, November 25, 2005 / Notices
Annually, FDA projects about 28
focus group studies using 186 focus
groups lasting an average of 1.78 hours
each. FDA has allowed burden for
unplanned focus groups to be
completed so as not to restrict the
agency’s ability to gather information on
public sentiment for its proposals in its
regulatory as well as other programs.
Dated: November 14, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–23248 Filed 11–23–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HOMELAND
SECURITY
Transportation Security Administration
Extension Agency Information
Collection Activity Under OMB Review:
Department of Homeland Security—
Vulnerability Identification SelfAssessment Tool—Transportation
(DHS–VISAT–T)
Transportation Security
Administration (TSA), DHS.
ACTION: Notice.
AGENCY:
SUMMARY: This notice announces that
TSA has forwarded the Information
Collection Request (ICR) abstracted
below to the Office of Management and
Budget (OMB) for review and approval
of an extension of the currently
approved collection under the
Paperwork Reduction Act. The ICR
describes the nature of the information
collection and its expected burden. TSA
published a Federal Register notice,
with a 60-day comment period soliciting
comments, of the following collection of
information on September 23, 2005, 70
FR 55915.
DATES: Send your comments by
December 27, 2005. A comment to OMB
is most effective if OMB receives it
within 30 days of publication.
ADDRESSES: Comments may be faxed to
the Office of Information and Regulatory
Affairs, Office of Management and
Budget, Attention: DHS–TSA Desk
Officer, at (202) 395–5806.
FOR FURTHER INFORMATION CONTACT:
Katrina Wawer, Information Collection
Specialist, Office of Transportation
Security Policy, TSA–9, Transportation
Security Administration, 601 South
12th Street, Arlington, VA 22202–4220.
SUPPLEMENTARY INFORMATION:
Comments Invited
In accordance with the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501
(et seq.), an agency may not conduct or
VerDate Aug<31>2005
14:11 Nov 23, 2005
Jkt 205001
sponsor, and a person is not required to
respond to a collection of information,
unless it displays a valid OMB control
number. Therefore, in preparation for
OMB review and approval of the
following information collection, TSA is
soliciting comments to—
(1) Evaluate whether the proposed
information requirement is necessary for
the proper performance of the functions
of the agency, including whether the
information will have practical utility;
(2) Evaluate the accuracy of the
agency’s estimate of the burden;
(3) Enhance the quality, utility, and
clarity of the information to be
collected; and
(4) Minimize the burden of the
collection of information on those who
are to respond, including using
appropriate automated, electronic,
mechanical, or other technological
collection techniques or other forms of
information technology.
71167
DEPARTMENT OF HOUSING AND
URBAN DEVELOPMENT
[Docket No. FR–4971–N–60]
Notice of Submission of Proposed
Information Collection to OMB; Local
Appeals to Single-Family Mortgage
Limits
Office of the Chief Information
Officer, HUD.
ACTION: Notice.
AGENCY:
SUMMARY: The proposed information
collection requirement described below
has been submitted to the Office of
Management and Budget (OMB) for
review, as required by the Paperwork
Reduction Act. The Department is
soliciting public comments on the
subject proposal.
Housing industry groups may appeal
for increases in FHA’s maximum
mortgage limits for specific counties or
metropolitan statistical areas (MSA’s).
DATES: Comments Due Date: December
Information Collection Requirement
27, 2005.
ADDRESSES: Interested persons are
Title: Department of Homeland
invited to submit comments regarding
Security—Vulnerability Identification
this proposal. Comments should refer to
Self-Assessment Tool—Transportation
the proposal by name and/or OMB
(DHS–VISAT–T).
approval Number (2502–0302) and
Type of Request: Extension of a
should be sent to: HUD Desk Officer,
currently approved collection.
Office of Management and Budget, New
OMB Control Number: 1652–0037.
Executive Office Building, Washington,
Forms(s): Not applicable.
DC 20503; fax: 202–395–6974.
Affected Public: Various modal
FOR FURTHER INFORMATION CONTACT:
transportation sector owners and
Wayne Eddins, Reports Management
operators.
Officer, AYO, Department of Housing
and Urban Development, 451 Seventh
Abstract: This voluntary collection,
Street, SW., Washington, DC 20410; eby way of a web-based vulnerability
mail Wayne_Eddins@HUD.gov; or
assessment tool, allows TSA to gather
Lillian Deitzer at
security-related data and provides a
Lillian_L_Deitzer@HUD.gov or
cost-free service to the transportation
telephone (202) 708–2374. This is not a
sector. TSA designed this tool to be
toll-free number.
flexible to support the unique
Copies of available documents
characteristics of each transportation
submitted to OMB may be obtained
mode, while still providing a common
from Mr. Eddins or Ms Deitzer.
framework from which analysis and
trends can be identified. Users may use
SUPPLEMENTARY INFORMATION: This
the results of the assessment to develop
notice informs the public that the
a security plan or to identify areas of
Department of Housing and Urban
potential vulnerability. Information
Development has submitted to OMB a
regarding how to access the tool is
request for approval of the information
available on TSA’ Web site: https://
collection described below. This notice
www.tsa.gov. Select ‘‘Industry Partners,’’ is soliciting comments from members of
then ‘‘Risk Management,’’ then finally
the public and affecting agencies
select the ‘‘DHS–VISAT’’ link.
concerning the proposed collection of
information to: (1) Evaluate whether the
Number of Respondents: 300,245.
proposed collection of information is
Estimated Annual Burden Hours: An
necessary for the proper performance of
estimated 2,401,960 hours annually.
the functions of the agency, including
Issued in Arlington, Virginia, on November whether the information will have
18, 2005.
practical utility; (2) Evaluate the
Lisa S. Dean,
accuracy of the agency’s estimate of the
Privacy Officer.
burden of the proposed collection of
[FR Doc. 05–23243 Filed 11–23–05; 8:45 am]
information; (3) Enhance the quality,
utility, and clarity of the information to
BILLING CODE 4910–62–P
PO 00000
Frm 00089
Fmt 4703
Sfmt 4703
E:\FR\FM\25NON1.SGM
25NON1
]]>Agencies
[Federal Register Volume 70, Number 226 (Friday, November 25, 2005)]
[Notices]
[Pages 71165-71167]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-23248]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N-0443]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Focus Groups as Used by the Food and Drug
Administration
AGENCY: Food and Drug Administration, HHS.
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 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 focus groups as used by FDA to
gauge public opinion. Policymakers can use focus group results to test
and refine their ideas so they can conduct further research, as well
as, adopt new policies and to allocate or redirect significant
resources to support these policies.
DATES: Submit written or electronic comments on the collection of
information by January 24, 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
[[Page 71166]]
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: JonnaLynn P. Capezzuto, Office of
Management Programs (HFA-250), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-4659.
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 respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Focus Groups as Used by the Food and Drug Administration--(OMB Control
Number 0910-0497)
FDA will collect and use information gathered through the focus
group vehicle. This information will be used to develop programmatic
proposals, and as such, compliments other important research findings
to develop these proposals. Focus groups do provide an important role
in gathering information because they allow for a more in-depth
understanding of consumers' attitudes, beliefs, motivations, and
feelings than do quantitative studies.
Also, information from these focus groups will be used to develop
policy and redirect resources, when necessary, to our constituents. If
this information is not collected, a vital link in information
gathering by FDA to develop policy and programmatic proposals will be
missed causing further delays in policy and program development.
FDA estimates the burden for completing the forms for this
collection of information as follows:
The total annual estimated burden imposed by this collection of
information is 4,252 hours annually.
Table 1.\1\
----------------------------------------------------------------------------------------------------------------
No. of Focus Hours of
No. of Focus Groups No. of Duration for
Center Subject Groups per Sessions Participants Each Group Total Hours
Study Conducted per Group (Includes
Annually Screening)
----------------------------------------------------------------------------------------------------------------
Center May Use Focus Groups 1 5 9 1.58 71
for When Appropriate
Biologi
cs
Evaluat
ion and
Researc
h
----------------------------------------------------------------------------------------------------------------
Center Varies (e.g., Direct-to- 10 200 9 1.58 2,844
for Consumer Rx Drug
Drug Promotion, Physician
Evaluat Labeling of Rx Drugs,
ion and Medication Guides, Over-
Researc the-Counter Drug
h Labeling, Risk
Communication
----------------------------------------------------------------------------------------------------------------
Center Varies (e.g., FDA Seal 4 16 9 2.08 300
for of Approval, Patient
Devices Labeling, Tampons, On-
and line Sales of Medical
Radiolo Products, Latex Gloves
gical
Health
----------------------------------------------------------------------------------------------------------------
Center Varies (e.g., Food 8 40 9 1.58 569
for Safety, Nutrition,
Food Dietary Supplements,
Safety Consumer Education)
and
Applied
Nutriti
on
----------------------------------------------------------------------------------------------------------------
Center Varies (e.g., Animal 5 25 9 2.08 468
for Nutrition, Supplements,
Veterin Labeling of Animal Rx)
ary
Medicin
e
----------------------------------------------------------------------------------------------------------------
Total ........................ 28 286 .............. 1.78 4,252
----------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
[[Page 71167]]
Annually, FDA projects about 28 focus group studies using 186 focus
groups lasting an average of 1.78 hours each. FDA has allowed burden
for unplanned focus groups to be completed so as not to restrict the
agency's ability to gather information on public sentiment for its
proposals in its regulatory as well as other programs.
Dated: November 14, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-23248 Filed 11-23-05; 8:45 am]
BILLING CODE 4160-01-S
