Emergency Clearance: Public Information Collection Requirements Submitted to the Office of Management and Budget (OMB), 46432-46433 [E9-21674]
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Federal Register / Vol. 74, No. 173 / Wednesday, September 9, 2009 / Notices
Estimated Annual Reporting Burden for
Biological Products in the Center for
Biologics Evaluation and Research
Under § 312.23(a)(7)(iv)(e) and
601.2(a), INDs and BLAs must contain a
claim for categorical exclusion under
§ 25.30 or § 25.31 or an EA under
§ 25.40. In 2008, FDA received 245 INDs
from 180 sponsors, 28 BLAs from 13
applicants, and 972 BLA supplements to
license applications from 173
applicants. FDA estimates that
approximately 10 percent of these
supplements would be submitted with a
claim for categorical exclusion or an EA.
FDA estimates that it received
approximately 370 claims for categorical
exclusion as required under § 25.15(a)
and (d), and 2 EAs as required under
§ 25.40(a) and (c). Based on information
provided by industry, FDA estimates
that it takes sponsors and applicants
approximately 8 hours to prepare a
claim for categorical exclusion and
approximately 3,400 hours to prepare an
EA for a biological product.
TABLE 4.—ESTIMATED ANNUAL REPORTING BURDEN FOR BIOLOGICAL PRODUCTS1
No. of
Respondents
21 CFR Section
Annual Frequency
per Response
25.15(a) and (d)
210
25.40(a) and (c)
2
Total Annual
Responses
1.76
Hours per
Response
Total Hours
370
8
2,960
2
3,400
6,800
1
Total
1 There
9,760
are no capital costs or operating and maintenance costs associated with this collection of information.
Estimated Annual Reporting Burden for
Animal Drugs
Under 21 CFR 514.1(b)(14), new
animal drug applications (NADAs) and
abbreviated new animal drug
applications (ANADAs); 21 CFR
514.8(a)(1) supplemental NADAs and
ANADAs; 21 CFR 511.1(b)(10)
investigational new animal drug
applications (INADs); and 21 CFR
571.1(c) food additive petitions must
contain a claim for categorical exclusion
under § 25.30 or § 25.33 or an EA under
§ 25.40. In 2008, FDA’s Center for
Veterinary Medicine received
approximately 676 claims for categorical
exclusion as required under § 25.15(a)
and (d), and 8 EAs as required under
§ 25.40(a) and (c). FDA estimates that it
takes sponsors/applicants
approximately 5 hours to prepare a
claim for a categorical exclusion and an
average of 2,160 hours to prepare an EA.
TABLE 5.—ESTIMATED ANNUAL REPORTING BURDEN FOR ANIMAL DRUGS1
21 CFR Section
No. of
Respondents
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total Hours
25.15(a) and (d)
65
10.4
676
5
3,380
25.40(a) and (c)
6
1.3
8
2,160
17,280
Total
1 There
20,660
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 6.—COMBINED ESTIMATED ANNUAL TOTAL BURDEN HOURS FOR ALL CENTERS
Total
193,797
Dated: August 28, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9–21724 Filed 9–8–09; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare and Medicaid
Services
BILLING CODE 4160–01–S
[Document Identifier: CMS–10295]
cprice-sewell on DSK2BSOYB1PROD with NOTICES
Emergency Clearance: Public
Information Collection Requirements
Submitted to the Office of Management
and Budget (OMB)
AGENCY: Center for Medicare and
Medicaid Services, Department of
Health and Human Services.
In compliance with the requirement
of section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the
Centers for Medicare and Medicaid
Services (CMS), Department of Health
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and Human Services, is publishing the
following summary of proposed
collections for public comment.
Interested persons are invited to send
comments regarding this burden
estimate or any other aspect of this
collection of information, including any
of the following subjects: (1) The
necessity and utility of the proposed
information collection for the proper
performance of the agency’s functions;
(2) the accuracy of the estimated
burden; (3) ways to enhance the quality,
utility, and clarity of the information to
be collected; and (4) the use of
automated collection techniques or
other forms of information technology to
minimize the information collection
burden.
E:\FR\FM\09SEN1.SGM
09SEN1
cprice-sewell on DSK2BSOYB1PROD with NOTICES
Federal Register / Vol. 74, No. 173 / Wednesday, September 9, 2009 / Notices
We are, however, requesting an
emergency review of the information
collection referenced below. In
compliance with the requirement of
section 3506(c)(2)(A) of the Paperwork
Reduction Act of 1995, we have
submitted to the Office of Management
and Budget (OMB) the following
requirements for emergency review. We
are requesting emergency approval
under 5 CFR 1320.13(a)(2)(iii), as we
believe that the use of normal clearance
procedures is reasonably likely to cause
a statutory deadline to be missed for
annual reports to Congress as required
under sections 5001 and 5004 of the
Recovery Act.
1. Type of Information Collection
Request: New collection; Title of
Information Collection: Recovery Act—
Reporting Requirements for States
Under FMAP Increase and TMA
Provisions; Use: The American
Recovery and Reinvestment Act of 2009
(Recovery Act), Public Law 111–5,
requires that States submit quarterly
reports to the Secretary of Health and
Human Services in accordance with
section 5001 Temporary Increase of
Medicaid Federal Medical Assistance
Percentage (FMAP) and section 5004(d)
Extension of Transitional Medical
Assistance (TMA). The reports under
section 5001 are required for the period
of October 1, 2008–September 30, 2011.
The reports under section 5004 are
required beginning on July 1, 2009 until
the Federal authority for TMA coverage
sunsets (now scheduled to sunset on
December 31, 2010). Each State
Medicaid agency will submit its
quarterly reports to the appropriate
Regional Office of CMS. The reports will
be compiled and summarized for annual
reports to Congress. Form Number:
CMS–10295 (OMB#: 0938–New);
Frequency: Reporting—Quarterly;
Affected Public: State, Local, or Tribal
Governments; Number of Respondents:
50; Total Annual Responses: 200; Total
Annual Hours: 600. (For policy
questions regarding this collection
contact Richard Strauss at 410–786–
2019. For all other issues call 410–786–
1326.)
CMS is requesting OMB review and
approval of this collection by October 5,
2009, with a 180-day approval period.
Written comments and recommendation
will be considered from the public if
received by the individuals designated
below by the noted deadline below.
To obtain copies of the supporting
statement and any related forms for the
proposed paperwork collections
referenced above, access CMS’s Web
Site address at https://www.cms.hhs.gov/
PaperworkReductionActof1995 or Email your request, including your
VerDate Nov<24>2008
15:47 Sep 08, 2009
Jkt 217001
address, phone number, OMB number,
and CMS document identifier, to
Paperwork@cms.hhs.gov, or call the
Reports Clearance Office on (410) 786–
1326.
In commenting on the proposed
information collections please reference
the document identifier or OMB control
number. To be assured consideration,
comments and recommendations must
be submitted in one of the following
ways by October 9, 2009:
1. Electronically. You may submit
your comments electronically to
https://www.regulations.gov. Follow the
instructions for ‘‘Comment or
Submission’’ or ‘‘More Search Options’’
to find the information collection
document(s) accepting comments.
2. By regular mail. You may mail
written comments to the following
address: CMS, Office of Strategic
Operations and Regulatory Affairs,
Division of Regulations Development,
Attention: Document Identifier/OMB
Control Number (CMS–10295), Room
C4–26–05, 7500 Security Boulevard,
Baltimore, Maryland 21244–1850.
and,
OMB Office of Information and
Regulatory Affairs, Attention: CMS Desk
Officer, New Executive Office Building,
Room 10235, Washington, DC 20503.
Fax Number: (202) 395–6974.
Dated: August 31, 2009.
Michelle Shortt,
Director, Regulations Development Group,
Office of Strategic Operations and Regulatory
Affairs.
[FR Doc. E9–21674 Filed 9–8–09; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–D–0386]
Draft Guidance for Industry and Food
and Drug Administration Staff;
Establishing the Performance
Characteristics of In Vitro Diagnostic
Devices for the Detection or Detection
and Differentiation of Human
Papillomaviruses; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of the draft guidance
entitled ‘‘Establishing the Performance
Characteristics of In Vitro Diagnostic
Devices for the Detection or Detection
and Differentiation of Human
PO 00000
Frm 00027
Fmt 4703
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46433
Papillomaviruses.’’ FDA is issuing this
draft guidance to inform industry and
agency staff of its recommendations for
analytical and clinical performance
studies to support premarket
submissions for in vitro diagnostic
devices intended for the detection or
detection and differentiation of human
papillomaviruses.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115 (g)(5)), to ensure that the agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
written or electronic comments on the
draft guidance by December 8, 2009.
ADDRESSES: Submit written requests for
single copies of the draft guidance
document entitled ‘‘Establishing the
Performance Characteristics of In Vitro
Diagnostic Devices for the Detection or
Detection and Differentiation of Human
Papillomaviruses’’ to the Division of
Small Manufacturers, International, and
Consumer Assistance, Center for
Devices and Radiological Health, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, rm. 4613,
Silver Spring, MD 20993. Send one selfaddressed adhesive label to assist that
office in processing your request, or fax
your request to 301–847–8149. See the
SUPPLEMENTARY INFORMATION
section for information on electronic
access to the guidance.
Submit written comments concerning
this draft guidance to the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852.
Submit electronic comments to https://
www.regulations.gov. Identify
comments with the docket number
found in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT: Kate
Simon, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, rm. 5552, Silver Spring,
MD 20993, 301–796–6204.
SUPPLEMENTARY INFORMATION:
I. Background
This draft guidance document
recommends studies that may be used to
establish the analytical and clinical
performance of in vitro diagnostic
devices (IVDs) for the detection or
detection and differentiation of human
papillomaviruses (HPV) in cervical
specimens. This guidance is limited to
studies intended to establish the
performance characteristics of in vitro
diagnostic HPV devices that are used in
conjunction with cervical cytology for
cervical cancer screening. It does not
E:\FR\FM\09SEN1.SGM
09SEN1
Agencies
[Federal Register Volume 74, Number 173 (Wednesday, September 9, 2009)]
[Notices]
[Pages 46432-46433]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-21674]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare and Medicaid Services
[Document Identifier: CMS-10295]
Emergency Clearance: Public Information Collection Requirements
Submitted to the Office of Management and Budget (OMB)
AGENCY: Center for Medicare and Medicaid Services, Department of Health
and Human Services.
In compliance with the requirement of section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the Centers for Medicare and Medicaid
Services (CMS), Department of Health and Human Services, is publishing
the following summary of proposed collections for public comment.
Interested persons are invited to send comments regarding this burden
estimate or any other aspect of this collection of information,
including any of the following subjects: (1) The necessity and utility
of the proposed information collection for the proper performance of
the agency's functions; (2) the accuracy of the estimated burden; (3)
ways to enhance the quality, utility, and clarity of the information to
be collected; and (4) the use of automated collection techniques or
other forms of information technology to minimize the information
collection burden.
[[Page 46433]]
We are, however, requesting an emergency review of the information
collection referenced below. In compliance with the requirement of
section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, we have
submitted to the Office of Management and Budget (OMB) the following
requirements for emergency review. We are requesting emergency approval
under 5 CFR 1320.13(a)(2)(iii), as we believe that the use of normal
clearance procedures is reasonably likely to cause a statutory deadline
to be missed for annual reports to Congress as required under sections
5001 and 5004 of the Recovery Act.
1. Type of Information Collection Request: New collection; Title of
Information Collection: Recovery Act--Reporting Requirements for States
Under FMAP Increase and TMA Provisions; Use: The American Recovery and
Reinvestment Act of 2009 (Recovery Act), Public Law 111-5, requires
that States submit quarterly reports to the Secretary of Health and
Human Services in accordance with section 5001 Temporary Increase of
Medicaid Federal Medical Assistance Percentage (FMAP) and section
5004(d) Extension of Transitional Medical Assistance (TMA). The reports
under section 5001 are required for the period of October 1, 2008-
September 30, 2011. The reports under section 5004 are required
beginning on July 1, 2009 until the Federal authority for TMA coverage
sunsets (now scheduled to sunset on December 31, 2010). Each State
Medicaid agency will submit its quarterly reports to the appropriate
Regional Office of CMS. The reports will be compiled and summarized for
annual reports to Congress. Form Number: CMS-10295 (OMB: 0938-
New); Frequency: Reporting--Quarterly; Affected Public: State, Local,
or Tribal Governments; Number of Respondents: 50; Total Annual
Responses: 200; Total Annual Hours: 600. (For policy questions
regarding this collection contact Richard Strauss at 410-786-2019. For
all other issues call 410-786-1326.)
CMS is requesting OMB review and approval of this collection by
October 5, 2009, with a 180-day approval period. Written comments and
recommendation will be considered from the public if received by the
individuals designated below by the noted deadline below.
To obtain copies of the supporting statement and any related forms
for the proposed paperwork collections referenced above, access CMS's
Web Site address at https://www.cms.hhs.gov/PaperworkReductionActof1995
or E-mail your request, including your address, phone number, OMB
number, and CMS document identifier, to Paperwork@cms.hhs.gov, or call
the Reports Clearance Office on (410) 786-1326.
In commenting on the proposed information collections please
reference the document identifier or OMB control number. To be assured
consideration, comments and recommendations must be submitted in one of
the following ways by October 9, 2009:
1. Electronically. You may submit your comments electronically to
https://www.regulations.gov. Follow the instructions for ``Comment or
Submission'' or ``More Search Options'' to find the information
collection document(s) accepting comments.
2. By regular mail. You may mail written comments to the following
address: CMS, Office of Strategic Operations and Regulatory Affairs,
Division of Regulations Development, Attention: Document Identifier/OMB
Control Number (CMS-10295), Room C4-26-05, 7500 Security Boulevard,
Baltimore, Maryland 21244-1850.
and,
OMB Office of Information and Regulatory Affairs, Attention: CMS
Desk Officer, New Executive Office Building, Room 10235, Washington, DC
20503. Fax Number: (202) 395-6974.
Dated: August 31, 2009.
Michelle Shortt,
Director, Regulations Development Group, Office of Strategic Operations
and Regulatory Affairs.
[FR Doc. E9-21674 Filed 9-8-09; 8:45 am]
BILLING CODE 4120-01-P