Agency Emergency Processing Under the Office of Management and Budget Review; Submission for Office of Management and Budget Review; Comment Request; Food and Drug Administration Food Safety Modernization Act: Economic Hardship Fee Reduction Guidance, 72712-72713 [2011-30471]
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72712
Federal Register / Vol. 76, No. 227 / Friday, November 25, 2011 / Notices
Dated: November 18, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–30327 Filed 11–23–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0841]
Agency Emergency Processing Under
the Office of Management and Budget
Review; Submission for Office of
Management and Budget Review;
Comment Request; Food and Drug
Administration Food Safety
Modernization Act: Economic Hardship
Fee Reduction Guidance
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995
(PRA). The proposed collection of
information concerns a guidance
document that outlines the criteria and
the process through which firms may
request a reduction of fees based on
severe economic hardship of the FDA
Food Safety Modernization Act (FSMA)
reinspection and recall user fees that are
mandated by the Federal Food, Drug,
and Cosmetic Act (the FD&C Act).
DATES: Fax written comments on the
collection of information by December
15, 2011. FDA is requesting OMB
approval of this emergency processing
by January 6, 2012.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
(202) 395–7285, or emailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–New and
title ‘‘FDA Food Safety Modernization
Act: Economic Hardship Fee Reduction
Guidance.’’ Also include the FDA
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Denver Presley, Jr., Office of Information
wreier-aviles on DSK7SPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
14:31 Nov 23, 2011
Jkt 226001
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, (301) 796–
3793.
SUPPLEMENTARY INFORMATION: FDA has
requested emergency processing of this
proposed collection of information
under section 3507(j) of the PRA (44
U.S.C. 3507(j) and 5 CFR 1320.13). FDA
requests permission to use the
emergency clearance procedures to
obtain OMB approval of the information
collection related to the economic
hardship fee reduction guidance. FDA
expects to use a print-and-mail or an
email form for fee reduction requests. If
FDA were to use the normal clearance
procedures, the approval of the
information collection would not be
finalized in time to issue invoices in
January 2012. FDA seeks OMB approval
of the information collection by January
6, 2012, so the Agency can issue such
guidance no later than January 2012.
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.
FDA Food Safety Modernization Act:
Economic Hardship Fee Reduction
Guidance (OMB Control Number 0910–
NEW)
On January 4, 2011, the President
signed into law FSMA (Pub. L. 111–
353). Section 743 of the FD&C Act (21
U.S.C. 379j–31) amended by FSMA,
requires FDA to consider the burden of
fee amounts on small businesses.
Section 743(b)(2)(B)(iii) of FD&C Act
states, ‘‘* * *the Secretary shall publish
in the Federal Register a proposed set
of guidelines in consideration of the
burden of fee amounts on small
business. Such consideration may
include reduced fee amounts for small
businesses.* * *’’ Before publishing such
guidelines, FDA believes it is important
to gather additional information related
PO 00000
Frm 00041
Fmt 4703
Sfmt 4703
to small business burdens associated
with fees to set forth criteria and a
rational for such criteria for when a user
fee reduction is appropriate. Therefore,
FDA published a document in the
Federal Register of August 1, 2011 (76
FR 45818) (FRN) to seek public
comments and information to assist the
Agency to develop such guidelines.
FDA will review the comments
(comment period closes on November
30, 2011) and then develop the
proposed set of guidelines; these will
likely be implemented in fiscal year
(FY) 2013. However, FDA recognizes
that, meanwhile, for some small
businesses the reinspection or the recall
user fees, which went into effect on
October 1, 2011, could impose severe
economic hardship and there may be
unique circumstances in which some
relief would be appropriate. During FY
2012, FDA will consider waiving some
or all of an invoiced fee based on a
severe economic hardship. FDA intends
to protect businesses and preserve free
competitive enterprise.
FDA is currently developing a
guidance to outline the criteria and the
process through which firms may
request a reduction of fees based on
economic hardship. FDA wants to
consider the public comments from the
small business FRN before finalizing
such guidance. Also, in the recent
‘‘Guidance for Industry: Implementation
of the Fee Provisions of Section 107 of
the FDA Food Safety Modernization
Act’’ that published in the Federal
Register of October 6, 2011 (76 FR
62073), FDA stated that it would ‘‘not
intend to issue invoices for reinspection
or recall order fees until this guidance
document has been finalized.’’
Therefore, FDA needs to publish such
guidance soon after November 30, 2011,
in order to: (1) Issue invoices and
(2) provide important information for
qualified firms to apply for fee
reductions, which will help them to
sustain their businesses. Given such a
short timeframe, use of the normal
clearance process to obtain OMB
approval under the PRA for the
information collection related to the
economic hardship fee reduction
guidance is likely to cause delay of
publishing such guidance and
subsequently cause delay of issuing
invoices. The fees, required by FSMA,
are to cover 100 percent of the costs of
certain reinspection and recall order
activities conducted by FDA.
FDA estimates the burden of this
collection of information as follows:
E:\FR\FM\25NON1.SGM
25NON1
72713
Federal Register / Vol. 76, No. 227 / Friday, November 25, 2011 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
Respondents
Activity
Number of
Responses per
Respondent
Total annual
responses
235
1
235
Request for reduction of fees collected under section 743 of the FD&C Act .......................................
1 There
Total hours
2
470
are no capital costs or operating and maintenance costs associated with this collection of information.
FDA estimates that 510 facilities will
be subject to the reinspection and the
recall fees under section 743 of the
FD&C Act. Of these facilities, we
estimate that 46 percent will be small
businesses with annual gross sales
under $250,000. Therefore, 46 percent
of 510 equals to 235 respondents. Each
respondent will submit 1 request for
reduction of fees. Total annual
responses are 235. The average burden
is 2 hours, giving a total of 470 hours
annual burden.
Dated: November 22, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–30411 Filed 11–23–11; 8:45 am]
BILLING CODE 4165–15–P
Government-Owned Inventions;
Availability for Licensing
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health,
Public Health Service, HHS.
ACTION: Notice.
AGENCY:
Health Resources and Services
Administration
Statement of Delegation of Authority
I hereby delegate to the
Administrator, Health Resources and
Services Administration (HRSA), and
the Director, Centers for Disease Control
and Prevention (CDC), with authority to
redelegate, the authority vested in the
Secretary under Title III, Part P, Section
399T (42 U.S.C. 280g–8), titled ‘‘Support
for Patients Receiving a Positive
Diagnosis of Down Syndrome or Other
Prenatally or Postnatally Diagnosed
Conditions,’’ of the Public Health
Service Act, as amended, insofar as such
authority pertains to the functions of
HRSA and CDC, respectively. HRSA and
CDC will coordinate and collaborate
with each other and with the National
Institutes of Health, as appropriate, in
implementing this authority.
This delegation excludes the authority
to issue regulations, to establish
advisory committees and councils, and
appoint their members, and shall be
exercised in accordance with the
Department’s applicable policies,
procedures, and guidelines.
Jkt 226001
The inventions listed below
are owned by an agency of the U.S.
Government and are available for
licensing in the U.S. in accordance with
35 U.S.C. 207 to achieve expeditious
commercialization of results of
federally-funded research and
development. Foreign patent
applications are filed on selected
inventions to extend market coverage
for companies and may also be available
for licensing.
ADDRESSES: Licensing information and
copies of the U.S. patent applications
listed below may be obtained by writing
to the indicated licensing contact at the
Office of Technology Transfer, National
Institutes of Health, 6011 Executive
Boulevard, Suite 325, Rockville,
Maryland 20852–3804; telephone: (301)
496–7057; fax: (301) 402–0220. A signed
Confidential Disclosure Agreement will
be required to receive copies of the
patent applications.
SUMMARY:
Centers for Disease Control and
Prevention
14:31 Nov 23, 2011
Dated: November 14, 2011.
Kathleen Sebelius,
Secretary.
National Institutes of Health
BILLING CODE 4160–01–P
VerDate Mar<15>2010
I hereby affirm and ratify any actions
taken by the Administrator, HRSA, the
Director, CDC, or other HRSA and CDC
officials, which involve the exercise of
these authorities prior to the effective
date of this delegation.
This delegation is effective upon date
of signature.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2011–30471 Filed 11–22–11; 11:15 am]
wreier-aviles on DSK7SPTVN1PROD with NOTICES
Average
burden per
response
Genetically Engineered Mouse Model
for Use as an Alternative Screening
Method for Evaluating P-glycoprotein
(P-gp) Substrate Toxicity in
Avermectin-sensitive Dogs
Description of Technology: A pitfall to
avermectins is central nervous system
PO 00000
Frm 00042
Fmt 4703
Sfmt 4703
(CNS) toxicities in herding dogs. As a
result, all new avermectins must be
tested in a ‘‘Collie Safety Study’’ to
determine the degree of CNS toxicity.
The toxicity is due to a 4 base pair
mutation in the ATP-binding cassette,
sub-family B member 1 (ABCB1) gene.
This gene encodes for the Pglycoprotein (P-gp) that affects
absorption, distribution and elimination
of certain drugs. Researchers at FDA
have developed an alternate animal
model that includes two transgenic
mouse models, one containing the
mutant form of the canine ABCB1 gene
(Yancy 1 line) and the other containing
the canine wild-type gene (Yancy 2
line). The paired mouse system can be
utilized to assess the safety of
avermectins and other canine drugs by
determining the toxicity to canines with
the mutated form of the ABCB1 gene.
Ivermectin, a derivative of the
avermectin family of heartworm drugs
used to treat and control parasitic
infections, was used to verify this
mouse model. This technology will
enhance the population predictions
derived from clinical safety data and
serve to reduce the use of dogs in
avermectin derivative safety studies that
are part of the Investigational New
Animal Drug (INAD) approval process.
Potential Commercial Applications:
Drug screening technology to assess the
toxicity of canine drugs to canines with
the mutated form of the ABCB1 gene.
Competitive Advantages: Use as an
alternative in vivo model to canines for
assessment of drug safety in the
presence of the ABCB1 mutation.
Development Stage: In vivo data
available (animal).
Inventor: Haile F. Yancy (FDA).
Publication: Orzechowski K, et al., in
press Am J Vet Res.
Intellectual Property: HHS Reference
No. E–292–2011/0—Research Tool.
Patent protection is not being pursued
for this technology.
Licensing Contact: Jaime Greene; (301)
435–5559; greenejaime@mail.nih.gov.
Collaborative Research Opportunity:
The FDA Center for Veterinary
Medicine is seeking statements of
capability or interest from parties
interested in collaborative research to
further develop, evaluate or
E:\FR\FM\25NON1.SGM
25NON1
]]>Agencies
[Federal Register Volume 76, Number 227 (Friday, November 25, 2011)]
[Notices]
[Pages 72712-72713]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-30471]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0841]
Agency Emergency Processing Under the Office of Management and
Budget Review; Submission for Office of Management and Budget Review;
Comment Request; Food and Drug Administration Food Safety Modernization
Act: Economic Hardship Fee Reduction Guidance
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995 (PRA). The proposed collection of
information concerns a guidance document that outlines the criteria and
the process through which firms may request a reduction of fees based
on severe economic hardship of the FDA Food Safety Modernization Act
(FSMA) reinspection and recall user fees that are mandated by the
Federal Food, Drug, and Cosmetic Act (the FD&C Act).
DATES: Fax written comments on the collection of information by
December 15, 2011. FDA is requesting OMB approval of this emergency
processing by January 6, 2012.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX: (202) 395-7285, or emailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-New and
title ``FDA Food Safety Modernization Act: Economic Hardship Fee
Reduction Guidance.'' Also include the FDA docket number found in
brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, (301) 796-3793.
SUPPLEMENTARY INFORMATION: FDA has requested emergency processing of
this proposed collection of information under section 3507(j) of the
PRA (44 U.S.C. 3507(j) and 5 CFR 1320.13). FDA requests permission to
use the emergency clearance procedures to obtain OMB approval of the
information collection related to the economic hardship fee reduction
guidance. FDA expects to use a print-and-mail or an email form for fee
reduction requests. If FDA were to use the normal clearance procedures,
the approval of the information collection would not be finalized in
time to issue invoices in January 2012. FDA seeks OMB approval of the
information collection by January 6, 2012, so the Agency can issue such
guidance no later than January 2012.
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.
FDA Food Safety Modernization Act: Economic Hardship Fee Reduction
Guidance (OMB Control Number 0910-NEW)
On January 4, 2011, the President signed into law FSMA (Pub. L.
111-353). Section 743 of the FD&C Act (21 U.S.C. 379j-31) amended by
FSMA, requires FDA to consider the burden of fee amounts on small
businesses.
Section 743(b)(2)(B)(iii) of FD&C Act states, ``* * *the Secretary
shall publish in the Federal Register a proposed set of guidelines in
consideration of the burden of fee amounts on small business. Such
consideration may include reduced fee amounts for small businesses.* *
*'' Before publishing such guidelines, FDA believes it is important to
gather additional information related to small business burdens
associated with fees to set forth criteria and a rational for such
criteria for when a user fee reduction is appropriate. Therefore, FDA
published a document in the Federal Register of August 1, 2011 (76 FR
45818) (FRN) to seek public comments and information to assist the
Agency to develop such guidelines. FDA will review the comments
(comment period closes on November 30, 2011) and then develop the
proposed set of guidelines; these will likely be implemented in fiscal
year (FY) 2013. However, FDA recognizes that, meanwhile, for some small
businesses the reinspection or the recall user fees, which went into
effect on October 1, 2011, could impose severe economic hardship and
there may be unique circumstances in which some relief would be
appropriate. During FY 2012, FDA will consider waiving some or all of
an invoiced fee based on a severe economic hardship. FDA intends to
protect businesses and preserve free competitive enterprise.
FDA is currently developing a guidance to outline the criteria and
the process through which firms may request a reduction of fees based
on economic hardship. FDA wants to consider the public comments from
the small business FRN before finalizing such guidance. Also, in the
recent ``Guidance for Industry: Implementation of the Fee Provisions of
Section 107 of the FDA Food Safety Modernization Act'' that published
in the Federal Register of October 6, 2011 (76 FR 62073), FDA stated
that it would ``not intend to issue invoices for reinspection or recall
order fees until this guidance document has been finalized.''
Therefore, FDA needs to publish such guidance soon after November 30,
2011, in order to: (1) Issue invoices and (2) provide important
information for qualified firms to apply for fee reductions, which will
help them to sustain their businesses. Given such a short timeframe,
use of the normal clearance process to obtain OMB approval under the
PRA for the information collection related to the economic hardship fee
reduction guidance is likely to cause delay of publishing such guidance
and subsequently cause delay of issuing invoices. The fees, required by
FSMA, are to cover 100 percent of the costs of certain reinspection and
recall order activities conducted by FDA.
FDA estimates the burden of this collection of information as
follows:
[[Page 72713]]
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity Number of Responses per Total annual Average burden Total hours
Respondents Respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Request for reduction of fees collected under section 743 of the 235 1 235 2 470
FD&C Act..........................................................
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
FDA estimates that 510 facilities will be subject to the
reinspection and the recall fees under section 743 of the FD&C Act. Of
these facilities, we estimate that 46 percent will be small businesses
with annual gross sales under $250,000. Therefore, 46 percent of 510
equals to 235 respondents. Each respondent will submit 1 request for
reduction of fees. Total annual responses are 235. The average burden
is 2 hours, giving a total of 470 hours annual burden.
Dated: November 22, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-30471 Filed 11-22-11; 11:15 am]
BILLING CODE 4160-01-P
