Agency Information Collection Activities; Proposed Collection; Comment Request; Request for Samples and Protocols, 9820-9822 [E9-4750]
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9820
Federal Register / Vol. 74, No. 43 / Friday, March 6, 2009 / Notices
668B (OMB# 0938–0653); Frequency:
Biennially; Affected Public: Business or
other for-profits and not-for-profit
institutions. State, Local, or Tribal
Government, Federal Government;
Number of Respondents: 21,000; Total
Annual Responses: 10,500; Total
Annual Hours: 2,625. (For policy
questions regarding this collection
contact Kathleen Todd at 410–786–
3385. For all other issues call 410–786–
1326.)
To obtain copies of the supporting
statement and any related forms for the
proposed paperwork collections
referenced above, access CMS Web site
address at https://www.cms.hhs.gov/
PaperworkReductionActof1995, or email 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.
To be assured consideration,
comments and recommendations for the
proposed information collections must
be received by the OMB desk officer at
the address below, no later than 5 p.m.
on April 6, 2009.
OMB, Office of Information and
Regulatory Affairs, Attention: CMS Desk
Officer, Fax Number: (202) 395–6974,
E-mail: OIRA_submission@omb.eop.gov.
Dated: February 27, 2009.
Michelle Shortt,
Director, Regulations Development Group,
Office of Strategic Operations and Regulatory
Affairs.
[FR Doc. E9–4791 Filed 3–5–09; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–10165]
mstockstill on PROD1PC66 with NOTICES
Agency Information Collection
Activities: Proposed Collection;
Comment Request
AGENCY: Centers for Medicare &
Medicaid Services, HHS.
In compliance with the requirement
of section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the
Centers for Medicare & Medicaid
Services (CMS) 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
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Jkt 217001
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.
1. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
Information Collection: Electronic
Health Records (EHR) Demonstration
Web Enabled Application for Phase II;
Use: The goal of the Electronic Health
Record (EHR) demonstration is to foster
the implementation and adoption of
EHRs and Health Information
Technology (HIT) more broadly as
effective vehicles improve the quality of
care provided and transform the way
medicine is practiced and delivered.
Adoption of HIT has the potential to
provide significant savings to the
Medicare program and improve the
quality of care rendered to Medicare
beneficiaries. This demonstration is
designed to leverage the combined
forces of private and public payers to
drive physician practices to widespread
adoption and use of EHRs. The
demonstration is being implemented in
two phases. Over 800 applications were
received, via a manual (paper) process,
from interested practices in the four
Phase I sites. Because of the greater
number of sites and projected applicants
for Phase II, CMS has Web enabled the
application. This is expected to make it
easier for practices to complete the
application accurately and completely,
submit it in a timely manner, and allow
CMS to process the applications more
efficiently and effectively. Form
Number: CMS–10165(OMB#: 0938–
0936–0965); Frequency: Reporting—
Once; Affected Public: Business or other
for-profit and not-for-profit institutions;
Number of Respondents: 1,600; Total
Annual Responses: 1,600; Total Annual
Hours: 347. (For policy questions
regarding this collection contact Jody
Blatt at 410–786–6921. For all other
issues call 410–786–1326.)
To obtain copies of the supporting
statement and any related forms for the
proposed paperwork collections
referenced above, access CMS’ Web Site
at https://www.cms.hhs.gov/
PaperworkReductionActof1995, or email 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.
PO 00000
Frm 00042
Fmt 4703
Sfmt 4703
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 May 5, 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 lll, Room C4–26–
05, 7500 Security Boulevard, Baltimore,
Maryland 21244–1850.
Dated: February 27, 2009.
Michelle Shortt,
Director, Regulations Development Group,
Office of Strategic Operations and Regulatory
Affairs.
[FR Doc. E9–4807 Filed 3–5–09; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0097]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Request for
Samples and Protocols
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
the information collection requirements
relating to the regulations which state
that protocols for samples of biological
products must be submitted to the
agency.
DATES: Submit written or electronic
comments on the collection of
information by May 5, 2009.
E:\FR\FM\06MRN1.SGM
06MRN1
Federal Register / Vol. 74, No. 43 / Friday, March 6, 2009 / Notices
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:
Jonna Capezzuto, Office of Information
Management (HFA–710), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–796–3794.
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.
mstockstill on PROD1PC66 with NOTICES
ADDRESSES:
Request for Samples and Protocols
(OMB Control Number 0910–0206)—
Extension
Under section 351 of the Public
Health Service Act (42 U.S.C. 262), FDA
has the responsibility to issue
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16:20 Mar 05, 2009
Jkt 217001
regulations that prescribe standards
designed to ensure the safety, purity,
and potency of biological products and
to ensure that the biologics licenses for
such products are only issued when a
product meets the prescribed standards.
Under § 610.2 (21 CFR 610.2), the
Center for Biologics Evaluation and
Research (CBER) or the Center for Drug
Evaluation and Research may at any
time require manufacturers of licensed
biological products to submit to FDA
samples of any lot along with the
protocols showing the results of
applicable tests prior to distributing the
lot of the product. In addition to § 610.2,
there are other regulations that require
the submission of samples and protocols
for specific licensed biological products:
§§ 660.6 (21 CFR 660.6) (Antibody to
Hepatitis B Surface Antigen); 660.36 (21
CFR 660.36) (Reagent Red Blood Cells);
and 660.46 (21 CFR 660.46) (Hepatitis B
Surface Antigen).
Section 660.6(a) provides
requirements for the frequency of
submission of samples from each lot of
Antibody to Hepatitis B Surface Antigen
product, and § 660.6(b) provides the
requirements for the submission of a
protocol containing specific information
along with each required sample. For
§ 660.6 products subject to official
release by FDA, one sample from each
filling of each lot is required to be
submitted along with a protocol
consisting of a summary of the history
of manufacture of the product,
including all results of each test for
which test results are requested by
CBER. After official release is no longer
required, one sample along with a
protocol is required to be submitted at
90-day intervals. In addition, samples,
which must be accompanied by a
protocol, may at any time be required to
be submitted to CBER if continued
evaluation is deemed necessary.
Section 660.36(a) requires, after each
routine establishment inspection by
FDA, the submission of samples from a
lot of final Reagent Red Blood Cell
product along with a protocol
containing specific information. Section
660.36(a)(2) requires that a protocol
contain information including, but not
limited to, manufacturing records,
certain test records, and identity test
results. Section 660.36(b) requires a
copy of the antigenic constitution
matrix specifying the antigens present
or absent to be submitted to the CBER
Director at the time of initial
distribution of each lot.
Section 660.46(a) contains
requirements as to the frequency of
submission of samples from each lot of
Hepatitis B Surface Antigen product,
and § 660.46(b) contains the
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Fmt 4703
Sfmt 4703
9821
requirements as to the submission of a
protocol containing specific information
along with each required sample. For
§ 660.46 products subject to official
release by FDA, one sample from each
filling of each lot is required to be
submitted along with a protocol
consisting of a summary of the history
of manufacture of the product,
including all results of each test for
which test results are requested by
CBER. After notification of official
release is received, one sample along
with a protocol is required to be
submitted at 90-day intervals. In
addition, samples, which must be
accompanied by a protocol, may at any
time be required to be submitted to
CBER if continued evaluation is deemed
necessary.
Samples and protocols are required by
FDA to help ensure the safety, purity, or
potency of a product because of the
potential lot-to-lot variability of a
product produced from living
organisms. In cases of certain biological
products (e.g., Albumin, Plasma Protein
Fraction, and therapeutic biological
products) that are known to have lot-tolot consistency, official lot release is not
normally required. However,
submissions of samples and protocols of
these products may still be required for
surveillance, licensing, and export
purposes, or in the event that FDA
obtains information that the
manufacturing process may not result in
consistent quality of the product.
The following burden estimate is for
the protocols required to be submitted
with each sample. The collection of
samples is not a collection of
information under 5 CFR 1320.3(h)(2).
Respondents to the collection of
information under § 610.2 are
manufacturers of licensed biological
products. Respondents to the collection
of information under §§ 660.6(b),
660.36(a)(2) and (b), and 660.46(b) are
manufacturers of the specific products
referenced previously in this document.
The estimated number of respondents
for each regulation is based on the
annual number of manufacturers that
submitted samples and protocols for
biological products including
submissions for lot release, surveillance,
licensing, or export. Based on
information obtained from FDA’s
database system, approximately 69
manufacturers submitted samples and
protocols in fiscal year (FY) 2008, under
the regulations cited previously in this
document. FDA estimates that
approximately 65 manufacturers
submitted protocols under § 610.2 and 3
manufacturers submitted protocols
under the regulations (§§ 660.6 and
660.46) for the other specific products.
E:\FR\FM\06MRN1.SGM
06MRN1
9822
Federal Register / Vol. 74, No. 43 / Friday, March 6, 2009 / Notices
FDA received no submissions under
§ 660.36, however FDA is using the
estimate of one protocol submission in
the event one is submitted in the future.
The estimated total annual responses
are based on FDA’s final actions
completed in FY 2008, which totaled
6,314, for the various submission
requirements of samples and protocols
for the licensed biological products. The
rate of final actions is not expected to
change significantly in the next few
years. The hours per response are based
on information provided by industry.
The burden estimates provided by
industry ranged from 1 to 5.5 hours.
Under § 610.2, the hours per response
are based on the average of these
estimates and rounded to 3 hours.
Under the remaining regulations, the
hours per response are based on the
higher end of the estimate (rounded to
5 or 6 hours) since more information is
generally required to be submitted in
the other protocols than under § 610.2.
FDA estimates the burden of this
information collection as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
No. of
Respondents
21 CFR Section
610.2
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total Hours
65
95.5
6,208
3
18,624
660.6(b)
2
44
88
5
440
660.36(a)(2) and (b)
1
1
1
6
6
660.46(b)
1
17
17
5
85
Total
69
1 There
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0083]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Gluten-Free
Labeling of Food Products
Experimental Study
Food and Drug Administration,
HHS.
mstockstill on PROD1PC66 with NOTICES
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 and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
a voluntary consumer study entitled
‘‘Gluten-Free Labeling of Food Products
Experimental Study.’’
DATES: Submit written or electronic
comments on the collection of
information by May 5, 2009.
VerDate Nov<24>2008
16:20 Mar 05, 2009
Jkt 217001
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:
Jonna Capezzuto, Office of Information
Management (HFA–710), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–796–3794.
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
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
ADDRESSES:
BILLING CODE 4160–01–S
ACTION:
19,155
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: February 24, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E9–4750 Filed 3–5–09; 8:45 am]
AGENCY:
6,314
PO 00000
Frm 00044
Fmt 4703
Sfmt 4703
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.
Gluten-Free Labeling of Food Products
Experimental Study
Under section 903(b)(2) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
393(b)(2)), FDA is authorized to conduct
research relating to foods and to
conduct educational and public
information programs relating to the
safety of the nation’s food supply. FDA
is planning to conduct an experimental
study about gluten-free labeling of food
products. The Gluten-Free Labeling of
Food Products Experimental Study will
collect information from both
consumers who have celiac disease or
gluten intolerance and those who do not
have either condition. The purpose of
the study is to gauge perceptions of
characteristics related to claims of
‘‘gluten-free’’ and allowed variants (e.g.,
‘‘free of gluten,’’ ‘‘without gluten,’’ ‘‘no
gluten’’), in addition to other types of
statements (e.g., ‘‘made in a gluten-free
facility’’ or ‘‘not made in a facility that
processes gluten-containing foods’’) on
the food label. The study will also
E:\FR\FM\06MRN1.SGM
06MRN1
]]>Agencies
[Federal Register Volume 74, Number 43 (Friday, March 6, 2009)]
[Notices]
[Pages 9820-9822]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-4750]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0097]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Request for Samples and Protocols
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 the information collection
requirements relating to the regulations which state that protocols for
samples of biological products must be submitted to the agency.
DATES: Submit written or electronic comments on the collection of
information by May 5, 2009.
[[Page 9821]]
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: Jonna Capezzuto, Office of Information
Management (HFA-710), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-796-3794.
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.
Request for Samples and Protocols (OMB Control Number 0910-0206)--
Extension
Under section 351 of the Public Health Service Act (42 U.S.C. 262),
FDA has the responsibility to issue regulations that prescribe
standards designed to ensure the safety, purity, and potency of
biological products and to ensure that the biologics licenses for such
products are only issued when a product meets the prescribed standards.
Under Sec. 610.2 (21 CFR 610.2), the Center for Biologics Evaluation
and Research (CBER) or the Center for Drug Evaluation and Research may
at any time require manufacturers of licensed biological products to
submit to FDA samples of any lot along with the protocols showing the
results of applicable tests prior to distributing the lot of the
product. In addition to Sec. 610.2, there are other regulations that
require the submission of samples and protocols for specific licensed
biological products: Sec. Sec. 660.6 (21 CFR 660.6) (Antibody to
Hepatitis B Surface Antigen); 660.36 (21 CFR 660.36) (Reagent Red Blood
Cells); and 660.46 (21 CFR 660.46) (Hepatitis B Surface Antigen).
Section 660.6(a) provides requirements for the frequency of
submission of samples from each lot of Antibody to Hepatitis B Surface
Antigen product, and Sec. 660.6(b) provides the requirements for the
submission of a protocol containing specific information along with
each required sample. For Sec. 660.6 products subject to official
release by FDA, one sample from each filling of each lot is required to
be submitted along with a protocol consisting of a summary of the
history of manufacture of the product, including all results of each
test for which test results are requested by CBER. After official
release is no longer required, one sample along with a protocol is
required to be submitted at 90-day intervals. In addition, samples,
which must be accompanied by a protocol, may at any time be required to
be submitted to CBER if continued evaluation is deemed necessary.
Section 660.36(a) requires, after each routine establishment
inspection by FDA, the submission of samples from a lot of final
Reagent Red Blood Cell product along with a protocol containing
specific information. Section 660.36(a)(2) requires that a protocol
contain information including, but not limited to, manufacturing
records, certain test records, and identity test results. Section
660.36(b) requires a copy of the antigenic constitution matrix
specifying the antigens present or absent to be submitted to the CBER
Director at the time of initial distribution of each lot.
Section 660.46(a) contains requirements as to the frequency of
submission of samples from each lot of Hepatitis B Surface Antigen
product, and Sec. 660.46(b) contains the requirements as to the
submission of a protocol containing specific information along with
each required sample. For Sec. 660.46 products subject to official
release by FDA, one sample from each filling of each lot is required to
be submitted along with a protocol consisting of a summary of the
history of manufacture of the product, including all results of each
test for which test results are requested by CBER. After notification
of official release is received, one sample along with a protocol is
required to be submitted at 90-day intervals. In addition, samples,
which must be accompanied by a protocol, may at any time be required to
be submitted to CBER if continued evaluation is deemed necessary.
Samples and protocols are required by FDA to help ensure the
safety, purity, or potency of a product because of the potential lot-
to-lot variability of a product produced from living organisms. In
cases of certain biological products (e.g., Albumin, Plasma Protein
Fraction, and therapeutic biological products) that are known to have
lot-to-lot consistency, official lot release is not normally required.
However, submissions of samples and protocols of these products may
still be required for surveillance, licensing, and export purposes, or
in the event that FDA obtains information that the manufacturing
process may not result in consistent quality of the product.
The following burden estimate is for the protocols required to be
submitted with each sample. The collection of samples is not a
collection of information under 5 CFR 1320.3(h)(2). Respondents to the
collection of information under Sec. 610.2 are manufacturers of
licensed biological products. Respondents to the collection of
information under Sec. Sec. 660.6(b), 660.36(a)(2) and (b), and
660.46(b) are manufacturers of the specific products referenced
previously in this document. The estimated number of respondents for
each regulation is based on the annual number of manufacturers that
submitted samples and protocols for biological products including
submissions for lot release, surveillance, licensing, or export. Based
on information obtained from FDA's database system, approximately 69
manufacturers submitted samples and protocols in fiscal year (FY) 2008,
under the regulations cited previously in this document. FDA estimates
that approximately 65 manufacturers submitted protocols under Sec.
610.2 and 3 manufacturers submitted protocols under the regulations
(Sec. Sec. 660.6 and 660.46) for the other specific products.
[[Page 9822]]
FDA received no submissions under Sec. 660.36, however FDA is using
the estimate of one protocol submission in the event one is submitted
in the future.
The estimated total annual responses are based on FDA's final
actions completed in FY 2008, which totaled 6,314, for the various
submission requirements of samples and protocols for the licensed
biological products. The rate of final actions is not expected to
change significantly in the next few years. The hours per response are
based on information provided by industry. The burden estimates
provided by industry ranged from 1 to 5.5 hours. Under Sec. 610.2, the
hours per response are based on the average of these estimates and
rounded to 3 hours. Under the remaining regulations, the hours per
response are based on the higher end of the estimate (rounded to 5 or 6
hours) since more information is generally required to be submitted in
the other protocols than under Sec. 610.2.
FDA estimates the burden of this information collection as follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual Hours per
21 CFR Section Respondents per Response Responses Response Total Hours
----------------------------------------------------------------------------------------------------------------
610.2 65 95.5 6,208 3 18,624
----------------------------------------------------------------------------------------------------------------
660.6(b) 2 44 88 5 440
----------------------------------------------------------------------------------------------------------------
660.36(a)(2) and 1 1 1 6 6
(b)
----------------------------------------------------------------------------------------------------------------
660.46(b) 1 17 17 5 85
----------------------------------------------------------------------------------------------------------------
Total 69 ................. 6,314 ................. 19,155
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Dated: February 24, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-4750 Filed 3-5-09; 8:45 am]
BILLING CODE 4160-01-S
