Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Request for Samples and Protocols, 41408-41410 [2012-17079]
Download as PDF
<![CDATA[
41408
Federal Register / Vol. 77, No. 135 / Friday, July 13, 2012 / Notices
srobinson on DSK4SPTVN1PROD with NOTICES
testing strategies proposed for
identifying eye injury hazard potential
of chemicals and products. If available,
in vivo reference data for substances
tested in these data sets are also
requested. Although data can be
accepted at any time, please submit data
by August 27, 2012 to ensure
consideration during the ICCVAM
evaluation process. Relevant data
received after this date will be
considered where feasible. All
information submitted in response to
this notice will be made publicly
available and may be incorporated into
future NICEATM and ICCVAM reports
and publications, as appropriate.
When submitting data, please
reference this Federal Register notice
and provide appropriate contact
information (name, affiliation, mailing
address, phone, fax, email, and
sponsoring organization, as applicable).
NICEATM prefers that data be
submitted as copies of pages from study
notebooks and/or study reports, if
available. Laboratory data and analyses
available in electronic format may also
be submitted. Each submission for a
substance should preferably include the
following information, as appropriate:
common and trade name, Chemical
Abstracts Service Registry Number
(CASRN), commercial source, in vitro
test protocol used, rabbit eye test
protocol used, individual animal or in
vitro responses at each observation time
(i.e., raw data), extent to which the data
were collected in accordance with
national or international Good
Laboratory Practice guidelines, date and
testing organization, and physical and
chemical properties (e.g., molecular
weight, pH, water solubility, etc.)
Background Information on ICCVAM
and NICEATM
ICCVAM is an interagency committee
composed of representatives from 15
Federal regulatory and research agencies
that require, use, generate, or
disseminate toxicological and safety
testing information. ICCVAM conducts
technical evaluations of new, revised,
and alternative safety testing methods
and integrated testing strategies with
regulatory applicability and promotes
the scientific validation and regulatory
acceptance of testing methods that more
accurately assess the safety and hazards
of chemicals and products and that
reduce, refine (enhance animal wellbeing and lessen or avoid pain and
distress), or replace animal use. The
ICCVAM Authorization Act of 2000 (42
U.S.C. 285l–3) established ICCVAM as a
permanent interagency committee of the
NIEHS under NICEATM. NICEATM
administers ICCVAM, provides
VerDate Mar<15>2010
17:08 Jul 12, 2012
Jkt 226001
scientific and operational support for
ICCVAM-related activities, and
conducts independent validation
studies to assess the usefulness and
limitations of new, revised, and
alternative test methods and strategies.
NICEATM and ICCVAM welcome the
public nomination of new, revised, and
alternative test methods and strategies
for validation studies and technical
evaluations. Additional information
about NICEATM and ICCVAM can be
found on the NICEATM–ICCVAM Web
site (https://iccvam.niehs.nih.gov).
References
ICCVAM. 2006. ICCVAM Test Method
Evaluation Report: In Vitro Ocular
Toxicity Test Methods for Identifying
Severe Irritants and Corrosives. NIH
Publication No. 07–4517. Research
Triangle Park, NC: NIEHS. Available:
https://iccvam.niehs.nih.gov/methods/
ocutox/ivocutox/ocu_tmer.htm.
ICCVAM. 2008. The NICEATM–
ICCVAM Five-Year Plan (2008–2012): A
Plan to Advance Alternative Test
Methods of High Scientific Quality to
Protect and Advance the Health of
People, Animals, and the Environment.
NIH Publication No. 08–6410. Research
Triangle Park, NC: NIEHS. Available:
https://iccvam.niehs.nih.gov/docs/
5yearplan.htm.
ICCVAM. 2010a. ICCVAM Test
Method Evaluation Report: Current
Validation Status of In Vitro Test
Methods Proposed for Identifying Eye
Injury Hazard Potential of Chemicals
and Products. NIH Publication No. 10–
7553. Research Triangle Park, NC:
NIEHS. Available: https://
iccvam.niehs.nih.gov/methods/ocutox/
MildMod-TMER.htm.
ICCVAM. 2010b. ICCVAM Test
Method Evaluation Report: Current
Validation Status of a Proposed In Vitro
Testing Strategy for U.S. Environmental
Protection Agency Ocular Hazard
Classification and Labeling of
Antimicrobial Cleaning Products. NIH
Publication No. 10–7513. Research
Triangle Park, NC: NIEHS. Available:
https://iccvam.niehs.nih.gov/methods/
ocutox/antimicro/TMER.htm.
OECD. 2009a. Test Guideline 437.
Bovine Corneal Opacity and
Permeability Test Method for
Identifying Ocular Corrosives and
Severe Irritants [adopted 7 September
2009]. In: OECD Guidelines for the
Testing of Chemicals, Section 4: Health
Effects. Paris:OECD Publishing.
Available: https://www.oecd-ilibrary.org/
environment/test-no-437-bovinecorneal-opacity-and-permeability-testmethod-for-identifying-ocularcorrosives-and-severeirritants_9789264076303-en.
PO 00000
Frm 00059
Fmt 4703
Sfmt 4703
OECD. 2009b. Test No. 438. Isolated
Chicken Eye Test Method for Identifying
Ocular Corrosives and Severe Irritants
[adopted 7 September 2009]. In: OECD
Guidelines for Testing of Chemicals.
Paris:OECD Publishing. Available:
https://www.oecd-ilibrary.org/
environment/test-no-438-isolatedchicken-eye-test-method-for-identifyingocular-corrosives-and-severeirritants_9789264076310-en.
Takahashi Y, Koike M, Honda H, Ito Y,
Sakaguchi H, Suzuki H, Nishiyama
N. 2008. Development of the short
time exposure (STE) test: an in vitro
eye irritation test using SIRC cells.
Toxicol In Vitro 22:760–770.
Dated: July 5, 2012.
John R. Bucher,
Associate Director, National Toxicology
Program.
[FR Doc. 2012–17118 Filed 7–12–12; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0114]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Request for
Samples and Protocols
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.
DATES: Fax written comments on the
collection of information by August 13,
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 0910–0206. Also
include the FDA docket number found
in brackets in the heading of this
document.
SUMMARY:
Ila
S. Mizrachi, Food and Drug
Administration, 1350 Piccard Dr., PI50–
FOR FURTHER INFORMATION CONTACT:
E:\FR\FM\13JYN1.SGM
13JYN1
Federal Register / Vol. 77, No. 135 / Friday, July 13, 2012 / Notices
srobinson on DSK4SPTVN1PROD with NOTICES
400B, Rockville, MD 20850, 301–796–
7726, Ila.Mizrachi@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
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 § 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.
VerDate Mar<15>2010
17:08 Jul 12, 2012
Jkt 226001
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
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
PO 00000
Frm 00060
Fmt 4703
Sfmt 4703
41409
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 77
manufacturers submitted samples and
protocols in fiscal year (FY) 2011, under
the regulations cited previously in this
document. FDA estimates that
approximately 73 manufacturers
submitted protocols under § 610.2 and 2
manufacturers submitted protocols
under the regulation (§ 660.6) for the
other specific product. FDA received no
submissions under § 660.36 or § 660.46;
however, FDA is using the estimate of
one protocol submission under each
regulation in the event that protocols are
submitted in the future.
The estimated total annual responses
are based on FDA’s final actions
completed in FY 2011 for the various
submission requirements of samples
and protocols for the licensed biological
products. The average burden per
response is based on information
provided by industry. The burden
estimates provided by industry ranged
from 1 to 5.5 hours. Under § 610.2, the
average burden per response is based on
the average of these estimates and
rounded to 3 hours. Under the
remaining regulations, the average
burden per response is 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.
In the Federal Register of February
17, 2012 (77 FR 9663), FDA published
a 60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
information collection as follows:
E:\FR\FM\13JYN1.SGM
13JYN1
41410
Federal Register / Vol. 77, No. 135 / Friday, July 13, 2012 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
21 CFR Section
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
610.2 ....................................................................................
660.6(b) ................................................................................
660.36(a) (2) and (b) ...........................................................
660.46(b) ..............................................................................
73
2
1
1
92.9
21.5
1
1
6,782
43
1
1
3
5
6
5
20,346
215
6
5
Total ..............................................................................
77
........................
6,827
........................
20,572
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: July 6, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
7726, Ila.Mizrachi@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
[FR Doc. 2012–17079 Filed 7–12–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0115]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request: Guidance for
Industry and Food and Drug
Administration Staff; Class II Special
Controls Guidance Document;
Automated Blood Cell Separator
Device Operating by Centrifugal or
Filtration Separation Principle
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.
DATES: Fax written comments on the
collection of information by August 13,
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 0910–0594. Also
include the FDA docket number found
in brackets in the heading of this
document.
srobinson on DSK4SPTVN1PROD with NOTICES
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
S. Mizrachi, Office of Information
Management, Food and Drug
VerDate Mar<15>2010
17:08 Jul 12, 2012
Jkt 226001
Ila
Guidance for Industry and Food and
Drug Administration Staff; Class II
Special Controls Guidance Document:
Automated Blood Cell Separator Device
Operating by Centrifugal or Filtration
Separation Principle (OMB Control
Number 0910–0594)—Extension
Under the Safe Medical Devices Act
of 1990 (Pub. L. 101–629), FDA may
establish special controls, including
performance standards, postmarket
surveillance, patient registries,
guidelines, and other appropriate
actions it believes necessary to provide
reasonable assurance of the safety and
effectiveness of the device.
The special control guidance serves to
support the reclassification from class
III to class II of the automated blood cell
separator device operating on a
centrifugal separation principle
intended for the routine collection of
blood and blood components as well as
the special control for the automated
blood cell separator device operating on
a filtration separation principle
intended for the routine collection of
blood and blood components
reclassified as class II (§ 864.9245 (21
CFR 864.9245)).
For currently marketed products not
approved under the premarket approval
process, the manufacturer should file
with FDA for 3 consecutive years an
annual report on the anniversary date of
the device reclassification from class III
to class II or, on the anniversary date of
the 510(k) of the Federal Food, Drug,
and Cosmetic Act (the FD&C Act) (21
U.S.C. 360) clearance. Any subsequent
change to the device requiring the
submission of a premarket notification
in accordance with section 510(k) of the
FD&C Act should be included in the
annual report. Also, a manufacturer of a
PO 00000
Frm 00061
Fmt 4703
Sfmt 4703
device determined to be substantially
equivalent to the centrifugal or
filtration-based automated cell separator
device intended for the routine
collection of blood and blood
components, should comply with the
same general and special controls.
The annual report should include, at
a minimum, a summary of anticipated
and unanticipated adverse events that
have occurred and that are not required
to be reported by manufacturers under
Medical Device Reporting (MDR) (part
803 (21 CFR part 803)). The reporting of
adverse device events summarized in an
annual report will alert FDA to trends
or clusters of events that might be a
safety issue otherwise unreported under
the MDR regulation.
Reclassification of this device from
class III to class II for the intended use
of routine collection of blood and blood
components relieves manufacturers of
the burden of complying with the
premarket approval requirements of
section 515 of the FD&C Act (21 U.S.C.
360e), and may permit small potential
competitors to enter the marketplace by
reducing the burden. Although the
special control guidance recommends
that manufacturers of these devices file
with FDA an annual report for 3
consecutive years, this would be less
burdensome than the current
postapproval requirements under part
814, subpart E (21 CFR part 814, subpart
E), including the submission of periodic
reports under § 814.84.
Collecting or transfusing facilities,
and manufacturers have certain
responsibilities under the Federal
regulations. For example, collecting or
transfusing facilities are required to
maintain records of any reports of
complaints of adverse reactions (21 CFR
606.170), while the manufacturer is
responsible for conducting an
investigation of each event that is
reasonably known to the manufacturer
and evaluating the cause of the event
(§ 803.50(b)). In addition, manufacturers
of medical devices are required to
submit to FDA individual adverse event
E:\FR\FM\13JYN1.SGM
13JYN1
]]>Agencies
[Federal Register Volume 77, Number 135 (Friday, July 13, 2012)]
[Notices]
[Pages 41408-41410]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-17079]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0114]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Request for Samples
and Protocols
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.
DATES: Fax written comments on the collection of information by August
13, 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 0910-0206.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Food and Drug
Administration, 1350 Piccard Dr., PI50-
[[Page 41409]]
400B, Rockville, MD 20850, 301-796-7726, Ila.Mizrachi@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
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 77
manufacturers submitted samples and protocols in fiscal year (FY) 2011,
under the regulations cited previously in this document. FDA estimates
that approximately 73 manufacturers submitted protocols under Sec.
610.2 and 2 manufacturers submitted protocols under the regulation
(Sec. 660.6) for the other specific product. FDA received no
submissions under Sec. 660.36 or Sec. 660.46; however, FDA is using
the estimate of one protocol submission under each regulation in the
event that protocols are submitted in the future.
The estimated total annual responses are based on FDA's final
actions completed in FY 2011 for the various submission requirements of
samples and protocols for the licensed biological products. The average
burden per response is based on information provided by industry. The
burden estimates provided by industry ranged from 1 to 5.5 hours. Under
Sec. 610.2, the average burden per response is based on the average of
these estimates and rounded to 3 hours. Under the remaining
regulations, the average burden per response is 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.
In the Federal Register of February 17, 2012 (77 FR 9663), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
FDA estimates the burden of this information collection as follows:
[[Page 41410]]
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
21 CFR Section Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
610.2........................... 73 92.9 6,782 3 20,346
660.6(b)........................ 2 21.5 43 5 215
660.36(a) (2) and (b)........... 1 1 1 6 6
660.46(b)....................... 1 1 1 5 5
-------------------------------------------------------------------------------
Total....................... 77 .............. 6,827 .............. 20,572
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Dated: July 6, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-17079 Filed 7-12-12; 8:45 am]
BILLING CODE 4160-01-P
