Agency Information Collection Activities; Proposed Collection; Comment Request; Request for Samples and Protocols, 16393-16395 [2015-07008]
Download as PDF
<![CDATA[
16393
Federal Register / Vol. 80, No. 59 / Friday, March 27, 2015 / Notices
A contractor will also collect assault
injury data from nursing home violent
event reports three years pre-regulation
(2009–2011) and three years postregulation (2012–2014). This data will
be collected from existing OSHA logs; a
NIOSH employee will fill out the
Employee Incident Form from the
OSHA logs received from the contractor.
The purpose of collecting these data is
to evaluate changes in assault injury
rates before and after enactment of the
regulations (Aim 2). The following
information will be abstracted from the
OSHA logs: Date, time and location of
the incident; identity, job title and job
task of the victim; identity of the
perpetrator; description of the violent
act, including whether a weapon was
used; description of physical injuries;
number of employees in the vicinity
when the incident occurred, and their
actions in response to the incident;
recommendations of police advisors,
employees or consultants, and; actions
taken by the facility in response to the
incident. No employee or perpetrator
identifiable information will be
collected.
There are no costs to respondents
other than their time. The total
estimated burden hours are 120.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Average
burden per
esponse
(in hours)
Number of
responses per
respondent
Total burden
(in hours)
Type of respondents
Form name
Nursing Home Administrator ..................
Nursing Home Administrator ..................
Nursing Home Administrator ..................
Interview ......................................
Abstraction Form .........................
Employee Incident Form .............
40
40
40
1
1
1
1
1
1
40
40
40
Total ................................................
.....................................................
........................
........................
........................
120
Leroy A. Richardson,
Chief, Information Collection Review Office,
Office of Scientific Integrity, Office of the
Associate Director for Science, Office of the
Director, Centers for Disease Control and
Prevention.
Dated: March 20, 2015.
Francis S. Collins,
Director, NIH.
[FR Doc. 2015–07064 Filed 3–26–15; 8:45 am]
BILLING CODE 4140–01–P
[FR Doc. 2015–07038 Filed 3–26–15; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0114]
mstockstill on DSK4VPTVN1PROD with NOTICES
National Institutes of Health Statement
of Organization, Functions, and
Delegations of Authority
Part N, National Institutes of Health
(NIH), of the Statement of Organization,
Functions, and Delegations of Authority
for the Department of Health and
Human Services (40 FR 22859, May 27,
1975, as amended most recently at 77
FR 1941, January 12, 2012, and
redesignated from Part HN as Part N at
60 FR 56605, November 9, 1995), is
amended as set forth below to rename
the National Center for Complementary
and Alternative Medicine (NCCAM).
Section N–D, Organization and
Functions, under the heading National
Center for Complementary and
Alternative Medicine (NCCAM), is
renamed to the National Center for
Complementary and Integrative Health
(NCCIH).
Delegations of Authority Statement:
All delegations and redelegations of
authority to officers and employees of
NIH that were in effect immediately
prior to the effective date of this
reorganization and are consistent with
this reorganization shall continue in
effect, pending further redelegation.
VerDate Sep<11>2014
20:59 Mar 26, 2015
Jkt 235001
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Request for
Samples and Protocols
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
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 either electronic or
written comments on the collection of
information by May 26, 2015.
Frm 00035
Fmt 4703
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
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.
SUPPLEMENTARY INFORMATION:
Notice.
SUMMARY:
PO 00000
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.
ADDRESSES:
Sfmt 4703
E:\FR\FM\27MRN1.SGM
27MRN1
16394
Federal Register / Vol. 80, No. 59 / Friday, March 27, 2015 / Notices
mstockstill on DSK4VPTVN1PROD with NOTICES
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 21 CFR 610.2, the Center for
Biologics Evaluation and Research
(CBER) or the Center for Drugs
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:
21 CFR 660.6 (Antibody to Hepatitis B
Surface Antigen); 21 CFR 660.36
(Reagent Red Blood Cells); and 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,
VerDate Sep<11>2014
20:59 Mar 26, 2015
Jkt 235001
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
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
PO 00000
Frm 00036
Fmt 4703
Sfmt 4703
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 80
manufacturers submitted samples and
protocols in fiscal year (FY) 2014, under
the regulations cited previously in this
document. FDA estimates that
approximately 76 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 2014 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.
FDA estimates the burden of this
information collection as follows:
E:\FR\FM\27MRN1.SGM
27MRN1
16395
Federal Register / Vol. 80, No. 59 / Friday, March 27, 2015 / 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 Lot Release Information Submission ....................................
660.6(b) Lot Release Information Submission ................................
660.36(a)(2) and (b) Lot Release Information Submission .............
660.46(b) Lot Release Information Submission ..............................
76
2
1
1
84.54
9
1
1
6,197
18
1
1
3
5
6
5
18,591
90
6
5
Total ............................................................................................
80
..........................
6,217
....................
18,692
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: March 23, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–07008 Filed 3–26–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–3313–N]
Announcement of the Re-Approval of
the College of American Pathologists
(CAP) as an Accreditation Organization
Under the Clinical Laboratory
Improvement Amendments of 1988
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Notice.
AGENCY:
This notice announces the
application of the College of American
Pathologists (CAP) for approval as an
accreditation organization for clinical
laboratories under the Clinical
Laboratory Improvement Amendments
of 1988 (CLIA) program. We have
determined that the CAP meets or
exceeds the applicable CLIA
requirements. In this notice, we
announce the approval and grant CAP
deeming authority for a period of 6
years.
SUMMARY:
This notice is effective from
March 27, 2015, until March 27, 2021.
FOR FURTHER INFORMATION CONTACT:
Melissa Singer, 410–786–0365.
SUPPLEMENTARY INFORMATION:
DATES:
mstockstill on DSK4VPTVN1PROD with NOTICES
I. Background and Legislative
Authority
On October 31, 1988, the Congress
enacted the Clinical Laboratory
Improvement Amendments of 1988
(CLIA) (Pub. L. 100–578). CLIA
amended section 353 of the Public
Health Service Act. We issued a final
rule implementing the accreditation
provisions of CLIA on July 31, 1992 (57
FR 33992). Under these provisions, we
VerDate Sep<11>2014
20:59 Mar 26, 2015
Jkt 235001
may grant deeming authority to an
accreditation organization if its
requirements for laboratories accredited
under its program are equal to or more
stringent than the applicable CLIA
program requirements in 42 CFR part
493 (Laboratory Requirements). Subpart
E of part 493 (Accreditation by a Private,
Nonprofit Accreditation Organization or
Exemption under an Approved State
Laboratory Program) specifies the
requirements an accreditation
organization must meet to be approved
by CMS as an accreditation organization
under CLIA.
II. Notice of Approval of CAP as an
Accreditation Organization
In this notice, we approve the College
of American Pathologists (CAP) as an
organization that may accredit
laboratories for purposes of establishing
their compliance with CLIA
requirements in all specialties and
subspecialties. We have examined the
initial CAP application and all
subsequent submissions to determine its
accreditation program’s equivalency
with the requirements for approval of an
accreditation organization under
subpart E of part 493. We have
determined that the CAP meets or
exceeds the applicable CLIA
requirements. We have also determined
that the CAP will ensure that its
accredited laboratories will meet or
exceed the applicable requirements in
subparts H, I, J, K, M, Q, and the
applicable sections of R. Therefore, we
grant the CAP approval as an
accreditation organization under
subpart E of part 493, for the period
stated in the DATES section of this notice
for all specialties and subspecialties
areas under CLIA. As a result of this
determination, any laboratory that is
accredited by the CAP during the time
period stated in the DATES section of this
notice will be deemed to meet the CLIA
requirements for the listed specialties
and subspecialties, and therefore, will
generally not be subject to routine
inspections by a state survey agency to
determine its compliance with CLIA
PO 00000
Frm 00037
Fmt 4703
Sfmt 4703
requirements. The accredited laboratory,
however, is subject to validation and
complaint investigation surveys
performed by CMS, or its agent(s).
III. Evaluation of the CAP Request for
Approval as an Accreditation
Organization Under CLIA
The following describes the process
used to determine that the CAP
accreditation program meets the
necessary requirements to be approved
by CMS as an accreditation program
with deeming authority under the CLIA
program. The CAP formally applied to
CMS for approval as an accreditation
organization under CLIA for all
specialties and subspecialties. In
reviewing these materials, we reached
the following determinations for each
applicable part of the CLIA regulations:
A. Subpart E—Accreditation by a
Private, Nonprofit Accreditation
Organization or Exemption Under an
Approved State Laboratory Program
The CAP submitted its mechanism for
monitoring compliance with all
requirements equivalent to conditionlevel requirements, a list of all its
current laboratories and the expiration
date of their accreditation, and a
detailed comparison of the individual
accreditation requirements with the
comparable condition-level
requirements. We have determined that
the CAP’s policies and procedures for
oversight of laboratories performing all
laboratory testing covered by CLIA are
equivalent to those required by our
CLIA regulations in the matters of
inspection, monitoring proficiency
testing (PT) performance, investigating
complaints, and making PT information
available. The CAP submitted
documentation regarding its
requirements for monitoring and
inspecting laboratories, and describing
its own standards regarding
accreditation removal or withdrawal of
accreditation, notification requirements,
and accreditation organization
resources. We have determined that the
requirements of the accreditation
program submitted for approval are
E:\FR\FM\27MRN1.SGM
27MRN1
]]>Agencies
[Federal Register Volume 80, Number 59 (Friday, March 27, 2015)]
[Notices]
[Pages 16393-16395]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-07008]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0114]
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 either electronic or written comments on the collection
of information by May 26, 2015.
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: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002, PRAStaff@fda.hhs.gov.
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.
[[Page 16394]]
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 21 CFR 610.2, the Center for Biologics Evaluation and Research
(CBER) or the Center for Drugs 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: 21 CFR 660.6 (Antibody to Hepatitis B Surface Antigen); 21
CFR 660.36 (Reagent Red Blood Cells); and 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 80
manufacturers submitted samples and protocols in fiscal year (FY) 2014,
under the regulations cited previously in this document. FDA estimates
that approximately 76 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 2014 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. FDA estimates the burden of this information collection as
follows:
[[Page 16395]]
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Total Average
21 CFR section Number of responses per annual burden per Total hours
respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
610.2 Lot Release Information Submission.... 76 84.54 6,197 3 18,591
660.6(b) Lot Release Information Submission. 2 9 18 5 90
660.36(a)(2) and (b) Lot Release Information 1 1 1 6 6
Submission.................................
660.46(b) Lot Release Information Submission 1 1 1 5 5
-------------------------------------------------------------------
Total................................... 80 .............. 6,217 ........... 18,692
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Dated: March 23, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-07008 Filed 3-26-15; 8:45 am]
BILLING CODE 4164-01-P
