Draft Guidance for Industry on Use of Histology in Biomarker Qualification Studies; Availability, 82306-82308 [2011-33553]
Download as PDF
82306
Federal Register / Vol. 76, No. 251 / Friday, December 30, 2011 / Notices
document for non-public responses to
unsolicited requests).
2. Representatives who provide public
responses to unsolicited requests for offlabel information should clearly
disclose their involvement with a
particular firm.
3. Public responses to public
unsolicited requests for off-label
information should not be promotional
in nature or tone and should include a
mechanism for providing readily
accessible FDA-required labeling, if any,
for the product (e.g., FDA-approved
package insert and, if the response is for
a consumer, FDA-approved patient
labeling or, for new animal drugs, FDAapproved client information sheet).
FDA estimates that approximately 400
firms respond annually to
approximately 40,000 non-public
unsolicited requests for off-label
information made directly and privately
to them as well as to public unsolicited
requests for off-label information,
including those that firms may
encounter on emerging electronic
media. FDA estimates that it will take
firms approximately 4 hours to provide
responses to each unsolicited request for
off-label information as recommended
in the draft guidance.
FDA also estimates that
approximately 40,000 records will be
maintained for all responses to nonpublic and public unsolicited requests
for off-label information, and that each
record will take approximately 15
minutes to prepare and maintain.
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Draft guidance on responding to unsolicited
requests for off-label information
Number of
respondents
Responses to non-public and public unsolicited requests .....................................................................
1 There
Number of
responses per
respondent
400
Total annual
responses
100
Average burden
per response
40,000
4
Total hours
160,000
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Draft guidance on responding to unsolicited
requests for off-label information
Number of
recordkeepers
Records related to responses to non-public and
public unsolicited requests .....................................
1 There
400
Total annual
records
100
Average
burden per
recordkeeping
40,000
.25
Total hours
10,000
are no capital costs or operating and maintenance costs associated with this collection of information.
III. Comments
Interested persons can submit to the
Division of Dockets Management (see
ADDRESSES) either electronic or written
comments regarding this document. It is
only necessary to send one set of
comments. It is no longer necessary to
send two copies of mailed comments.
Identify comments with the docket
number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
IV. Electronic Access
19:02 Dec 29, 2011
Jkt 226001
[FR Doc. 2011–33550 Filed 12–29–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–D–0872]
Draft Guidance for Industry on Use of
Histology in Biomarker Qualification
Studies; Availability
Food and Drug Administration,
HHS.
ACTION:
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm,
https://www.fda.gov/BiologicsBlood
Vaccines/GuidanceCompliance
RegulatoryInformation/default.htm,
https://www.fda.gov/AnimalVeterinary/
GuidanceComplianceEnforcement/
GuidanceforIndustry/default.htm,
https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/default.htm, or
https://www.regulations.gov.
VerDate Mar<15>2010
Dated: December 27, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
AGENCY:
Persons with access to the Internet
may obtain the document at either
srobinson on DSK4SPTVN1PROD with NOTICES
Number of
records per
recordkeeper
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry entitled ‘‘Use of Histology in
Biomarker Qualification Studies.’’ This
guidance is intended to assist sponsors
that conduct biomarker qualification
studies for which histology is a
reference standard. This guidance
discusses the processes that should be
considered to ensure the quality and
integrity of histology data in biomarker
studies, and outlines the scientific
standards for histology used in
SUMMARY:
PO 00000
Frm 00039
Fmt 4703
Sfmt 4703
biomarker characterization and
qualification. The recommendations in
this guidance are intended for studies in
biomarker qualification designated to
justify the proposed context of use,
where scientifically rigorous evaluation
of biomarker performance in relation to
histologic changes is essential. The
principles outlined in this guidance are
also applicable to exploratory biomarker
studies.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by March 29,
2012.
Submit either electronic or written
comments concerning the proposed
collection of information by February
28, 2012.
ADDRESSES: Submit written requests for
single copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 2201,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist that office in processing your
requests. See the SUPPLEMENTARY
E:\FR\FM\30DEN1.SGM
30DEN1
Federal Register / Vol. 76, No. 251 / Friday, December 30, 2011 / Notices
section for electronic
access to the draft guidance document.
Submit electronic comments on the
draft guidance to https://www.
regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Elizabeth Hausner, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm. 4145,
Silver Spring, MD 20993–0002, (301)
796–1084.
SUPPLEMENTARY INFORMATION:
INFORMATION
srobinson on DSK4SPTVN1PROD with NOTICES
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Use of Histology in Biomarker
Qualification Studies.’’ The discovery,
characterization, qualification, and
implementation of biomarkers have
been identified by the FDA Critical Path
Initiative as an important means for
improving the efficiency and success
rate of medical product development.
Biomarkers have been broadly applied
to describe the following:
• Structural features from the
molecular to the anatomic level (e.g.,
genetic composition, receptor
expression patterns, radiographic
appearances);
• Biochemical measurements (e.g.,
serum levels of electrolytes, enzyme
activity levels, prostate-specific
antigen);
• Physiologic organ system function
(e.g., creatinine clearance, pulmonary
function tests, cardiac ejection fraction,
electrocardiography).
The studies to be submitted in
support of a biomarker qualification will
depend upon the proposed context of
use and the ultimate goal of the
submission. If a biomarker becomes
qualified, analytically valid
measurements of it can be relied upon
to have a specific and interpretable
meaning (e.g., physiologic, toxicologic,
pharmacologic, or clinical) in drug
development and regulatory
decisionmaking. Industry can then
employ the biomarker for the qualified
context of use during premarketing drug
development, and FDA reviewers can be
confident about the qualified context of
use without the need to reconfirm its
applicability or utility. Accordingly,
biomarker qualification studies are held
to the same Good Laboratory Practice
standards as are other premarketing
studies.
Traditionally, histology has been used
to identify morphologic changes in the
VerDate Mar<15>2010
19:02 Dec 29, 2011
Jkt 226001
context of nonclinical safety assessment,
clinical diagnosis, and evaluation of
response to therapy. There is a strong
correlation between specific histology
findings, clinical outcomes, and some
clinical chemistry parameters. Because
of this history, histology is currently
used in biomarker qualification as a
reference standard to evaluate the
sensitivity and specificity of potential
biomarkers and their ability to indicate
temporal correlation with the evolution
and reversibility of morphologic
changes. Because of the many variations
in the practice of histology, this
guidance is offered to facilitate quality,
consistency, and scientific rigor in
biomarker qualification studies where
histology is used as a reference
standard.
Although great benefit may accrue
from use of a qualified biomarker, a
poorly characterized biomarker can do
considerable harm. A poorly
characterized biomarker may lead to
inappropriate removal of a drug from
development, encourage development of
a drug that is unlikely to be approved,
or lead to an erroneous perception of
safety. Thus, for biomarkers to achieve
the desired goal, the science that
identifies, characterizes, and informs
the biomarker use should be unbiased
and of the highest quality.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the Agency’s current thinking
on the use of histology in biomarker
qualification studies. It does not create
or confer any rights for or on any person
and does not operate to bind FDA or the
public. An alternative approach may be
used if such approach satisfies the
requirements of the applicable statutes
and regulations.
II. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) either electronic or written
comments regarding this document. It is
only necessary to send one set of
comments. It is no longer necessary to
send two copies of mailed comments.
Identify comments with the docket
number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
III. Paperwork Reduction Act of 1995
Under the Paperwork Reduction Act
of 1995 (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
PO 00000
Frm 00040
Fmt 4703
Sfmt 4703
82307
information that 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 for each proposed
collection of information before
submitting the collection to OMB for
approval. To comply with this
requirement, FDA is publishing this
notice of the proposed collection of
information set forth in this document.
With respect to the collection of
information associated with this draft
guidance, FDA invites comments on the
following topics: (1) Whether the
proposed information collected is
necessary for the proper performance of
FDA’s functions, including whether the
information will have practical utility;
(2) the accuracy of FDA’s estimated
burden of the proposed information
collected, including the validity of the
methodology and assumptions used; (3)
ways to enhance the quality, utility, and
clarity of the information collected; and
(4) ways to minimize the burden of
information collected on the
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
This draft guidance refers to
previously approved collections of
information found in FDA regulations.
Sections II, IV, V, and VI of the guidance
request that certain information be
submitted to FDA and certain records be
maintained by the sponsor. We may
request this information under 21 CFR
58.81, 58.120, 58.185, 312.23, and
312.53. The collections of information
for 21 CFR parts 58 and 312 have been
approved under OMB control numbers
0910–0119 and 0910–0014, respectively.
The draft guidance discusses certain
information that should be described in
the standard operating procedures
(SOPs) and recommends that sponsors
document and maintain records of the
SOPs. In addition to the SOPs already
covered by previously approved
collections of information, the draft
guidance recommends that two new
procedures be included in the SOPs.
The new procedures that require OMB
approval for the collection of
information are as follows: (1)
Procedures for describing and
documenting the type and extent of
background lesions and (2) a detailed
description of the pathology peer review
process, including how disagreements
among reviewers will be adjudicated.
E:\FR\FM\30DEN1.SGM
30DEN1
82308
Federal Register / Vol. 76, No. 251 / Friday, December 30, 2011 / Notices
Based on FDA’s data on the number of
sponsors that would be covered by the
draft guidance, we estimate that
approximately 180 SOPs related to
histologic evaluation will include the
new procedures, and that sponsors will
need approximately 30 minutes to
document, maintain, and update their
SOPs with the new procedures.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED RECORDKEEPING BURDEN 1
Number of recordkeepers
Number of records
per recordkeeper
Total annual
records
Average burden
per recordkeeping
(in hours)
Total hours
30
6
180
0.5
90
..............................
..............................
..............................
..............................
90
SOP New Procedures ............................
Total ................................................
1 There
are no capital costs or operating and maintenance costs associated with this information collection.
IV. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
Dated: December 22, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–33553 Filed 12–29–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–D–0659]
Guidance for Industry: Current Good
Tissue Practice and Additional
Requirements for Manufacturers of
Human Cells, Tissues, and Cellular and
Tissue-Based Products; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a document entitled
‘‘Guidance for Industry: Current Good
Tissue Practice (CGTP) and Additional
Requirements for Manufacturers of
Human Cells, Tissues, and Cellular and
Tissue-Based Products (HCT/Ps)’’ dated
December 2011. The guidance
document provides recommendations to
establishments for complying with
CGTP and additional requirements for
manufacturers of HCT/Ps. The guidance
is intended for any HCT/P
establishment that performs a
manufacturing step and is responsible
for complying with CGTP requirements.
The guidance also addresses whether
the establishment registration and HCT/
P listing requirements apply in certain
instances. The guidance announced in
srobinson on DSK4SPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
19:02 Dec 29, 2011
Jkt 226001
this notice finalizes the draft guidance
of the same title dated January 2009.
DATES: Submit either electronic or
written comments on Agency guidances
at any time.
ADDRESSES: Submit written requests for
single copies of the guidance to the
Office of Communication, Outreach and
Development (HFM–40), Center for
Biologics Evaluation and Research
(CBER), Food and Drug Administration,
1401 Rockville Pike, suite 200N,
Rockville, MD 20852–1448. Send one
self-addressed adhesive label to assist
that office in processing your requests.
The guidance may also be obtained by
mail by calling CBER at 1–(800) 835–
4709 or (301) 827–1800. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the guidance
document.
Submit electronic comments on the
guidance to https://www.regulations.gov.
Submit written comments to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville,
MD 20852.
FOR FURTHER INFORMATION CONTACT: Lori
Jo Churchyard, Center for Biologics
Evaluation and Research (HFM–17),
Food and Drug Administration, 1401
Rockville Pike, suite 200N, Rockville,
MD 20852–1448, (301) 827–6210.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a document entitled ‘‘Guidance for
Industry: Current Good Tissue Practice
(CGTP) and Additional Requirements
for Manufacturers of Human Cells,
Tissues, and Cellular and Tissue-Based
Products (HCT/Ps)’’ dated December
2011. The guidance provides
recommendations for complying with
the CGTP requirements under part 1271
(21 CFR part 1271), subpart D, and
additional requirements for
manufacturers of HCT/Ps under part
1271, subpart E. The guidance is
intended for any HCT/P establishment
PO 00000
Frm 00041
Fmt 4703
Sfmt 4703
that performs a manufacturing step and
is responsible for complying with CGTP
requirements. However, at this time,
part 1271, subpart D (with the
exceptions of §§ 1271.150(c) and
1271.155) and subpart E do not apply to
reproductive HCT/P establishments
regulated solely under section 361 of the
Public Health Service Act (42 U.S.C.
264) (the PHS Act). In consideration of
the input FDA received from
stakeholders, this guidance provides
recommendations for establishments
that manufacture HCT/Ps that meet the
criteria listed in § 1271.10 and are
regulated solely under section 361 of the
PHS Act and the regulations in part
1271. CGTP requirements also apply to
HCT/Ps regulated as drugs, devices,
and/or biological products under
section 351 of the PHS Act (42 U.S.C.
262) and/or the Federal Food, Drug, and
Cosmetic Act (see § 1271.1(b)(2)). The
guidance also addresses whether the
establishment registration and HCT/P
listing requirements under part 1271,
subparts A and B, apply in certain
instances.
In the Federal Register of January 16,
2009 (74 FR 3055), FDA announced the
availability of the draft guidance of the
same title dated January 2009. FDA
received numerous comments on the
draft guidance, and those comments
were considered as the guidance was
finalized. In addition, editorial changes
were made to improve clarity. The
guidance announced in this notice
finalizes the draft guidance dated
January 2009.
The guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents FDA’s current
thinking on this topic. It does not create
or confer any rights for or on any person
and does not operate to bind FDA or the
public. An alternative approach may be
used if such approach satisfies the
requirements of the applicable statutes
and regulations.
E:\FR\FM\30DEN1.SGM
30DEN1
Agencies
[Federal Register Volume 76, Number 251 (Friday, December 30, 2011)]
[Notices]
[Pages 82306-82308]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-33553]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-D-0872]
Draft Guidance for Industry on Use of Histology in Biomarker
Qualification Studies; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry entitled ``Use of
Histology in Biomarker Qualification Studies.'' This guidance is
intended to assist sponsors that conduct biomarker qualification
studies for which histology is a reference standard. This guidance
discusses the processes that should be considered to ensure the quality
and integrity of histology data in biomarker studies, and outlines the
scientific standards for histology used in biomarker characterization
and qualification. The recommendations in this guidance are intended
for studies in biomarker qualification designated to justify the
proposed context of use, where scientifically rigorous evaluation of
biomarker performance in relation to histologic changes is essential.
The principles outlined in this guidance are also applicable to
exploratory biomarker studies.
DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by March 29, 2012.
Submit either electronic or written comments concerning the
proposed collection of information by February 28, 2012.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. See the SUPPLEMENTARY
[[Page 82307]]
INFORMATION section for electronic access to the draft guidance
document.
Submit electronic comments on the draft guidance to https://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Elizabeth Hausner, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm. 4145, Silver Spring, MD 20993-0002, (301)
796-1084.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Use of Histology in Biomarker Qualification Studies.'' The
discovery, characterization, qualification, and implementation of
biomarkers have been identified by the FDA Critical Path Initiative as
an important means for improving the efficiency and success rate of
medical product development. Biomarkers have been broadly applied to
describe the following:
Structural features from the molecular to the anatomic
level (e.g., genetic composition, receptor expression patterns,
radiographic appearances);
Biochemical measurements (e.g., serum levels of
electrolytes, enzyme activity levels, prostate-specific antigen);
Physiologic organ system function (e.g., creatinine
clearance, pulmonary function tests, cardiac ejection fraction,
electrocardiography).
The studies to be submitted in support of a biomarker qualification
will depend upon the proposed context of use and the ultimate goal of
the submission. If a biomarker becomes qualified, analytically valid
measurements of it can be relied upon to have a specific and
interpretable meaning (e.g., physiologic, toxicologic, pharmacologic,
or clinical) in drug development and regulatory decisionmaking.
Industry can then employ the biomarker for the qualified context of use
during premarketing drug development, and FDA reviewers can be
confident about the qualified context of use without the need to
reconfirm its applicability or utility. Accordingly, biomarker
qualification studies are held to the same Good Laboratory Practice
standards as are other premarketing studies.
Traditionally, histology has been used to identify morphologic
changes in the context of nonclinical safety assessment, clinical
diagnosis, and evaluation of response to therapy. There is a strong
correlation between specific histology findings, clinical outcomes, and
some clinical chemistry parameters. Because of this history, histology
is currently used in biomarker qualification as a reference standard to
evaluate the sensitivity and specificity of potential biomarkers and
their ability to indicate temporal correlation with the evolution and
reversibility of morphologic changes. Because of the many variations in
the practice of histology, this guidance is offered to facilitate
quality, consistency, and scientific rigor in biomarker qualification
studies where histology is used as a reference standard.
Although great benefit may accrue from use of a qualified
biomarker, a poorly characterized biomarker can do considerable harm. A
poorly characterized biomarker may lead to inappropriate removal of a
drug from development, encourage development of a drug that is unlikely
to be approved, or lead to an erroneous perception of safety. Thus, for
biomarkers to achieve the desired goal, the science that identifies,
characterizes, and informs the biomarker use should be unbiased and of
the highest quality.
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the Agency's current thinking on the use of
histology in biomarker qualification studies. It does not create or
confer any rights for or on any person and does not operate to bind FDA
or the public. An alternative approach may be used if such approach
satisfies the requirements of the applicable statutes and regulations.
II. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed comments. Identify
comments with the docket number found in brackets in the heading of
this document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.
III. Paperwork Reduction Act of 1995
Under the Paperwork Reduction Act of 1995 (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 that
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 for each proposed collection of
information before submitting the collection to OMB for approval. To
comply with this requirement, FDA is publishing this notice of the
proposed collection of information set forth in this document.
With respect to the collection of information associated with this
draft guidance, FDA invites comments on the following topics: (1)
Whether the proposed information collected is necessary for the proper
performance of FDA's functions, including whether the information will
have practical utility; (2) the accuracy of FDA's estimated burden of
the proposed information collected, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information collected; and (4) ways to
minimize the burden of information collected on the respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
This draft guidance refers to previously approved collections of
information found in FDA regulations. Sections II, IV, V, and VI of the
guidance request that certain information be submitted to FDA and
certain records be maintained by the sponsor. We may request this
information under 21 CFR 58.81, 58.120, 58.185, 312.23, and 312.53. The
collections of information for 21 CFR parts 58 and 312 have been
approved under OMB control numbers 0910-0119 and 0910-0014,
respectively.
The draft guidance discusses certain information that should be
described in the standard operating procedures (SOPs) and recommends
that sponsors document and maintain records of the SOPs. In addition to
the SOPs already covered by previously approved collections of
information, the draft guidance recommends that two new procedures be
included in the SOPs. The new procedures that require OMB approval for
the collection of information are as follows: (1) Procedures for
describing and documenting the type and extent of background lesions
and (2) a detailed description of the pathology peer review process,
including how disagreements among reviewers will be adjudicated.
[[Page 82308]]
Based on FDA's data on the number of sponsors that would be covered by
the draft guidance, we estimate that approximately 180 SOPs related to
histologic evaluation will include the new procedures, and that
sponsors will need approximately 30 minutes to document, maintain, and
update their SOPs with the new procedures.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Average burden per
Number of Number of records Total annual recordkeeping (in Total hours
recordkeepers per recordkeeper records hours)
--------------------------------------------------------------------------------------------------------------------------------------------------------
SOP New Procedures.................................. 30 6 180 0.5 90
---------------------------------------------------------------------------------------------------
Total........................................... .................. .................. .................. .................. 90
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this information collection.
IV. Electronic Access
Persons with access to the Internet may obtain the document at
either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov.
Dated: December 22, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-33553 Filed 12-29-11; 8:45 am]
BILLING CODE 4160-01-P