Agency Information Collection Activities: Proposed Collection; Comment Request; Guidance for Industry on Pharmacogenomic Data Submissions, 7198-7199 [2014-02511]
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7198
Federal Register / Vol. 79, No. 25 / Thursday, February 6, 2014 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2007–N–0220]
Agency Information Collection
Activities: Proposed Collection;
Comment Request; Guidance for
Industry on Pharmacogenomic Data
Submissions
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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 resulting
from the submission to the Agency of
pharmacogenomic data during the drug
development process.
DATES: Submit either electronic or
written comments on the collection of
information by April 7, 2014.
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, 1350 Piccard
Dr., PI50–400B, Rockville, MD 20850,
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.
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
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18:18 Feb 05, 2014
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‘‘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.
Guidance for Industry on
Pharmacogenomic Data Submissions—
(OMB Control Number 0910–0557)—
Extension
The guidance provides
recommendations to sponsors
submitting or holding investigational
new drug applications (INDs), new drug
applications (NDAs), or biologics
license applications (BLAs) on what
pharmacogenomic data should be
submitted to the Agency during the drug
development process. Sponsors holding,
and applicants submitting, INDs, NDAs,
or BLAs are subject to FDA
requirements for submitting to the
Agency data relevant to drug safety and
efficacy (21 CFR 312.22, 312.23, 312.31,
312.33, 314.50, 314.81, 601.2, and
601.12).
PO 00000
Frm 00035
Fmt 4703
Sfmt 4703
The guidance interprets FDA
regulations for IND, NDA, or BLA
submissions, clarifying when the
regulations require pharmacogenomics
data to be submitted and when the
submission of such data is voluntary.
The pharmacogenomic data submissions
described in the guidance that are
required to be submitted to an IND,
NDA, BLA, or annual report are covered
by the information collection
requirements under parts 312, 314, and
601 and are approved by OMB under
control numbers 0910–0014 (part 312,
INDs); 0910–0001 (part 314, NDAs and
annual reports); and 0910–0338 (part
601, BLAs).
The guidance distinguishes between
pharmacogenomic tests that may be
considered valid biomarkers appropriate
for regulatory decisionmaking, and
other, less well-developed exploratory
tests. The submission of exploratory
pharmacogenomic data is not required
under the regulations, although the
Agency encourages the voluntary
submission of such data.
The guidance describes the voluntary
genomic data submission (VGDS) that
can be used for such a voluntary
submission. The guidance does not
recommend a specific format for the
VGDS, except that such a voluntary
submission be designated as a VGDS.
The data submitted in a VGDS and the
level of detail should be sufficient for
FDA to be able to interpret the
information and independently analyze
the data, verify results, and explore
possible genotype-phenotype
correlations across studies. FDA does
not want the VGDS to be overly
burdensome and time-consuming for the
sponsor.
FDA has estimated the burden of
preparing a voluntary submission
described in the guidance that should be
designated as a VGDS. Based on FDA’s
experience with these submissions over
the past few years, and on FDA’s
familiarity with sponsors’ interest in
submitting pharmacogenomic data
during the drug development process,
FDA estimates that approximately 4
sponsors will submit approximately 1
VGDS each, and that, on average, each
VGDS will take approximately 50 hours
to prepare and submit to FDA.
FDA estimates the burden of this
information collection as follows:
E:\FR\FM\06FEN1.SGM
06FEN1
Federal Register / Vol. 79, No. 25 / Thursday, February 6, 2014 / Notices
7199
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN1
Activity
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
Voluntary Genomic Data Submissions ................................
4
1
4
50
200
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: January 31, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–02511 Filed 2–5–14; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No.FDA–2004–N–0252]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Color Additive
Certification Requests and
Recordkeeping
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or we) 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 provisions of FDA’s
regulations governing batch certification
of color additives manufactured for use
in foods, drugs, cosmetics, or medical
devices in the United States.
DATES: Submit either electronic or
written comments on the collection of
information by April 7, 2014.
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.
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
18:18 Feb 05, 2014
Jkt 232001
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 1350 Piccard
Dr., PI50–400B, Rockville, MD 20850,
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.
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.
FOR FURTHER INFORMATION CONTACT:
Color Additive Certification Requests
and Recordkeeping—21 CFR Part 80
(OMB Control Number 0910–0216)—
Extension
We have regulatory oversight for color
additives used in foods, drugs,
cosmetics, and medical devices. Section
721(a) of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) (21 U.S.C.
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Fmt 4703
Sfmt 4703
379e(a)) provides that a color additive
shall be deemed to be unsafe unless it
meets the requirements of a listing
regulation, including any requirement
for batch certification, and is used in
accordance with the regulation. We list
color additives that have been shown to
be safe for their intended uses in Title
21 of the Code of Federal Regulations
(CFR). We require batch certification for
all color additives listed in 21 CFR part
74 and for all color additives
provisionally listed in 21 CFR part 82.
Color additives listed in 21 CFR part 73
are exempted from certification.
The requirements for color additive
certification are described in 21 CFR
part 80. In the certification procedure, a
representative sample of a new batch of
color additive, accompanied by a
‘‘request for certification’’ that provides
information about the batch, must be
submitted to FDA’s Office of Cosmetics
and Colors. FDA personnel perform
chemical and other analyses of the
representative sample and, providing
the sample satisfies all certification
requirements, issue a certification lot
number for the batch. We charge a fee
for certification based on the batch
weight and require manufacturers to
keep records of the batch pending and
after certification.
Under § 80.21, a request for
certification must include: Name of
color additive, manufacturer’s batch
number and weight in pounds, name
and address of manufacturer, storage
conditions, statement of use(s),
certification fee, and signature of person
requesting certification. Under § 80.22, a
request for certification must include a
sample of the batch of color additive
that is the subject of the request. The
sample must be labeled to show: Name
of color additive, manufacturer’s batch
number and quantity, and name and
address of person requesting
certification. Under § 80.39, the person
to whom a certificate is issued must
keep complete records showing the
disposal of all the color additive
covered by the certificate. Such records
are to be made available upon request to
any accredited representative of FDA
until at least 2 years after disposal of all
the color additive.
The purpose for collecting this
information is to help us assure that
E:\FR\FM\06FEN1.SGM
06FEN1
]]>Agencies
[Federal Register Volume 79, Number 25 (Thursday, February 6, 2014)]
[Notices]
[Pages 7198-7199]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-02511]
[[Page 7198]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2007-N-0220]
Agency Information Collection Activities: Proposed Collection;
Comment Request; Guidance for Industry on Pharmacogenomic Data
Submissions
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
resulting from the submission to the Agency of pharmacogenomic data
during the drug development process.
DATES: Submit either electronic or written comments on the collection
of information by April 7, 2014.
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, 1350 Piccard Dr., PI50-400B, Rockville,
MD 20850, 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.
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.
Guidance for Industry on Pharmacogenomic Data Submissions--(OMB Control
Number 0910-0557)--Extension
The guidance provides recommendations to sponsors submitting or
holding investigational new drug applications (INDs), new drug
applications (NDAs), or biologics license applications (BLAs) on what
pharmacogenomic data should be submitted to the Agency during the drug
development process. Sponsors holding, and applicants submitting, INDs,
NDAs, or BLAs are subject to FDA requirements for submitting to the
Agency data relevant to drug safety and efficacy (21 CFR 312.22,
312.23, 312.31, 312.33, 314.50, 314.81, 601.2, and 601.12).
The guidance interprets FDA regulations for IND, NDA, or BLA
submissions, clarifying when the regulations require pharmacogenomics
data to be submitted and when the submission of such data is voluntary.
The pharmacogenomic data submissions described in the guidance that are
required to be submitted to an IND, NDA, BLA, or annual report are
covered by the information collection requirements under parts 312,
314, and 601 and are approved by OMB under control numbers 0910-0014
(part 312, INDs); 0910-0001 (part 314, NDAs and annual reports); and
0910-0338 (part 601, BLAs).
The guidance distinguishes between pharmacogenomic tests that may
be considered valid biomarkers appropriate for regulatory
decisionmaking, and other, less well-developed exploratory tests. The
submission of exploratory pharmacogenomic data is not required under
the regulations, although the Agency encourages the voluntary
submission of such data.
The guidance describes the voluntary genomic data submission (VGDS)
that can be used for such a voluntary submission. The guidance does not
recommend a specific format for the VGDS, except that such a voluntary
submission be designated as a VGDS. The data submitted in a VGDS and
the level of detail should be sufficient for FDA to be able to
interpret the information and independently analyze the data, verify
results, and explore possible genotype-phenotype correlations across
studies. FDA does not want the VGDS to be overly burdensome and time-
consuming for the sponsor.
FDA has estimated the burden of preparing a voluntary submission
described in the guidance that should be designated as a VGDS. Based on
FDA's experience with these submissions over the past few years, and on
FDA's familiarity with sponsors' interest in submitting pharmacogenomic
data during the drug development process, FDA estimates that
approximately 4 sponsors will submit approximately 1 VGDS each, and
that, on average, each VGDS will take approximately 50 hours to prepare
and submit to FDA.
FDA estimates the burden of this information collection as follows:
[[Page 7199]]
Table 1--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Voluntary Genomic Data Submissions................................. 4 1 4 50 200
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: January 31, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-02511 Filed 2-5-14; 8:45 am]
BILLING CODE 4160-01-P
