Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Pharmacogenomic Data Submission, 27841-27842 [2017-12604]
Download as PDF
<![CDATA[
Federal Register / Vol. 82, No. 116 / Monday, June 19, 2017 / Notices
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Domini Bean, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A63, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–5733, PRAStaff@
fda.hhs.gov.
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
SUPPLEMENTARY INFORMATION:
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.
Data To Support Drug Product
Communications as Used by the Food
and Drug Administration; OMB Control
Number 0910–0695—Extension
Testing of messages in advance of a
communication campaign provides an
important role in improving FDA
communications. The methods to be
employed include individual indepth
interviews, general public focus group
interviews, intercept interviews, selfadministered surveys, gatekeeper
surveys, and professional clinician
focus group interviews. The qualitative
27841
methods to be used serve the narrowly
defined need for direct and informal
opinion on a specific topic and have
two major purposes: To obtain
information that is useful in formulating
policies and regulatory decisions and
for developing variables and measures
for formulating the basic objectives of
risk communication campaigns, and to
assess the potential effectiveness of
messages and materials in reaching and
successfully communicating with their
intended audiences.
FDA will use these methods to test
and help refine messages and other
communications but will generally
conduct further research before making
important decisions. FDA will use this
mechanism to test messages about
regulated drug products on a variety of
subjects related to consumer, patient, or
health care professional perceptions and
about use of drug products and related
materials, including but not limited to,
direct-to-consumer prescription drug
promotion, physician labeling of
prescription drugs, medication guides,
over-the-counter drug labeling,
emerging risk communications, patient
labeling, online sale of medical
products, and consumer and
professional education. Annually, FDA
projects about 45 communication
studies using the variety of test methods
listed in this document.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Interviews/Surveys ....................................................
1 There
Number of
responses per
respondent
19,822
1
19,822
0.24 (14 minutes) .....
Total hours
4,757
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: June 13, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2017–12601 Filed 6–16–17; 8:45 am]
[Docket No. FDA–2010–N–0536]
BILLING CODE 4164–01–P
asabaliauskas on DSKBBXCHB2PROD with NOTICES
Average burden
per response
(in hours)
Total annual
responses
Food and Drug Administration
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Guidance for
Industry on Pharmacogenomic Data
Submission
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
SUMMARY:
VerDate Sep<11>2014
17:09 Jun 16, 2017
Jkt 241001
PO 00000
Frm 00060
Fmt 4703
Sfmt 4703
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
Fax written comments on the
collection of information by July 19,
2017.
DATES:
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 0910–0557. Also
include the FDA docket number found
in brackets in the heading of this
document.
ADDRESSES:
E:\FR\FM\19JNN1.SGM
19JNN1
27842
Federal Register / Vol. 82, No. 116 / Monday, June 19, 2017 / Notices
FOR FURTHER INFORMATION CONTACT:
Jonnalynn Capezutto, Office of
Operations, Food and Drug
Administration, Three White Flint
North, 10A63, 11601 Landsdown St.,
North Bethesda, MD 20852, 301–796–
3794, PRAStaff@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.
Guidance for Industry on
Pharmacogenomic Data Submissions;
OMB Control Number 0910–0557—
Extension
The collection of information
supports Agency guidance entitled,
‘‘Guidance for Industry on
Pharmacogenomic Data Submissions.’’
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).
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.
In the Federal Register of March 17,
2017 (82 FR 14221), we published a 60day notice requesting public comment
on the proposed extension of this
collection of information. One comment
was received, however it was not
responsive to the four information
collection topics solicited in the notice
and therefore is not addressed here.
FDA has estimated the burden of
preparing a voluntary submission
described in the guidance that should be
designated as a VGDS based on our
experience with these submissions over
the past few years, and on our
familiarity with sponsors’ interest in
submitting pharmacogenomic data
during the drug development process. In
2013, we received three VGDS. Since
2013, there have been no submission of
VGDS; however, for purposes of this
information collection approval, we are
estimating that we may receive one
submission annually. We estimate each
submission requires approximately 50
hours to prepare and submit to FDA.
We therefore estimate the burden of
this collection of information as follows:
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 21 CFR parts 312,
314, and 601 (approved under OMB
control numbers 0910–0014 (part 312,
INDs); 0910–0001 (part 314, NDAs and
annual reports); and 0910–0338 (part
601, BLAs)), respectively.
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
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Information collection activity
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Hours per
response
Total hours
Voluntary Genomic Data Submissions ................................
1
1
1
50
50
1 There
are no capital costs or operating and maintenance costs associated with this collection.
Dated: June 13, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2017–12604 Filed 6–16–17; 8:45 am]
[Docket No. FDA–2017–N–1315]
asabaliauskas on DSKBBXCHB2PROD with NOTICES
BILLING CODE 4164–01–P
Food and Drug Administration
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Experimental
Study of Risk Information Amount and
Location in Direct-to-Consumer Print
Ads
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
SUMMARY:
VerDate Sep<11>2014
17:09 Jun 16, 2017
Jkt 241001
PO 00000
Frm 00061
Fmt 4703
Sfmt 4703
Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
research entitled ‘‘Experimental Study
of Risk Information Amount and
Location in Direct-to-Consumer Print
Ads.’’ This study will examine how
repetition and overwarning apply to the
presentation of risks in the context of
direct-to-consumer print advertising.
DATES: Submit either electronic or
written comments on the collection of
information by August 18, 2017.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
E:\FR\FM\19JNN1.SGM
19JNN1
]]>Agencies
[Federal Register Volume 82, Number 116 (Monday, June 19, 2017)]
[Notices]
[Pages 27841-27842]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-12604]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0536]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Guidance for Industry
on Pharmacogenomic Data Submission
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 July
19, 2017.
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 0910-0557.
Also include the FDA docket number found in brackets in the heading of
this document.
[[Page 27842]]
FOR FURTHER INFORMATION CONTACT: Jonnalynn Capezutto, Office of
Operations, Food and Drug Administration, Three White Flint North,
10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794,
PRAStaff@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.
Guidance for Industry on Pharmacogenomic Data Submissions; OMB Control
Number 0910-0557--Extension
The collection of information supports Agency guidance entitled,
``Guidance for Industry on Pharmacogenomic Data Submissions.'' 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 21 CFR parts
312, 314, and 601 (approved under OMB control numbers 0910-0014 (part
312, INDs); 0910-0001 (part 314, NDAs and annual reports); and 0910-
0338 (part 601, BLAs)), respectively.
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.
In the Federal Register of March 17, 2017 (82 FR 14221), we
published a 60-day notice requesting public comment on the proposed
extension of this collection of information. One comment was received,
however it was not responsive to the four information collection topics
solicited in the notice and therefore is not addressed here.
FDA has estimated the burden of preparing a voluntary submission
described in the guidance that should be designated as a VGDS based on
our experience with these submissions over the past few years, and on
our familiarity with sponsors' interest in submitting pharmacogenomic
data during the drug development process. In 2013, we received three
VGDS. Since 2013, there have been no submission of VGDS; however, for
purposes of this information collection approval, we are estimating
that we may receive one submission annually. We estimate each
submission requires approximately 50 hours to prepare and submit to
FDA.
We therefore estimate the burden of this collection of information
as follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Information collection activity Number of responses per Total annual Hours per Total hours
respondents respondent responses response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Voluntary Genomic Data Submissions................................. 1 1 1 50 50
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection.
Dated: June 13, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-12604 Filed 6-16-17; 8:45 am]
BILLING CODE 4164-01-P
