Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Pharmacogenomic Data Submissions, 14221-14223 [2017-05293]
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14221
Federal Register / Vol. 82, No. 51 / Friday, March 17, 2017 / Notices
Exhibit 2 shows the estimated
annualized cost burden based on the
respondents’ time to complete one
submission process. The cost burden is
estimated to be $22,153 annually.
EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN
Number of
respondents
Form name
Total burden
hours
Average
hourly wage
rate *
Total cost
burden
Registration Form ............................................................................................
Health Plan Information Form .........................................................................
Data Use Agreement .......................................................................................
Data Files Submission .....................................................................................
85
75
75
85
7
150
4
340
a 50.99
c 40.56
$357
7,649
357
13,790
Total ..........................................................................................................
320
501
NA
22,153
a 50.99
b 89.35
* National Compensation Survey: Occupational wages in the United States May 2015, ‘‘U.S. Department of Labor, Bureau of Labor Statistics.’’
a Based on the mean hourly wage for Medical and Health Services Managers (11–9111).
b Based on the mean hourly wage for Chief Executives (11–1011).
c Based on the mean hourly wages for Computer Programmer (15–1131).
Request for Comments
In accordance with the Paperwork
Reduction Act, comments on AHRQ’s
information collection are requested
with regard to any of the following: (a)
Whether the proposed collection of
information is necessary for the proper
performance of AHRQ health care
research and health care information
dissemination functions, including
whether the information will have
practical utility; (b) the accuracy of
AHRQ’s estimate of burden (including
hours and costs) of the proposed
collection(s) of information; (c) ways to
enhance the quality, utility, and clarity
of the information to be collected; and
(d) ways to minimize the burden of the
collection of information upon the
respondents, including the use of
automated collection techniques or
other forms of information technology.
Comments submitted in response to
this notice will be summarized and
included in the Agency’s subsequent
request for OMB approval of the
proposed information collection. All
comments will become a matter of
public record.
Sharon B. Arnold,
Acting Director.
[FR Doc. 2017–05301 Filed 3–16–17; 8:45 am]
asabaliauskas on DSK3SPTVN1PROD with NOTICES
BILLING CODE 4160–90–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0536]
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, Agency, 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 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 May 16, 2017.
ADDRESSES: You may submit comments
as follows:
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
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PO 00000
Frm 00024
Fmt 4703
Sfmt 4703
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, FDA will post your
comment, as well as any attachments,
except for information submitted,
marked and identified, as confidential,
if submitted as detailed in
‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2010–N–0536 for ‘‘Guidance for
Industry on Pharmacogenomic Data
Submissions.’’ Received comments will
be placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
E:\FR\FM\17MRN1.SGM
17MRN1
asabaliauskas on DSK3SPTVN1PROD with NOTICES
14222
Federal Register / Vol. 82, No. 51 / Friday, March 17, 2017 / Notices
Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Division of Dockets
Management. If you do not wish your
name and contact information to be
made publicly available, you can
provide this information on the cover
sheet and not in the body of your
comments and you must identify this
information as ‘‘confidential.’’ Any
information marked as ‘‘confidential’’
will not be disclosed except in
accordance with 21 CFR 10.20 and other
applicable disclosure law. For more
information about FDA’s posting of
comments to public dockets, see 80 FR
56469, September 18, 2015, or access
the information at: https://www.fda.gov/
regulatoryinformation/dockets/
default.htm.
Docket: For access to the docket to
read background documents or the
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 Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A63, 11601 Landsdown
St., North Bethesda, MD 20852,
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
VerDate Sep<11>2014
20:02 Mar 16, 2017
Jkt 241001
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
PO 00000
Frm 00025
Fmt 4703
Sfmt 4703
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 (approved under OMB 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 decision-making, 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 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:
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Federal Register / Vol. 82, No. 51 / Friday, March 17, 2017 / Notices
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: March 13, 2017.
Leslie Kux,
Associate Commissioner for Policy.
Premarket Notification—21 CFR Part
807, Subpart E
[FR Doc. 2017–05293 Filed 3–16–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0804]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Premarket
Notification
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by April 17,
2017.
SUMMARY:
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 0910–0120. Also
include the FDA docket number found
in brackets in the heading of this
document.
ADDRESSES:
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, Three White
Flint North 10A63, 11601 Landsdown
St., North Bethesda, MD 20852,
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.
asabaliauskas on DSK3SPTVN1PROD with NOTICES
FOR FURTHER INFORMATION CONTACT:
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OMB Control Number 0910–0120—
Reinstatement
Section 510(k) of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act)
(21 U.S.C. 360(k)) and the implementing
regulation under part 807 (21 CFR part
807, subpart E) require a person who
intends to market a medical device to
submit a premarket notification
submission to FDA at least 90 days
before proposing to begin the
introduction, or delivery for
introduction into interstate commerce,
for commercial distribution of a device
intended for human use. Based on the
information provided in the
notification, FDA must determine
whether the new device is substantially
equivalent to a legally marketed device,
as defined in § 807.92(a)(3) (21 CFR
807.92(a)(3)). If the device is determined
to be not substantially equivalent to a
legally marketed device, it must have an
approved premarket approval
application (PMA), product
development protocol, humanitarian
device exemption (HDE), petition for
Evaluation of Automatic Class III
Designation (de novo), or be reclassified
into class I or class II before being
marketed. FDA makes the final decision
of whether a device is substantially
equivalent or not equivalent.
Section 807.81 states when a
premarket notification is required. A
premarket notification is required to be
submitted by a person who is: (1)
Introducing a device to the market for
the first time; (2) introducing a device
into commercial distribution for the first
time by a person who is required to
register; and (3) introducing or
reintroducing a device which is
significantly changed or modified in
design, components, method of
manufacturer, or the intended use that
could affect the safety and effectiveness
of the device.
Form FDA 3514, a summary cover
sheet form, assists respondents in
categorizing administrative 510(k)
information for submission to FDA. This
form also assists respondents in
categorizing information for other FDA
medical device programs such as PMAs,
investigational device exemptions, and
PO 00000
Frm 00026
Fmt 4703
Sfmt 4703
HDEs. Under § 807.87(h), each 510(k)
submitter must include in the 510(k)
either a summary of the information in
the 510(k) as required by § 807.92
(510(k) summary) or a statement
certifying that the submitter will make
available upon request the information
in the 510(k) with certain exceptions as
per § 807.93 (510(k) statement). If the
510(k) submitter includes a 510(k)
statement in the 510(k) submission,
§ 807.93 requires that the official
correspondent of the firm make
available within 30 days of a request all
information included in the submitted
premarket notification on safety and
effectiveness. This information will be
provided to any person within 30 days
of a request if the device described in
the 510(k) submission is determined to
be substantially equivalent. The
information provided will be a
duplicate of the 510(k) submission
including any safety and effectiveness
information, but excluding all patient
identifiers and trade secret and
commercial confidential information.
Section 204 of the Food and Drug
Administration Modernization Act
(FDAMA) (Pub. L. 105–115) amended
section 514 of the FD&C Act (21 U.S.C.
360d). Amended section 514 allows
FDA to recognize consensus standards
developed by international and national
organizations for use in satisfying
portions of device premarket review
submissions including premarket
notifications or other requirements. FDA
has published and updated the list of
recognized standards regularly since
enactment of FDAMA and has allowed
510(k) submitters to certify conformance
to recognized standards to meet the
requirements of § 807.87. Form FDA
3654, the 510(k) Standards Data Form,
standardizes the format for submitting
information on consensus standards that
a 510(k) submitter chooses to use as a
portion of their premarket notification
submission (Form FDA 3654 is not for
declarations of conformance to a
recognized standard). FDA believes that
use of this form will simplify the 510(k)
preparation and review process for
510(k).
Under § 807.90, submitters may
request information on their 510(k)
review status 90 days after the initial
login date of the 510(k). Thereafter, the
E:\FR\FM\17MRN1.SGM
17MRN1
]]>Agencies
[Federal Register Volume 82, Number 51 (Friday, March 17, 2017)]
[Notices]
[Pages 14221-14223]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-05293]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0536]
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, Agency, 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 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 May 16, 2017.
ADDRESSES: You may submit comments as follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2010-N-0536 for ``Guidance for Industry on Pharmacogenomic Data
Submissions.'' Received comments will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at https://www.regulations.gov or at the
[[Page 14222]]
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.fda.gov/regulatoryinformation/dockets/default.htm.
Docket: For access to the docket to read background documents or
the 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 Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A63, 11601
Landsdown St., North Bethesda, MD 20852, 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 (approved under OMB 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 decision-
making, 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
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:
[[Page 14223]]
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: March 13, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-05293 Filed 3-16-17; 8:45 am]
BILLING CODE 4164-01-P
