Agency Information Collection Activities; Proposed Collection; Comment Request; Extralabel Drug Use in Animals, 28858-28860 [2017-13296]
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28858
Federal Register / Vol. 82, No. 121 / Monday, June 26, 2017 / Notices
to ensure that defective devices are
removed from the market. This will
assure that FDA has current and
complete information regarding these
corrections and removals to determine
whether recall action is adequate.
Failure to collect this information
would prevent FDA from receiving
timely information about devices that
may have a serious effect on the health
of users of the devices.
Reports of corrections and removals
may be submitted to FDA via mail or
using FDA’s Electronic Submission
Gateway (ESG). We estimate that
approximately 99 percent of submitters
will use the ESG. Our estimate of the
reporting and recordkeeping burden is
based on Agency records and our
experience with this program, as well as
similar programs that utilize FDA’s ESG.
For respondents who submit
corrections and removals using the
electronic process, the operating and
maintenance costs associated with this
information collection are
approximately $30 per year to purchase
a digital verification certificate
(certificate must be valid for 1 to 3
years). This burden may be minimized
if the respondent has already purchased
a verification certificate for other
electronic submissions to FDA.
However, FDA is assuming that all
respondents who submit corrections
and removals using the electronic
process will be establishing a new
WebTrader account and purchasing a
digital verification certificate. We
therefore estimate the total operating
and maintenance costs to be $30,660
annually (1,022 respondents × $30).
In the Federal Register of March 20,
2017 (82 FR 14367), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Activity
(21 CFR part)
Number of
respondents
Electronic process setup 3 .............
Submission of corrections and removals (part 806) .......................
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours 2
Total operating and
maintenance costs
1,022
1
1,022
3.08
3,148
$30,660
1,033
1
1,033
10
10,330
..................................
1 There
are no capital costs associated with this collection of information.
may not sum due to rounding.
estimate that approximately 99 percent of respondents will submit corrections and removals using the electronic process. The actual burden hours for setup of the electronic process listed in the reporting burden table are divided by 3 to avoid double counting in the Office of Information and Regulatory Affairs Consolidated Information System. However, the one-time Average Burden per Response is 9.25 hours, resulting in
a total one-time burden of 9,454 hours for the setup of the electronic process.
2 Totals
3 We
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Activity
(21 CFR part)
Number of
recordkeepers
Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
Total hours
Records of corrections and removals (part 806) .................
93
1
93
10
930
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: June 20, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–13248 Filed 6–23–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0312]
sradovich on DSK3GMQ082PROD with NOTICES
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Extralabel Drug
Use in Animals
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing an opportunity for public
comment on the proposed collection of
SUMMARY:
VerDate Sep<11>2014
17:04 Jun 23, 2017
Jkt 241001
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (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 reporting
requirements associated with extralabel
drug use in animals.
DATES: Submit either electronic or
written comments on the collection of
information by August 25, 2017.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before August 25,
2017. The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of August 25, 2017.
Comments received by mail/hand
PO 00000
Frm 00045
Fmt 4703
Sfmt 4703
delivery/courier (for written/paper
submissions) will be considered timely
if they are postmarked or the delivery
service acceptance receipt is on or
before that date.
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
E:\FR\FM\26JNN1.SGM
26JNN1
Federal Register / Vol. 82, No. 121 / Monday, June 26, 2017 / Notices
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
sradovich on DSK3GMQ082PROD with NOTICES
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, 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–
2008–N–0312 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request;
Extralabel Drug Use in Animals.’’
Received comments, those filed in a
timely manner (see ADDRESSES), will be
placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff 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
VerDate Sep<11>2014
17:04 Jun 23, 2017
Jkt 241001
both copies to the Dockets Management
Staff. 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.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
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 Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Ila
S. Mizrachi, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A63, 11601 Landsdown
St., North Bethesda, MD 20852, 301–
796–7726, 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
PO 00000
Frm 00046
Fmt 4703
Sfmt 4703
28859
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.
Extralabel Drug Use in Animals—21
CFR Part 530 OMB Control Number
0910–0325—Extension
The Animal Medicinal Drug Use
Clarification Act of 1994 allows a
veterinarian to prescribe the extralabel
use of approved new animal drugs.
Also, it permits FDA, if it finds that
there is a reasonable probability that the
extralabel use of an animal drug may
present a risk to the public health, to
establish a safe level for a residue from
the extralabel use of the drug, and to
require the development of an analytical
method for the detection of residues
above that established safe level (21 CFR
530.22(b)). Although to date, we have
not established a safe level for a residue
from the extralabel use of any new
animal drug and, therefore, have not
required the development of analytical
methodology, we believe that there may
be instances when analytical
methodology will be required. We are,
therefore, estimating the reporting
burden based on two methods being
required annually. The requirement to
establish an analytical method may be
fulfilled by any interested person. We
believe that the sponsor of the drug will
be willing to develop the method in
most cases. Alternatively, FDA, the
sponsor, and perhaps a third party may
cooperatively arrange for method
development. The respondents may be
sponsors of new animal drugs, State, or
Federal and/or State Agencies,
academia, or individuals.
FDA estimates the burden of this
collection of information as follows:
E:\FR\FM\26JNN1.SGM
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28860
Federal Register / Vol. 82, No. 121 / Monday, June 26, 2017 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
530.22(b), Submission(s) of Analytical Method ...................
1 There
Dated: June 20, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–13296 Filed 6–23–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–0809]
Issuance of Priority Review Voucher;
Rare Pediatric Disease Product
Food and Drug Administration,
HHS.
ACTION:
2
Notice.
The Food and Drug
Administration (FDA) is announcing the
issuance of a priority review voucher to
the sponsor of a rare pediatric disease
product application. The Federal Food,
Drug, and Cosmetic Act (the FD&C Act),
as amended by the Food and Drug
Administration Safety and Innovation
Act (FDASIA), authorizes FDA to award
priority review vouchers to sponsors of
approved rare pediatric disease product
applications that meet certain criteria.
FDA is required to publish notice of the
award of the priority review voucher.
FDA has determined that Brineura
(cerliponase alfa) manufactured by
Biomarin Pharmaceuticals Inc., meets
the criteria for a priority review
voucher.
SUMMARY:
1
priority review vouchers to sponsors of
approved rare pediatric disease product
applications that meet certain criteria.
FDA has determined that Brineura
(cerliponase alfa) manufactured by
Biomarin Pharmaceuticals Inc., meets
the criteria for a priority review
voucher. Brineura (cerliponase alfa) is
indicated to slow the progression of loss
of ambulation in symptomatic pediatric
patients 3 years of age and older with
late infantile neuronal ceroid
lipofuscinosis type 2 (CLN2), also
known as tripeptidyl peptidase 1 (TPP1)
deficiency.
For further information about the Rare
Pediatric Disease Priority Review
Voucher Program and for a link to the
full text of section 529 of the FD&C Act,
go to https://www.fda.gov/ForIndustry/
DevelopingProductsf
orRareDiseasesConditions/
RarePediatricDisease
PriorityVoucherProgram/default.htm.
For further information about Brineura
(cerliponase alfa) go to the ‘‘Drugs@
FDA’’ Web site at https://
www.accessdata.fda.gov/scripts/cder/
daf/.
Dated: June 20, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–13236 Filed 6–23–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–1066]
FOR FURTHER INFORMATION CONTACT:
sradovich on DSK3GMQ082PROD with NOTICES
Average
burden per
response
Total annual
responses
2
4,160
Total hours
8,320
are no capital costs or operating and maintenance costs associated with this collection of information.
The burden for this information
collection has not changed since the last
OMB approval.
AGENCY:
Number of
responses per
respondent
Number of
respondents
21 CFR section
Althea Cuff, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 22, Rm. 6484, Silver Spring,
MD 20993–0002, 301–796–4061, FAX:
301–796–9858, email: althea.cuff@
fda.hhs.gov.
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Annual Reporting
for Custom Device Exemption
FDA is
announcing the issuance of a priority
review voucher to the sponsor of an
approved rare pediatric disease product
application. Under section 529 of the
FD&C Act (21 U.S.C. 360ff), which was
added by FDASIA, FDA will award
ACTION:
SUPPLEMENTARY INFORMATION:
VerDate Sep<11>2014
17:04 Jun 23, 2017
Jkt 241001
AGENCY:
Food and Drug Administration,
HHS.
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
SUMMARY:
PO 00000
Frm 00047
Fmt 4703
Sfmt 4703
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by July 26,
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 0910–0767. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Amber Sanford, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A63, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–8867, 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.
Annual Reporting for Custom Device
Exemption OMB Control Number 0910–
0767—Extension
The custom device exemption is set
forth at section 520(b)(2)(B) of the
Federal Food, Drug, and Cosmetic Act
(the FD&C Act) (21 U.S.C. 360j(b)(2)(B)).
A custom device is in a narrow category
of device that, by virtue of the rarity of
the patient’s medical condition or
physician’s special need the device is
designed to treat, it would be
impractical for the device to comply
with premarket review regulations and
performance standards.
The Food and Drug Administration
Safety and Innovation Act (FDASIA)
implemented changes to the custom
device exemption contained in section
520(b) of the FD&C Act. The new
provision amended the existing custom
device exemption and introduced new
concepts and procedures for custom
devices, such as:
• Devices created or modified in
order to comply with the order of an
individual physician or dentist;
E:\FR\FM\26JNN1.SGM
26JNN1
Agencies
[Federal Register Volume 82, Number 121 (Monday, June 26, 2017)]
[Notices]
[Pages 28858-28860]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-13296]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0312]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Extralabel Drug Use in Animals
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(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 reporting requirements associated with
extralabel drug use in animals.
DATES: Submit either electronic or written comments on the collection
of information by August 25, 2017.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before August 25, 2017. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of August 25, 2017. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.
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
[[Page 28859]]
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): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, 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-2008-N-0312 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Extralabel Drug Use in Animals.''
Received comments, those filed in a timely manner (see ADDRESSES), will
be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff 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 Dockets Management Staff. 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.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
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 Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A63, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-7726,
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.
Extralabel Drug Use in Animals--21 CFR Part 530 OMB Control Number
0910-0325--Extension
The Animal Medicinal Drug Use Clarification Act of 1994 allows a
veterinarian to prescribe the extralabel use of approved new animal
drugs. Also, it permits FDA, if it finds that there is a reasonable
probability that the extralabel use of an animal drug may present a
risk to the public health, to establish a safe level for a residue from
the extralabel use of the drug, and to require the development of an
analytical method for the detection of residues above that established
safe level (21 CFR 530.22(b)). Although to date, we have not
established a safe level for a residue from the extralabel use of any
new animal drug and, therefore, have not required the development of
analytical methodology, we believe that there may be instances when
analytical methodology will be required. We are, therefore, estimating
the reporting burden based on two methods being required annually. The
requirement to establish an analytical method may be fulfilled by any
interested person. We believe that the sponsor of the drug will be
willing to develop the method in most cases. Alternatively, FDA, the
sponsor, and perhaps a third party may cooperatively arrange for method
development. The respondents may be sponsors of new animal drugs,
State, or Federal and/or State Agencies, academia, or individuals.
FDA estimates the burden of this collection of information as
follows:
[[Page 28860]]
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
21 CFR section Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
530.22(b), Submission(s) of 2 1 2 4,160 8,320
Analytical Method..............
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
The burden for this information collection has not changed since
the last OMB approval.
Dated: June 20, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-13296 Filed 6-23-17; 8:45 am]
BILLING CODE 4164-01-P