Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Exceptions or Alternatives to Labeling Requirements for Products Held by the Strategic National Stockpile, 37101-37103 [2017-16648]
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37101
Federal Register / Vol. 82, No. 151 / Tuesday, August 8, 2017 / Notices
TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1—Continued
Number of
respondents
21 CFR section/activity
Number of
disclosures
per
respondent
Total annual
disclosures
Average
burden per
disclosure
Total hours
701.12—Name and place of business ................................
701.13—Net quantity of contents ........................................
1,518
1,518
24
24
36,432
36,432
1
1
36,432
36,432
Total ..............................................................................
........................
........................
........................
........................
141,174
asabaliauskas on DSKBBXCHB2PROD with NOTICES
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
The hour burden is the additional or
incremental time that establishments
need to design and print labeling that
includes the following required
elements: A declaration of ingredients
in decreasing order of predominance, a
statement of the identity of the product,
a specification of the name and place of
business of the establishment, and a
declaration of the net quantity of
contents. These requirements increase
the time establishments need to design
labels because they increase the number
of label elements that establishments
must take into account when designing
labels. These requirements do not
generate any recurring burden per label
because establishments must already
print and affix labels to cosmetic
products as part of normal business
practices.
The estimated annual third-party
disclosure is based on data available to
the Agency, our knowledge of and
experience with cosmetic labeling, and
our communications with industry. We
estimate there are 1,518 cosmetic
product establishments in the United
States. We calculate label design costs
based on stock keeping units (SKUs)
because each SKU has a unique product
label. Based on data available to the
Agency and on communications with
industry, we estimate that cosmetic
establishments will offer 94,800 SKUs
for retail sale in 2017. This corresponds
to an average of 62 SKUs per
establishment.
One of the four provisions that we
discuss in this information collection,
§ 701.3, applies only to cosmetic
products offered for retail sale.
However, the other three provisions,
§§ 701.11, 701.12, and 701.13, apply to
all cosmetic products, including nonretail professional-use-only products.
We estimate that including professionaluse-only cosmetic products increases
the total number of SKUs by 15 percent
to 109,020. This corresponds to an
average of 72 SKUs per establishment.
Finally, based on the Agency’s
experience with other products, we
estimate that cosmetic establishments
may redesign up to one-third of SKUs
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per year. Therefore, we estimate that the
number of disclosures per respondent
will be 21 (31,878 SKUs) for § 701.3 and
24 each (36,432 SKUs) for §§ 701.11,
701.12, and 701.13.
We estimate that each of the required
label elements may add approximately 1
hour to the label design process. We
base this estimate on the hour burdens
the Agency has previously estimated for
food, drug, and medical device labeling
and on the Agency’s knowledge of
cosmetic labeling. Therefore, we
estimate that the total hour burden on
members of the public for this
information collection is 141,174 hours
per year.
Dated: August 2, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–16649 Filed 8–7–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0588]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Exceptions or
Alternatives to Labeling Requirements
for Products Held by the Strategic
National Stockpile
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 September
7, 2017.
ADDRESSES: To ensure that comments on
the information collection are received,
SUMMARY:
PO 00000
Frm 00062
Fmt 4703
Sfmt 4703
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 0910–0614. Also
include the FDA docket number found
in brackets in the heading of this
document.
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.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Exceptions or Alternatives to Labeling
Requirements for Products Held by the
Strategic National Stockpile; OMB
Control Number 0910–0614—Extension
Under the Public Health Service Act
(PHS Act), the Department of Health
and Human Services stockpiles medical
products that are essential to the health
security of the Nation (see the PHS Act,
42 U.S.C. 247d–6b). This collection of
medical products for use during
national health emergencies, known as
the Strategic National Stockpile (SNS),
is to ‘‘provide for the emergency health
security of the United States, including
the emergency health security of
children and other vulnerable
populations, in the event of a
bioterrorist attack or other public health
emergency.’’ It may be appropriate for
certain medical products that are or will
be held in the SNS to be labeled in a
manner that would not comply with
certain FDA labeling regulations given
their anticipated circumstances of use in
an emergency. However, noncompliance
with these labeling requirements could
render such products misbranded under
section 502 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 352).
E:\FR\FM\08AUN1.SGM
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37102
Federal Register / Vol. 82, No. 151 / Tuesday, August 8, 2017 / Notices
Under 21 CFR 201.26, 610.68,
801.128, and 809.11 (§§ 201.26, 610.68,
801.128, and 809.11), the appropriate
FDA Center Director may grant a request
for an exception or alternative to certain
regulatory provisions pertaining to the
labeling of human drugs, biological
products, medical devices, and in vitro
diagnostics that currently are or will be
included in the SNS if certain criteria
are met. The appropriate FDA Center
Director may grant an exception or
alternative to certain FDA labeling
requirements if compliance with these
labeling requirements could adversely
affect the safety, effectiveness, or
availability of products that are or will
be included in the SNS. An exception
or alternative granted under the
regulations may include conditions or
safeguards so that the labeling for such
products includes appropriate
information necessary for the safe and
effective use of the product given the
product’s anticipated circumstances of
use. Any grant of an exception or
alternative will only apply to the
specified lots, batches, or other units of
medical products in the request. The
appropriate FDA Center Director may
also grant an exception or alternative to
the labeling provisions specified in the
regulations on his or her own initiative.
Under §§ 201.26(b)(1)(i) (human drug
products), 610.68(b)(1)(i) (biological
products), 801.128(b)(1)(i) (medical
devices), and 809.11(b)(1)(i) (in vitro
diagnostic products for human use), an
SNS official or any entity that
manufactures (including labeling,
packing, relabeling, or repackaging),
distributes, or stores such products that
are or will be included in the SNS may
submit, with written concurrence from
a SNS official, a written request for an
exception or alternative to certain
labeling requirements to the appropriate
FDA Center Director. Except when
initiated by an FDA Center Director, a
request for an exception or alternative
must be in writing and must:
• Identify the specified lots, batches,
or other units of the affected product;
• Identify the specific labeling
provisions under the regulations that are
the subject of the request;
• Explain why compliance with the
specified labeling provisions could
adversely affect the safety, effectiveness,
or availability of the product subject to
the request;
• Describe any proposed safeguards
or conditions that will be implemented
so that the labeling of the product
includes appropriate information
necessary for the safe and effective use
of the product given the anticipated
circumstances of use of the product;
• Provide copies of the proposed
labeling of the specified lots, batches, or
other units of the affected product that
will be subject to the exception or
alternative; and
• Provide any other information
requested by the FDA Center Director in
support of the request.
If the request is granted, the
manufacturer may need to report to FDA
any resulting changes to the new drug
application, biologics license
application, premarket approval
application, or premarket notification
(510(k)) in effect, if any. The submission
and grant of an exception or an
alternative to the labeling requirements
specified in the regulations may be used
to satisfy certain reporting obligations
relating to changes to product
applications under §§ 314.70, 601.12,
814.39 and 807.81 (21 CFR 314.70
(human drugs), 21 CFR 601.12
(biological products), 21 CFR 814.39
(medical devices subject to premarket
approval), or 21 CFR 807.81 (medical
devices subject to 510(k) clearance
requirements)).
The information collection provisions
in §§ 314.70, 601.12, 807.81, and 814.39
have been approved under OMB control
numbers 0910–0001, 0910–0338, 0910–
0120, and 0910–0231, respectively. On
a case-by-case basis, the appropriate
FDA Center Director may also determine
when an exception or alternative is
granted that certain safeguards and
conditions are appropriate, such as
additional labeling on the SNS
products, so that the labeling of such
products would include information
needed for safe and effective use under
the anticipated circumstances of use.
Respondents to this collection of
information are entities that
manufacture (including labeling,
packing, relabeling, or repackaging),
distribute, or store affected SNS
products. Based on data from fiscal
years 2014 and 2015, FDA estimates an
average of one request annually for an
exception or alternative received by
FDA. FDA estimates an average of 24
hours preparing each request. The
average burden per response for each
submission is based on the estimated
time that it takes to prepare a
supplement to an application, which
may be considered similar to a request
for an exception or alternative. To the
extent that labeling changes not already
required by FDA regulations are made
in connection with an exception or
alternative granted under the
regulations, FDA is estimating one
occurrence annually in the event FDA
would require any additional labeling
changes not already covered by FDA
regulations. FDA estimates 8 hours to
develop and revise the labeling to make
such changes. The average burden per
response for each submission is based
on the estimated time to develop and
revise the labeling to make such
changes.
In the Federal Register of May 23,
2017 (82 FR 23584), we published a 60day notice requesting public comment
on the proposed extension of this
collection of information. No comments
were received.
We therefore estimate the burden of
this collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
asabaliauskas on DSKBBXCHB2PROD with NOTICES
201.26(b)(1)(i),
809.11(b)(1)(i)
201.26(b)(1)(i),
809.11(b)(1)(i)
610.68(b)(1)(i), 801.128(b)(1)(i), and
...................................................................
610.68(b)(1)(i), 801.128(b)(1)(i), and
...................................................................
Total ..............................................................................
1 There
Number of
responses per
respondent
Number of
respondents
21 CFR Section
Average
burden per
response
(in hours)
Total annual
responses
1
1
1
24
24
1
1
1
8
8
........................
........................
........................
........................
32
are no capital costs or operating and maintenance costs associated with this collection of information.
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PO 00000
Total hours
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Sfmt 4703
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37103
Federal Register / Vol. 82, No. 151 / Tuesday, August 8, 2017 / Notices
Dated: August 2, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–16648 Filed 8–7–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request Information
Collection Request Title: Office of
Patient Advocacy/Be The Match®
Patient Services Survey, OMB No.
0906–0004, Revision
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
In compliance with the
requirement for opportunity for public
comment on proposed data collection
projects of the Paperwork Reduction Act
of 1995, HRSA announces plans to
submit an Information Collection
Request (ICR), described below, to the
Office of Management and Budget
(OMB). Prior to submitting the ICR to
OMB, HRSA seeks comments from the
public regarding the burden estimate,
below, or any other aspect of the ICR.
DATES: Comments on this ICR must be
received no later than October 10, 2017.
ADDRESSES: Submit your comments to
paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance
Officer, Room 14N39, 5600 Fishers
Lane, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and draft
instruments, email paperwork@hrsa.gov
or call the HRSA Information Collection
Clearance Officer at (301) 443–1984.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
SUMMARY:
information, please include the
information request collection title for
reference, in compliance with Section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995.
Information Collection Request Title:
Office of Patient Advocacy/Be The
Match® Patient Services Survey, OMB
No. 0906–0004—Revision.
Abstract: The National Marrow Donor
Program®/Be The Match® is a HRSA
contractor dedicated to helping patients
and families get the support and
information they need to learn about
their disease and treatment options,
prepare for a blood stem cell transplant,
and thrive after a transplant procedure.
The information and resources provided
help individuals navigate the bone
marrow or cord blood transplant
process. Participant feedback is
essential to understand the needs for
transplant support services and
educational information across a diverse
population. This information is used to
determine helpfulness of existing
services and resources. Feedback is also
used to identify areas for improvement
and develop future programs.
Need and Proposed Use of the
Information: Barriers to access to bone
marrow or cord blood transplant related
care and educational information are
multi-factorial. Feedback from
participants is essential to better
understand the changing needs for
services and information as well as to
demonstrate the effectiveness of existing
services. The primary use for
information gathered through the survey
is to determine helpfulness of
participants’ initial contact with Be The
Match® Patient Services Coordinators
(PSC) and to identify areas for
improvement in the delivery of services.
In addition, stakeholders use this
evaluation data to make program and
resource allocation decisions.
The survey includes items to measure
the following: (1) Reason for contacting
Be The Match®, (2) if the PSC was able
to answer questions and was easy to
understand, (3) if the contact helped the
participant to feel better prepared to
discuss transplants with their care team,
(4) increase in awareness of available
resources, (5) timeliness of response,
and (6) overall satisfaction.
The proposed changes to the survey
instrument include minor changes to
both selected survey questions and the
instructions. The updated survey
questions include simplified language
and the references to race and ethnicity
are updated to better match preliminary
U.S. Census Bureau question format and
statements from the U.S. Department of
Education. The question format changes
will better allow individuals to selfidentify their ethnicity and race and
permit individuals to select more than
one race and/or ethnicity. These
changes will not increase respondent
burden.
Likely Respondents: Respondents will
include all patients, caregivers and
family members who have contact with
Be The Match Patient Services
Coordinators via phone or email for
transplant navigation services and
support. The decision to survey all
participants was made based on historic
evidence of patients’ unavailability due
to frequent transitions in health status
as well as between home and the
hospital for initial treatment and care
for complications.
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
disclose or provide the information
requested. This includes the time
needed to review instructions; to
develop, acquire, install, and utilize
technology and systems for the purpose
of collecting, validating, and verifying
information, processing and
maintaining information, and disclosing
and providing information; to train
personnel and to be able to respond to
a collection of information; to search
data sources; to complete and review
the collection of information; and to
transmit or otherwise disclose the
information. The total annual burden
hours estimated for this ICR are
summarized in the table below.
TOTAL ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
asabaliauskas on DSKBBXCHB2PROD with NOTICES
Form name
Number of
responses per
respondent
Total
responses
Average
burden per
response
(in hours)
Total
burden hours
Be The Match Patient Services Survey ...............................
420
1
420
0.25
105
Total ..............................................................................
420
........................
420
........................
105
HRSA specifically requests comments
on (1) the necessity and utility of the
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proposed information collection for the
proper performance of the agency’s
PO 00000
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Fmt 4703
Sfmt 4703
functions; (2) the accuracy of the
estimated burden; (3) ways to enhance
E:\FR\FM\08AUN1.SGM
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Agencies
[Federal Register Volume 82, Number 151 (Tuesday, August 8, 2017)]
[Notices]
[Pages 37101-37103]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-16648]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0588]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Exceptions or
Alternatives to Labeling Requirements for Products Held by the
Strategic National Stockpile
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
September 7, 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 0910-0614.
Also include the FDA docket number found in brackets in the heading of
this document.
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.
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.
Exceptions or Alternatives to Labeling Requirements for Products Held
by the Strategic National Stockpile; OMB Control Number 0910-0614--
Extension
Under the Public Health Service Act (PHS Act), the Department of
Health and Human Services stockpiles medical products that are
essential to the health security of the Nation (see the PHS Act, 42
U.S.C. 247d-6b). This collection of medical products for use during
national health emergencies, known as the Strategic National Stockpile
(SNS), is to ``provide for the emergency health security of the United
States, including the emergency health security of children and other
vulnerable populations, in the event of a bioterrorist attack or other
public health emergency.'' It may be appropriate for certain medical
products that are or will be held in the SNS to be labeled in a manner
that would not comply with certain FDA labeling regulations given their
anticipated circumstances of use in an emergency. However,
noncompliance with these labeling requirements could render such
products misbranded under section 502 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 352).
[[Page 37102]]
Under 21 CFR 201.26, 610.68, 801.128, and 809.11 (Sec. Sec.
201.26, 610.68, 801.128, and 809.11), the appropriate FDA Center
Director may grant a request for an exception or alternative to certain
regulatory provisions pertaining to the labeling of human drugs,
biological products, medical devices, and in vitro diagnostics that
currently are or will be included in the SNS if certain criteria are
met. The appropriate FDA Center Director may grant an exception or
alternative to certain FDA labeling requirements if compliance with
these labeling requirements could adversely affect the safety,
effectiveness, or availability of products that are or will be included
in the SNS. An exception or alternative granted under the regulations
may include conditions or safeguards so that the labeling for such
products includes appropriate information necessary for the safe and
effective use of the product given the product's anticipated
circumstances of use. Any grant of an exception or alternative will
only apply to the specified lots, batches, or other units of medical
products in the request. The appropriate FDA Center Director may also
grant an exception or alternative to the labeling provisions specified
in the regulations on his or her own initiative.
Under Sec. Sec. 201.26(b)(1)(i) (human drug products),
610.68(b)(1)(i) (biological products), 801.128(b)(1)(i) (medical
devices), and 809.11(b)(1)(i) (in vitro diagnostic products for human
use), an SNS official or any entity that manufactures (including
labeling, packing, relabeling, or repackaging), distributes, or stores
such products that are or will be included in the SNS may submit, with
written concurrence from a SNS official, a written request for an
exception or alternative to certain labeling requirements to the
appropriate FDA Center Director. Except when initiated by an FDA Center
Director, a request for an exception or alternative must be in writing
and must:
Identify the specified lots, batches, or other units of
the affected product;
Identify the specific labeling provisions under the
regulations that are the subject of the request;
Explain why compliance with the specified labeling
provisions could adversely affect the safety, effectiveness, or
availability of the product subject to the request;
Describe any proposed safeguards or conditions that will
be implemented so that the labeling of the product includes appropriate
information necessary for the safe and effective use of the product
given the anticipated circumstances of use of the product;
Provide copies of the proposed labeling of the specified
lots, batches, or other units of the affected product that will be
subject to the exception or alternative; and
Provide any other information requested by the FDA Center
Director in support of the request.
If the request is granted, the manufacturer may need to report to
FDA any resulting changes to the new drug application, biologics
license application, premarket approval application, or premarket
notification (510(k)) in effect, if any. The submission and grant of an
exception or an alternative to the labeling requirements specified in
the regulations may be used to satisfy certain reporting obligations
relating to changes to product applications under Sec. Sec. 314.70,
601.12, 814.39 and 807.81 (21 CFR 314.70 (human drugs), 21 CFR 601.12
(biological products), 21 CFR 814.39 (medical devices subject to
premarket approval), or 21 CFR 807.81 (medical devices subject to
510(k) clearance requirements)).
The information collection provisions in Sec. Sec. 314.70, 601.12,
807.81, and 814.39 have been approved under OMB control numbers 0910-
0001, 0910-0338, 0910-0120, and 0910-0231, respectively. On a case-by-
case basis, the appropriate FDA Center Director may also determine when
an exception or alternative is granted that certain safeguards and
conditions are appropriate, such as additional labeling on the SNS
products, so that the labeling of such products would include
information needed for safe and effective use under the anticipated
circumstances of use.
Respondents to this collection of information are entities that
manufacture (including labeling, packing, relabeling, or repackaging),
distribute, or store affected SNS products. Based on data from fiscal
years 2014 and 2015, FDA estimates an average of one request annually
for an exception or alternative received by FDA. FDA estimates an
average of 24 hours preparing each request. The average burden per
response for each submission is based on the estimated time that it
takes to prepare a supplement to an application, which may be
considered similar to a request for an exception or alternative. To the
extent that labeling changes not already required by FDA regulations
are made in connection with an exception or alternative granted under
the regulations, FDA is estimating one occurrence annually in the event
FDA would require any additional labeling changes not already covered
by FDA regulations. FDA estimates 8 hours to develop and revise the
labeling to make such changes. The average burden per response for each
submission is based on the estimated time to develop and revise the
labeling to make such changes.
In the Federal Register of May 23, 2017 (82 FR 23584), we published
a 60-day notice requesting public comment on the proposed extension of
this collection of information. No comments were received.
We therefore estimate the burden of this collection of information
as follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average burden
21 CFR Section Number of responses per Total annual per response Total hours
respondents respondent responses (in hours)
----------------------------------------------------------------------------------------------------------------
201.26(b)(1)(i), 1 1 1 24 24
610.68(b)(1)(i),
801.128(b)(1)(i), and
809.11(b)(1)(i)................
201.26(b)(1)(i), 1 1 1 8 8
610.68(b)(1)(i),
801.128(b)(1)(i), and
809.11(b)(1)(i)................
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 32
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
[[Page 37103]]
Dated: August 2, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-16648 Filed 8-7-17; 8:45 am]
BILLING CODE 4164-01-P