Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Prescription Drug Advertisements, 36799-36801 [2017-16607]
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Federal Register / Vol. 82, No. 150 / Monday, August 7, 2017 / Notices
2. Notification of Results of Tests and
Investigations Regarding or Possibly
Impacting the Product
In the guidance, we recommend the
following for contract manufacturing
arrangements:
• The contract manufacturer should
fully inform the license manufacturer of
the results of all tests and investigations
regarding or possibly having an impact
on the product; and
• The license manufacturer should
obtain assurance from the contractor
that any FDA list of inspectional
observations will be shared with the
license manufacturer to allow
evaluation of its impact on the purity,
potency, and safety of the license
manufacturer’s product.
3. Notification of Products
Manufactured in a Contract Facility
In the guidance, we recommend for
contract manufacturing arrangements
that a license manufacturer cross
reference a contract manufacturing
facility’s master files only in
circumstances involving certain
proprietary information of the contract
manufacturer, such as a list of all
products manufactured in a contract
facility. In this situation, the license
manufacturer should be kept informed
of the types or categories of all products
manufactured in the contract facility.
mstockstill on DSK30JT082PROD with NOTICES
4. Standard Operating Procedures
In the guidance, we remind the
license manufacturer that the license
manufacturer assumes responsibility for
compliance with the applicable product
and establishment standards (21 CFR
600.3(t)). Therefore, if the license
manufacturer enters into an agreement
with a contract manufacturing facility,
the license manufacturer must ensure
that the facility complies with the
applicable standards. An agreement
between a license manufacturer and a
contract manufacturing facility normally
includes procedures to regularly assess
the contract manufacturing facility’s
compliance. These procedures may
include, but are not limited to, review
of records and manufacturing deviations
and defects, and periodic audits.
For shared manufacturing
arrangements, each manufacturer must
submit a separate biologics license
application describing the
manufacturing facilities and operations
applicable to the preparation of that
manufacturer’s biological substance or
product (§ 601.2(a)). In the guidance, we
state that we expect the manufacturer
that prepares, or is responsible for the
preparation of, the product in final form
for commercial distribution to assume
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18:14 Aug 04, 2017
Jkt 241001
primary responsibility for providing
data demonstrating the safety, purity,
and potency of the final product. We
also state that we expect the licensed
finished product manufacturer to be
primarily responsible for any
postapproval obligations, such as
postmarketing clinical trials, additional
product stability studies, complaint
handling, recalls, postmarket reporting
of the dissemination of advertising and
promotional labeling materials as
required under § 601.12(f)(4), and
adverse experience reporting. We
recommend that the final product
manufacturer establish a procedure with
the other participating manufacturer(s)
to obtain information in these areas.
Description of Respondents:
Respondents to the information
collection are participating licensed
manufacturers, final product
manufacturers, and contract
manufacturers associated with
cooperative manufacturing
arrangements subject to the associated
regulations discussed in the guidance.
Burden Estimate: We believe that the
information collection provisions in the
guidance do not create a new burden for
respondents. We believe the reporting
and recordkeeping provisions are part of
usual and customary business practices.
Licensed manufacturers would have
contractual agreements with
participating licensed manufacturers,
final product manufacturers, and
contract manufacturers, as applicable
for the type of cooperative
manufacturing arrangement, to address
all these information collection
provisions.
The guidance also refers to previously
approved collections of information
found in FDA regulations at parts 201,
207, 211, 600, 601, 606, 607, 610, 660,
801, 803, 807, 809, and 820 (21 CFR
parts 201, 207, 211, 600, 601, 606, 607,
610, 660, 801, 803, 807, 809, and 820).
The collections of information in parts
606 and 610 have been approved under
OMB control numbers 0910–0116,
0910–0458, and 0910–0206; part 600
has been approved under OMB control
numbers 0910–0308 and 0910–0458;
parts 601 and 660 have been approved
under OMB control number 0910–0338;
part 803 has been approved under OMB
control number 0910–0437; part 211 has
been approved under OMB control
number 0910–0139; part 820 has been
approved under OMB control number
0910–0073; parts 207, 607, and 807 have
been approved under OMB control
numbers 0910–0045, 0910–0052, and
0910–0625; and parts 201, 801, and 809
have been approved under OMB control
numbers 0910–0537, 0910–0572, and
0910–0485.
PO 00000
Frm 00072
Fmt 4703
Sfmt 4703
36799
Dated: August 2, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–16564 Filed 8–4–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0110]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Prescription Drug
Advertisements
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
6, 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 0910–0686. 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.
SUMMARY:
Prescription Drug Advertisements (OMB
Control Number 0910–0686—Extension)
This information collection supports
Agency regulations. Section 502(n) of
the Federal Food, Drug, and Cosmetic
Act (the FD&C Act) (21 U.S.C. 352(n))
requires that manufacturers, packers,
and distributors (sponsors) who
E:\FR\FM\07AUN1.SGM
07AUN1
36800
Federal Register / Vol. 82, No. 150 / Monday, August 7, 2017 / Notices
advertise prescription human and
animal drugs, including biological
products for humans, disclose in
advertisements certain information
about the advertised product’s uses and
risks. For prescription drugs and
biologics, section 502(n) of the FD&C
Act requires advertisements to contain
‘‘a true statement . . .’’ of certain
information including ‘‘. . . information
in brief summary relating to side effects,
contraindications, and effectiveness
. . .’’ as required by regulations issued
by FDA.
FDA’s prescription drug advertising
regulations at § 202.1 (21 CFR 202.1)
describe requirements and standards for
print and broadcast advertisements.
Section 202.1 applies to advertisements
published in journals, magazines, other
periodicals, and newspapers, and
advertisements broadcast through media
such as radio, television, and telephone
communication systems. Print
advertisements must include a brief
summary of each of the risk concepts
from the product’s approved package
labeling (§ 202.1(e)(1)). Advertisements
that are broadcast through media such
as television, radio, or telephone
communications systems must disclose
the major risks from the product’s
package labeling in either the audio or
audio and visual parts of the
presentation (§ 202.1(e)(1)); this
disclosure is known as the ‘‘major
statement.’’ If a broadcast advertisement
omits the major statement, or if the
major statement minimizes the risks
associated with the use of the drug, the
advertisement could render the drug
misbranded in violation of section
502(n) of the FD&C Act, section 201(n)
of the FD&C Act (21 U.S.C. 321(n)), and
FDA’s implementing regulations at
§ 202.1(e).
Advertisements subject to the
requirements at § 202.1 are subject to
the PRA because these advertisements
disclose information to the public. In
addition, § 202.1(e)(6) and (j) include
provisions that are subject to OMB
approval under the PRA.
Reporting to FDA
Section 202.1(e)(6) permits a person
who would be adversely affected by the
enforcement of a provision of
§ 202.1(e)(6) to request a waiver from
FDA for that provision. The waiver
request must set forth clearly and
concisely the petitioner’s interest in the
advertisement, the specific provision of
§ 202.1(e)(6) from which a waiver is
sought, a complete copy of the
advertisement, and a showing that the
advertisement is not false, lacking in fair
balance, misleading, or otherwise
violative of section 502(n) of the FD&C
Act.
Section 202.1(j), which sets forth
requirements for the dissemination of
advertisements subject to the standards
in § 202.1(e), contains the following
information collection that is subject to
the PRA:
Under § 202.1(j)(1), a sponsor must
submit advertisements to FDA for prior
approval before dissemination if: (1)
The sponsor or FDA has received
information that has not been widely
publicized in medical literature that the
use of the drug may cause fatalities or
serious damage; (2) FDA has notified the
sponsor that the information must be
part of the advertisements for the drug;
and (3) the sponsor has failed to present
to FDA a program for assuring that such
information will be publicized promptly
and adequately to the medical
profession in subsequent
advertisements, or if such a program has
been presented to FDA but is not being
followed by the sponsor.
Under § 202.1(j)(1)(iii), a sponsor
must provide to FDA a program for
assuring that significant new adverse
information about the drug that becomes
known (i.e., use of drug may cause
fatalities or serious damage) will be
publicized promptly and adequately to
the medical profession in any
subsequent advertisements.
Under § 202.1(j)(4), a sponsor may
voluntarily submit advertisements to
FDA for comment prior to publication.
Disclosures to the Public
Under § 202.1, advertisements for
human and animal prescription drug
and biological products must comply
with the standards described in that
section.
Under § 202.1(j)(1), if information that
the use of a prescription drug may cause
fatalities or serious damage has not been
widely publicized in the medical
literature, a sponsor must include such
information in the advertisements for
that drug.
In the Federal Register of May 23,
2017 (82 FR 23574), we published a 60day notice requesting public comment
on the proposed extension of this
collection of information. One comment
was received but did not respond to the
information collection topics solicited
in the notice and therefore we do not
discuss it here.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
responses
per
respondent
Number of
respondents
21 CFR section or activity
Total annual
responses
Hours per
response
Total
hours
CDER
202.1(e)(6); waiver request ..................................................
202.1(j)(1); submission of advertisement ............................
202.1(j)(1)(iii); assuring that adverse information be publicized ................................................................................
202.1(j)(4); voluntary submission of ad to FDA ...................
1
1
1
1
1
1
12
2
12
2
1
71
1
6.97
1
495
12
20
12
9,900
0
0
0
0
0
0
12
2
0
0
0
9
0
8
0
72
12
20
0
1,440
0
0
0
0
12
2
0
0
mstockstill on DSK30JT082PROD with NOTICES
CBER
202.1(e)(6); waiver request ..................................................
202.1(j)(1); submission of advertisement ............................
202.1(j)(1)(iii); assuring that adverse information be publicized ................................................................................
202.1(j)(4); voluntary submission of ad to FDA ...................
CVM
202.1(e)(6); waiver request ..................................................
202.1(j)(1); submission of advertisement ............................
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18:14 Aug 04, 2017
Jkt 241001
PO 00000
Frm 00073
0
0
Fmt 4703
Sfmt 4703
E:\FR\FM\07AUN1.SGM
07AUN1
36801
Federal Register / Vol. 82, No. 150 / Monday, August 7, 2017 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Number of
responses
per
respondent
Number of
respondents
21 CFR section or activity
Total annual
responses
Hours per
response
Total
hours
202.1(j)(1)(iii); assuring that adverse information be publicized ................................................................................
202.1(j)(4); voluntary submission of ad to FDA ...................
0
5
0
1
0
5
12
20
0
100
Total ..............................................................................
........................
........................
........................
........................
11,466
1 There
are no capital costs or operating and maintenance costs associated with this collection.
TABLE 2—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of
respondents
21 CFR section or activity
Number of
disclosures
per
respondent
Total annual
disclosures
Average
burden per
disclosure
Total
hours
CDER
202.1; ad prepared in accordance with part 202 ................
202.1(j)(1); info. included re. fatalities or serious damage ..
394
1
105.3
1
41,494
1
400
40
16,597,600
40
63.4
0
2,984
0
400
40
1,193,600
0
CBER
202.1; ad prepared in accordance with part 202 ................
202.1(j)(1); info. included re. fatalities or serious damage ..
47
0
CVM
202.1; ad prepared in accordance with part 202 ................
202.1(j)(1); info. included re. fatalities or serious damage ..
25
0
36
0
900
0
400
40
360,000
0
Total ..............................................................................
........................
........................
........................
........................
18,151,240
1 There
are no capital costs or operating and maintenance costs associated with this collection.
Dated: August 2, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–16607 Filed 8–4–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission to OMB for
Review and Approval; Public Comment
Request; Information Collection
Request Title: AIDS Drug Assistance
Program Data Report, OMB No. 0915–
0345—Extension
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice
mstockstill on DSK30JT082PROD with NOTICES
AGENCY:
In compliance with the
Paperwork Reduction Act of 1995,
HRSA has submitted an Information
Collection Request (ICR) to the Office of
Management and Budget (OMB) for
SUMMARY:
VerDate Sep<11>2014
18:14 Aug 04, 2017
Jkt 241001
review and approval. Comments
submitted during the first public review
of this ICR will be provided to OMB.
OMB will accept further comments from
the public during the review and
approval period.
DATES: Comments on this ICR should be
received no later than September 6,
2017.
ADDRESSES: Submit your comments,
including the ICR Title, to the desk
officer for HRSA, either by email to
OIRA_submission@omb.eop.gov or by
fax to 202–395–5806.
FOR FURTHER INFORMATION CONTACT: To
request a copy of the clearance requests
submitted to OMB for review, email the
HRSA Information Collection Clearance
Officer at paperwork@hrsa.gov or call
(301) 443–1984.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
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:
AIDS Drug Assistance Program Data
Report OMB No. 0915–0345—
Extension.
PO 00000
Frm 00074
Fmt 4703
Sfmt 4703
Abstract: HRSA’s AIDS Drug
Assistance Program (ADAP) is funded
through the Ryan White HIV/AIDS
Program (RWHAP), Part B, Title XXVI of
the Public Health Service Act, which
provides grants to states and territories.
The ADAP provides medications for the
treatment of HIV. Program funds may
also be used to purchase health
insurance for eligible clients and for
services that enhance access, adherence,
and monitoring of HIV drug treatments.
The following states, territories, and
Pacific Island jurisdictions are eligible
to apply for RWHAP ADAP funding: All
50 states, the District of Columbia, the
Commonwealth of Puerto Rico, the U.S.
Virgin Islands, Guam, American Samoa,
the Commonwealth of the Northern
Mariana Islands, the Republic of Palau,
the Federated States of Micronesia, and
the Republic of the Marshall Islands. As
part of the funding requirements, ADAP
grant recipients submit reports
concerning information on patients
served, eligibility requirements,
pharmaceuticals prescribed, pricing and
other sources of support to provide HIV
medication treatment, cost data, and
coordination with Medicaid. The ADAP
Data Report (ADR) will be submitted
E:\FR\FM\07AUN1.SGM
07AUN1
Agencies
[Federal Register Volume 82, Number 150 (Monday, August 7, 2017)]
[Notices]
[Pages 36799-36801]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-16607]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0110]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Prescription Drug
Advertisements
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 6, 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 0910-0686.
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.
Prescription Drug Advertisements (OMB Control Number 0910-0686--
Extension)
This information collection supports Agency regulations. Section
502(n) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21
U.S.C. 352(n)) requires that manufacturers, packers, and distributors
(sponsors) who
[[Page 36800]]
advertise prescription human and animal drugs, including biological
products for humans, disclose in advertisements certain information
about the advertised product's uses and risks. For prescription drugs
and biologics, section 502(n) of the FD&C Act requires advertisements
to contain ``a true statement . . .'' of certain information including
``. . . information in brief summary relating to side effects,
contraindications, and effectiveness . . .'' as required by regulations
issued by FDA.
FDA's prescription drug advertising regulations at Sec. 202.1 (21
CFR 202.1) describe requirements and standards for print and broadcast
advertisements. Section 202.1 applies to advertisements published in
journals, magazines, other periodicals, and newspapers, and
advertisements broadcast through media such as radio, television, and
telephone communication systems. Print advertisements must include a
brief summary of each of the risk concepts from the product's approved
package labeling (Sec. 202.1(e)(1)). Advertisements that are broadcast
through media such as television, radio, or telephone communications
systems must disclose the major risks from the product's package
labeling in either the audio or audio and visual parts of the
presentation (Sec. 202.1(e)(1)); this disclosure is known as the
``major statement.'' If a broadcast advertisement omits the major
statement, or if the major statement minimizes the risks associated
with the use of the drug, the advertisement could render the drug
misbranded in violation of section 502(n) of the FD&C Act, section
201(n) of the FD&C Act (21 U.S.C. 321(n)), and FDA's implementing
regulations at Sec. 202.1(e).
Advertisements subject to the requirements at Sec. 202.1 are
subject to the PRA because these advertisements disclose information to
the public. In addition, Sec. 202.1(e)(6) and (j) include provisions
that are subject to OMB approval under the PRA.
Reporting to FDA
Section 202.1(e)(6) permits a person who would be adversely
affected by the enforcement of a provision of Sec. 202.1(e)(6) to
request a waiver from FDA for that provision. The waiver request must
set forth clearly and concisely the petitioner's interest in the
advertisement, the specific provision of Sec. 202.1(e)(6) from which a
waiver is sought, a complete copy of the advertisement, and a showing
that the advertisement is not false, lacking in fair balance,
misleading, or otherwise violative of section 502(n) of the FD&C Act.
Section 202.1(j), which sets forth requirements for the
dissemination of advertisements subject to the standards in Sec.
202.1(e), contains the following information collection that is subject
to the PRA:
Under Sec. 202.1(j)(1), a sponsor must submit advertisements to
FDA for prior approval before dissemination if: (1) The sponsor or FDA
has received information that has not been widely publicized in medical
literature that the use of the drug may cause fatalities or serious
damage; (2) FDA has notified the sponsor that the information must be
part of the advertisements for the drug; and (3) the sponsor has failed
to present to FDA a program for assuring that such information will be
publicized promptly and adequately to the medical profession in
subsequent advertisements, or if such a program has been presented to
FDA but is not being followed by the sponsor.
Under Sec. 202.1(j)(1)(iii), a sponsor must provide to FDA a
program for assuring that significant new adverse information about the
drug that becomes known (i.e., use of drug may cause fatalities or
serious damage) will be publicized promptly and adequately to the
medical profession in any subsequent advertisements.
Under Sec. 202.1(j)(4), a sponsor may voluntarily submit
advertisements to FDA for comment prior to publication.
Disclosures to the Public
Under Sec. 202.1, advertisements for human and animal prescription
drug and biological products must comply with the standards described
in that section.
Under Sec. 202.1(j)(1), if information that the use of a
prescription drug may cause fatalities or serious damage has not been
widely publicized in the medical literature, a sponsor must include
such information in the advertisements for that drug.
In the Federal Register of May 23, 2017 (82 FR 23574), we published
a 60-day notice requesting public comment on the proposed extension of
this collection of information. One comment was received but did not
respond to the information collection topics solicited in the notice
and therefore we do not discuss it here.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
21 CFR section or activity Number of responses per Total annual Hours per Total hours
respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
CDER
----------------------------------------------------------------------------------------------------------------
202.1(e)(6); waiver request..... 1 1 1 12 12
202.1(j)(1); submission of 1 1 1 2 2
advertisement..................
202.1(j)(1)(iii); assuring that 1 1 1 12 12
adverse information be
publicized.....................
202.1(j)(4); voluntary 71 6.97 495 20 9,900
submission of ad to FDA........
----------------------------------------------------------------------------------------------------------------
CBER
----------------------------------------------------------------------------------------------------------------
202.1(e)(6); waiver request..... 0 0 0 12 0
202.1(j)(1); submission of 0 0 0 2 0
advertisement..................
202.1(j)(1)(iii); assuring that 0 0 0 12 0
adverse information be
publicized.....................
202.1(j)(4); voluntary 9 8 72 20 1,440
submission of ad to FDA........
----------------------------------------------------------------------------------------------------------------
CVM
----------------------------------------------------------------------------------------------------------------
202.1(e)(6); waiver request..... 0 0 0 12 0
202.1(j)(1); submission of 0 0 0 2 0
advertisement..................
[[Page 36801]]
202.1(j)(1)(iii); assuring that 0 0 0 12 0
adverse information be
publicized.....................
202.1(j)(4); voluntary 5 1 5 20 100
submission of ad to FDA........
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 11,466
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection.
Table 2--Estimated Annual Third-Party Disclosure Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
Number of disclosures Total annual Average
21 CFR section or activity respondents per disclosures burden per Total hours
respondent disclosure
----------------------------------------------------------------------------------------------------------------
CDER
----------------------------------------------------------------------------------------------------------------
202.1; ad prepared in accordance 394 105.3 41,494 400 16,597,600
with part 202..................
202.1(j)(1); info. included re. 1 1 1 40 40
fatalities or serious damage...
----------------------------------------------------------------------------------------------------------------
CBER
----------------------------------------------------------------------------------------------------------------
202.1; ad prepared in accordance 47 63.4 2,984 400 1,193,600
with part 202..................
202.1(j)(1); info. included re. 0 0 0 40 0
fatalities or serious damage...
----------------------------------------------------------------------------------------------------------------
CVM
----------------------------------------------------------------------------------------------------------------
202.1; ad prepared in accordance 25 36 900 400 360,000
with part 202..................
202.1(j)(1); info. included re. 0 0 0 40 0
fatalities or serious damage...
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 18,151,240
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection.
Dated: August 2, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-16607 Filed 8-4-17; 8:45 am]
BILLING CODE 4164-01-P