Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request, 31947-31949 [2016-11869]
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Federal Register / Vol. 81, No. 98 / Friday, May 20, 2016 / Notices
The meeting will be held on June
20, 2016, from 9:30 a.m. to 1 p.m.
ADDRESSES: FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm.
1503), Silver Spring, MD, 20993–0002.
Answers to commonly asked questions
including information regarding special
accommodations due to a disability,
visitor parking, and transportation may
be accessed at: https://www.fda.gov/
AdvisoryCommittees/AboutAdvisory
Committees/ucm408555.htm. For those
unable to attend in person, the meeting
will also be Webcast and will be
available at the following link: https://
collaboration.fda.gov/bpac2016/.
FOR FURTHER INFORMATION CONTACT:
Bryan Emery or Joanne Lipkind,
Division of Scientific Advisors and
Consultants, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 6132,
Silver Spring, MD 20993–0002, 240–
402–8054, bryan.emery@fda.hhs.gov,
and 240–402–8106, joanne.lipkind@
fda.hhs.gov, respectively; or FDA
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gov/AdvisoryCommittees/default.htm
and scroll down to the appropriate
advisory committee meeting link, or call
the advisory committee information line
to learn about possible modifications
before coming to the meeting.
SUPPLEMENTARY INFORMATION:
Agenda: On June 20, 2016, the
Committee members will participate in
the meeting via teleconference. In open
session, the Committee will discuss the
research programs in the Laboratory of
Plasma Derivatives in the Division of
Hematology Research and Review,
Office of Blood Research and Review,
Center for Biologics Evaluation and
Research, FDA.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its Web site prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s Web site after
the meeting. Background material is
available at https://www.fda.gov/
AdvisoryCommittees/Calendar/
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DATES:
VerDate Sep<11>2014
17:40 May 19, 2016
Jkt 238001
default.htm. Scroll down to the
appropriate advisory committee meeting
link.
Procedure: On June 20, 2016, from
9:30 a.m. to 12:20 p.m., the meeting is
open to the public. Interested persons
may present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
person on or before June 6, 2016. Oral
presentations from the public will be
scheduled between approximately 11:20
a.m. to 12:20 p.m. on June 20, 2016.
Those individuals interested in making
formal oral presentations should notify
the contact person and submit a brief
statement of the general nature of the
evidence or arguments they wish to
present, the names and addresses of
proposed participants, and an
indication of the approximate time
requested to make their presentation on
or before June 3, 2016. Time allotted for
each presentation may be limited. If the
number of registrants requesting to
speak is greater than can be reasonably
accommodated during the scheduled
open public hearing session, FDA may
conduct a lottery to determine the
speakers for the scheduled open public
hearing session. The contact person will
notify interested persons regarding their
request to speak by June 6, 2016.
Closed Committee Deliberations: On
June 20, 2016, from 12:20 p.m. to 1 p.m.,
the meeting will be closed to the public
to permit discussion where disclosure
would constitute a clearly unwarranted
invasion of personal privacy (5 U.S.C.
552b(c)(6)). The Committee will discuss
the site visit report of the intramural
research programs and make
recommendations regarding personnel
staffing decisions.
Persons attending FDA’s advisory
committee meetings are advised that the
Agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with disabilities.
If you require accommodations due to a
disability, please contact Bryan Emery
at least 7 days in advance of the
meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our Web site at
https://www.fda.gov/Advisory
Committees/AboutAdvisoryCommittees/
ucm111462.htm for procedures on
public conduct during advisory
committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
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31947
Dated: May 16, 2016.
Jill Hartzler Warner,
Associate Commissioner for Special Medical
Programs.
[FR Doc. 2016–11854 Filed 5–19–16; 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
Health Resources and Services
Administration, HHS.
ACTION: Notice.
AGENCY:
In compliance with Section
3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the Health
Resources and Services Administration
(HRSA) has submitted an Information
Collection Request (ICR) to the Office of
Management and Budget (OMB) for
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 June 20, 2016.
ADDRESSES: Submit your comments,
including the Information Collection
Request 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.
SUMMARY:
Information Collection Request Title:
340B Drug Pricing Program Reporting
Requirements OMB No. 0915–0176—
[Revision]
Abstract: Section 602 of Public Law
102–585, the Veterans Health Care Act
of 1992, enacted section 340B of the
Public Health Service Act (PHS Act)
‘‘Limitation on Prices of Drugs
Purchased by Covered Entities.’’ Section
340B provides that a manufacturer who
participates in Medicaid must sign a
Pharmaceutical Pricing Agreement with
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31948
Federal Register / Vol. 81, No. 98 / Friday, May 20, 2016 / Notices
the Secretary of Health and Human
Services in which the manufacturer
agrees to charge enrolled covered
entities a price for covered outpatient
drugs that will not exceed an amount
determined under a statutory formula.
Covered entities who choose to
participate in the section 340B Drug
Pricing Program must comply with the
requirements of 340B(a)(5) of the PHS
Act. Section 340B(a)(5)(A) prohibits a
covered entity from requesting Medicaid
reimbursement from a drug that has
been discounted under the 340B
Program. Further, section 340B(a)(5)(B)
prohibits a covered entity from reselling
or otherwise transferring a discounted
drug to a person who is not a patient of
the entity.
Section 340B(a)(5)(C) of the PHS Act
permits the Secretary and manufacturers
of a covered outpatient drug to conduct
audits of covered entities in accordance
with procedures established by the
Secretary related to the number,
duration, and scope of the audits.
Manufacturers are permitted to conduct
an audit only when there is reasonable
cause to believe a violation of section
340B(a)(5)(A) or (B) has occurred. The
manufacturer notifies the covered entity
in writing when it believes the covered
entity has violated these provisions of
the 340B Program. If the problem cannot
be resolved, the manufacturer will then
submit an audit work plan describing
the audit and evidence in support of the
reasonable cause standard to HRSA,
Healthcare Systems Bureau, Office of
Pharmacy Affairs (OPA) for review.
OPA will review the documentation to
determine if reasonable cause exists.
Once the audit is complete, the
manufacturer will submit copies of the
audit report to OPA for review and
resolution of the findings, as
appropriate. The manufacturer will also
submit an informational copy of the
audit report to the Health and Human
Services (HHS) Office of Inspector
General (OIG).
In response to the statutory mandate
of section 340B(a)(5)(C) to permit the
Secretary or manufacturers to conduct
audits of covered entities and because of
the potential for disputes involving
covered entities and participating drug
manufacturers, OPA developed an
informal voluntary dispute resolution
process for manufacturers and covered
entities who, prior to filing a request for
resolution of a dispute with OPA,
should attempt in good faith to resolve
the dispute. All parties involved in the
dispute should maintain written
documentation as evidence of a good
faith attempt to resolve the dispute. To
request voluntary dispute resolution of
an unresolved dispute, a party submits
a written request for a review of the
dispute to OPA. A committee appointed
to review the documentation will send
a letter to the party alleged to have
committed a violation. The party will be
asked to provide a response to or a
rebuttal of the allegations.
HRSA published a notice in 1996 and
a policy release in 2011 on
manufacturer audit guidelines and the
informal dispute resolution process (61
FR 65406 (December 12, 1996) and
‘‘Clarification of Manufacturer Audits of
340B Covered Entities,’’ Release No.
2011–3).
The revision to this package includes
additional background information on
the dispute resolution process and
clarifies the need and proposed use of
information regarding the manufacturer
audit guidelines and the informal
dispute resolution process.
HHS has reviewed all comments
submitted in response to the publication
of a 60-day Federal Register notice
requesting comments on this ICR.
Comments submitted included requests
for standardized reporting forms.
Commenters also expressed concern
that burden hours were significantly
understated. HHS agrees that the
burdens associated with this ICR may
have been understated. Adjusted burden
estimates are included in this 30-day
notice. Finally, HHS appreciates the
comments received regarding the
development of a formal dispute
resolution process. HHS is in the
process of developing a regulation to
establish and implement a binding
administrative dispute resolution
process pursuant to section 340(d)(3) of
the PHS Act. Some of the comments
received regarding the audit process are
beyond the scope of this notice, and as
such, HHS will not be addressing them
in this notice.
Need and Proposed Use of the
Information: HRSA is proposing the
collection of information related to the
manufacturer audit guidelines. These
guidelines contain the following
reporting/notification elements:
1. Manufacturers should notify the
entity in writing when it believes a
violation has occurred;
2. manufacturers should submit
documentation to OPA as evidence of
good faith of attempts to resolve a
dispute;
3. manufacturers must submit an
audit work plan to OPA;
4. manufacturers should submit the
audit report to OPA and informational
copies to the HHS OIG; and
5. the covered entity should provide
a written response to the audit report.
This information is necessary to
ensure the orderly conduct of
manufacturer audits. In addition, the
informal dispute resolution process
requires the participating manufacturer
or covered entity requesting dispute
resolution to provide OPA with a
written request. The party alleged to
have committed a section 340B
violation may provide a response or
rebuttal to OPA. This information is
necessary to ensure that the dispute will
be resolved in a fair and equitable
manner.
Likely Respondents: Drug
manufacturers and 340B covered
entities.
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.
mstockstill on DSK3G9T082PROD with NOTICES
TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS
Number of
respondents
Form name
Number of
responses per
respondent
Total
responses
Average
burden per
response
(in hours)
Total burden
hours
Audits
Resolution 1
Good faith
........................................................
Audit Notification to Entity 1 .................................................
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17:40 May 19, 2016
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10
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1
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10
10
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60
6
600
60
31949
Federal Register / Vol. 81, No. 98 / Friday, May 20, 2016 / Notices
TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS—Continued
Number of
respondents
Form name
Audit Workplan 1 ..................................................................
Audit Report 1 .......................................................................
Entity Response ...................................................................
Number of
responses per
respondent
40
8
8
Average
burden per
response
(in hours)
Total
responses
Total burden
hours
1
1
1
18
8
8
12
12
12
216
96
96
4
1
........................
40
10
104
15
28
........................
600
280
1948
Recordkeeping requirement
Number of
recordkeepers
Hours of
recordkeeping
Total burden
Dispute Records ..........................................................................................................................
50
1
50
Dispute Resolution
Dispute Request ..................................................................
Rebuttal ................................................................................
Total ..............................................................................
1 Prepared
10
10
96
by the manufacturer.
Recordkeeping Burden:
Jason E. Bennett,
Director, Division of the Executive Secretariat.
[FR Doc. 2016–11869 Filed 5–19–16; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Maternal and Child Health
Collaborative Office Rounds
Health Resources and Services
Administration, HHS.
ACTION: Notice of a class deviation from
competition requirements for Maternal
and Child Health Collaborative Office
Rounds.
AGENCY:
HRSA announces the award
of an extension in the amount of
$150,000 for the Maternal and Child
Health Collaborative Office Rounds
SUMMARY:
(MCH–COR) grants. The purpose of the
program is to foster joint pediatricschild psychiatry continuing education
in the psychosocial development
aspects of child health, utilizing a study
group approach that emphasizes the
practical challenges confronted by
community based practitioners. The
extension will permit recipients to
continue activities within the scope of
the current award while the program is
evaluated, during the budget period of
7/1/2016–6/30/2017.
FOR FURTHER INFORMATION CONTACT: Rita
Maldonado, Division of Maternal Child
Health Workforce Development,
Maternal and Child Health Bureau,
Health Resources and Services
Administration, 5600 Fishers Lane,
Room 18W13A, Rockville, MD 20852,
Phone: 301.443.3622, Email:
RMaldonado@hrsa.gov.
SUPPLEMENTARY INFORMATION:
Intended Recipient of the Award:
Children’s Research Institute, Johns
mstockstill on DSK3G9T082PROD with NOTICES
Authority: Social Security Act, Title V,
Section 502(a)(1)
Justification: MCHB is requesting a
one-time extension to continue
activities while the program is evaluated
to determine future activities using the
COR model. MCHB will evaluate the
basic structure of the COR model,
identify gaps, and propose possible
enhancements to the model.
Revised
project end
date
FY 2015
authorized
funding level
FY 2016
estimated
funding level
Current project
end date
DC
7/1/2011
6/30/2016
6/30/2017
$15,000
$15,000
T20MC07472
T20MC07464
T20MC21951
OH
MD
NY
7/1/2011
7/1/2011
7/1/2011
6/30/2016
6/30/2016
6/30/2016
6/30/2017
6/30/2017
6/30/2017
15,000
15,000
14,999
15,000
15,000
14,999
T20MC07469
MN
7/1/2011
6/30/2016
6/30/2017
15,000
15,000
T20MC21952
CA
7/1/2011
6/30/2016
6/30/2017
15,000
15,000
T20MC07463
MI
7/1/2011
6/30/2016
6/30/2017
15,000
15,000
T20MC07473
NH
7/1/2011
6/30/2016
6/30/2017
15,000
15,000
T20MC25634
IL
7/1/2011
6/30/2016
6/30/2017
14,859
14,859
Grant No.
CHILDREN’S RESEARCH INSTITUTE.
Children’s Research Institute ......
JOHNS HOPKINS UNIVERSITY
NEW
YORK
UNIVERSITY
SCHOOL OF MEDICINE.
Regents of the University of Minnesota.
The Regents of the University of
California, San Francisco.
THE REGENTS OF THE UNIVERSITY OF MICHIGAN.
TRUSTEES OF DARTMOUTH
COLLEGE.
UNIVERSITY OF ILLINOIS .........
T20MC21950
17:40 May 19, 2016
CFDA Number: 93.110
Current project
start date
Grant recipient/organization name
VerDate Sep<11>2014
Hopkins University, New York School
of Medicine, Regents of the University
of Minnesota, The Regents of the
University of California, San Francisco.
The Regents of the University of
Michigan, Trustees of Dartmouth
College, University of Illinois, Yale
University.
Amount of Each Non-Competitive
Awards: $15,000.
Period of Supplemental Funding: 7/1/
2016–6/30/2017.
Jkt 238001
State
PO 00000
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20MYN1
]]>Agencies
[Federal Register Volume 81, Number 98 (Friday, May 20, 2016)]
[Notices]
[Pages 31947-31949]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-11869]
-----------------------------------------------------------------------
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
AGENCY: Health Resources and Services Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the Health Resources and Services Administration
(HRSA) has submitted an Information Collection Request (ICR) to the
Office of Management and Budget (OMB) for 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 June 20,
2016.
ADDRESSES: Submit your comments, including the Information Collection
Request 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.
Information Collection Request Title: 340B Drug Pricing Program
Reporting Requirements OMB No. 0915-0176--[Revision]
Abstract: Section 602 of Public Law 102-585, the Veterans Health
Care Act of 1992, enacted section 340B of the Public Health Service Act
(PHS Act) ``Limitation on Prices of Drugs Purchased by Covered
Entities.'' Section 340B provides that a manufacturer who participates
in Medicaid must sign a Pharmaceutical Pricing Agreement with
[[Page 31948]]
the Secretary of Health and Human Services in which the manufacturer
agrees to charge enrolled covered entities a price for covered
outpatient drugs that will not exceed an amount determined under a
statutory formula. Covered entities who choose to participate in the
section 340B Drug Pricing Program must comply with the requirements of
340B(a)(5) of the PHS Act. Section 340B(a)(5)(A) prohibits a covered
entity from requesting Medicaid reimbursement from a drug that has been
discounted under the 340B Program. Further, section 340B(a)(5)(B)
prohibits a covered entity from reselling or otherwise transferring a
discounted drug to a person who is not a patient of the entity.
Section 340B(a)(5)(C) of the PHS Act permits the Secretary and
manufacturers of a covered outpatient drug to conduct audits of covered
entities in accordance with procedures established by the Secretary
related to the number, duration, and scope of the audits. Manufacturers
are permitted to conduct an audit only when there is reasonable cause
to believe a violation of section 340B(a)(5)(A) or (B) has occurred.
The manufacturer notifies the covered entity in writing when it
believes the covered entity has violated these provisions of the 340B
Program. If the problem cannot be resolved, the manufacturer will then
submit an audit work plan describing the audit and evidence in support
of the reasonable cause standard to HRSA, Healthcare Systems Bureau,
Office of Pharmacy Affairs (OPA) for review. OPA will review the
documentation to determine if reasonable cause exists. Once the audit
is complete, the manufacturer will submit copies of the audit report to
OPA for review and resolution of the findings, as appropriate. The
manufacturer will also submit an informational copy of the audit report
to the Health and Human Services (HHS) Office of Inspector General
(OIG).
In response to the statutory mandate of section 340B(a)(5)(C) to
permit the Secretary or manufacturers to conduct audits of covered
entities and because of the potential for disputes involving covered
entities and participating drug manufacturers, OPA developed an
informal voluntary dispute resolution process for manufacturers and
covered entities who, prior to filing a request for resolution of a
dispute with OPA, should attempt in good faith to resolve the dispute.
All parties involved in the dispute should maintain written
documentation as evidence of a good faith attempt to resolve the
dispute. To request voluntary dispute resolution of an unresolved
dispute, a party submits a written request for a review of the dispute
to OPA. A committee appointed to review the documentation will send a
letter to the party alleged to have committed a violation. The party
will be asked to provide a response to or a rebuttal of the
allegations.
HRSA published a notice in 1996 and a policy release in 2011 on
manufacturer audit guidelines and the informal dispute resolution
process (61 FR 65406 (December 12, 1996) and ``Clarification of
Manufacturer Audits of 340B Covered Entities,'' Release No. 2011-3).
The revision to this package includes additional background
information on the dispute resolution process and clarifies the need
and proposed use of information regarding the manufacturer audit
guidelines and the informal dispute resolution process.
HHS has reviewed all comments submitted in response to the
publication of a 60-day Federal Register notice requesting comments on
this ICR. Comments submitted included requests for standardized
reporting forms. Commenters also expressed concern that burden hours
were significantly understated. HHS agrees that the burdens associated
with this ICR may have been understated. Adjusted burden estimates are
included in this 30-day notice. Finally, HHS appreciates the comments
received regarding the development of a formal dispute resolution
process. HHS is in the process of developing a regulation to establish
and implement a binding administrative dispute resolution process
pursuant to section 340(d)(3) of the PHS Act. Some of the comments
received regarding the audit process are beyond the scope of this
notice, and as such, HHS will not be addressing them in this notice.
Need and Proposed Use of the Information: HRSA is proposing the
collection of information related to the manufacturer audit guidelines.
These guidelines contain the following reporting/notification elements:
1. Manufacturers should notify the entity in writing when it
believes a violation has occurred;
2. manufacturers should submit documentation to OPA as evidence of
good faith of attempts to resolve a dispute;
3. manufacturers must submit an audit work plan to OPA;
4. manufacturers should submit the audit report to OPA and
informational copies to the HHS OIG; and
5. the covered entity should provide a written response to the
audit report.
This information is necessary to ensure the orderly conduct of
manufacturer audits. In addition, the informal dispute resolution
process requires the participating manufacturer or covered entity
requesting dispute resolution to provide OPA with a written request.
The party alleged to have committed a section 340B violation may
provide a response or rebuttal to OPA. This information is necessary to
ensure that the dispute will be resolved in a fair and equitable
manner.
Likely Respondents: Drug manufacturers and 340B covered entities.
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 Average burden
Form name Number of responses per Total per response Total burden
respondents respondent responses (in hours) hours
----------------------------------------------------------------------------------------------------------------
Audits
----------------------------------------------------------------------------------------------------------------
Good faith Resolution \1\....... 10 1 10 60 600
Audit Notification to Entity \1\ 10 1 10 6 60
[[Page 31949]]
Audit Workplan \1\.............. 40 1 18 12 216
Audit Report \1\................ 8 1 8 12 96
Entity Response................. 8 1 8 12 96
----------------------------------------------------------------------------------------------------------------
Dispute Resolution
----------------------------------------------------------------------------------------------------------------
Dispute Request................. 10 4 40 15 600
Rebuttal........................ 10 1 10 28 280
Total....................... 96 .............. 104 .............. 1948
----------------------------------------------------------------------------------------------------------------
\1\ Prepared by the manufacturer.
Recordkeeping Burden:
----------------------------------------------------------------------------------------------------------------
Number of Hours of
Recordkeeping requirement recordkeepers recordkeeping Total burden
----------------------------------------------------------------------------------------------------------------
Dispute Records.............................................. 50 1 50
----------------------------------------------------------------------------------------------------------------
Jason E. Bennett,
Director, Division of the Executive Secretariat.
[FR Doc. 2016-11869 Filed 5-19-16; 8:45 am]
BILLING CODE 4165-15-P
