Agency Information Collection Activities: Proposed Collection; Public Comment Request, 79915-79917 [2015-32171]
Download as PDF
<![CDATA[
tkelley on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 80, No. 246 / Wednesday, December 23, 2015 / Notices
recent studies conducted by the Public
Health Service and revised the guidance
accordingly. FDA considered several
options to address the comments in
response to the revised MSM donor
deferral policy. Because evidence
indicates that the indefinite deferral
policy for MSM may have become less
effective over time, FDA has determined
that a change in policy is warranted at
this time. Data on the limitations of
nucleic acid tests to identify antibody
negative window period HIV infections
suggests that donor testing alone, absent
any deferral for MSM, would result in
an unacceptable increased risk of
transfusion-transmitted HIV. Similarly,
pretesting at risk donors with a rapid
HIV test prior to donation would be
logistically challenging and would not
necessarily identify newly HIV-infected
individuals. While individual donor
assessment for risk has been
implemented in a few countries, the
implementation of this strategy in the
United States would present significant
practical challenges and currently there
is no validated and accepted individual
risk assessment tool or questionnaire.
Therefore, FDA concluded a time-based
deferral for history of male-male sex is
the most appropriate policy to maintain
the safety of the U.S. blood supply.
Scientific data regarding the
effectiveness of a 1-year deferral in
Australia, a country with similar HIV
epidemiology to the United States,
supports FDA’s policy change to the
blood donor deferral period for MSM
from indefinite deferral to 1 year since
the last sexual contact. Scientifically
robust data are not available for timebased deferrals of less than 1 year. FDA
also concluded that scientific data are
not currently available that would
support revisions to the indefinite
deferral policy for commercial sex
workers or intravenous drug users.
In response to comments, FDA made
the following changes when finalizing
the guidance: (1) Amended the
recommendations regarding the
inclusion of signs and symptoms
associated with HIV in the donor
educational materials; (2) revised the
recommendation for the deferral of
female donors who have had sex with
MSM; (3) stated that FDA no longer
recommends deferral for individuals
who have had sex with an individual
with hemophilia or related clotting
deficiencies requiring treatment with
clotting factor concentrates; and (4)
revised the recommendations regarding
product retrieval and consignee
notification of distributed blood
products collected from a donor who
should have been deferred for HIV risk
VerDate Sep<11>2014
18:05 Dec 22, 2015
Jkt 238001
factors. In addition, FDA made the
following changes to clarify certain
recommendations in the guidance,
which are consistent with current
policy: (1) Clarified that donors who
have been determined to have a falsepositive HIV test may be reentered
according to a requalification method
found acceptable to FDA; (2) noted that
recipients of allogeneic blood
transfusions (i.e., not autologous
transfusions), should be temporarily
deferred; (3) provided reference to an
FDA guidance on the collection of blood
components from donors at risk of HIV
infection; and (4) clarified the deferral
by the responsible physician of a blood
establishment of any donor if the
donation could affect the health of the
donor or the safety of the blood
component. Additionally, the
background section has been expanded
to summarize FDA’s evaluation of the
available policy options under the
available evidence relevant to the MSM
deferral policy. Minor editorial changes
have also been made to the guidance.
FDA remains committed to exploring
options and engaging in public
discussions regarding enhancements to
donor and public education regarding
safe blood donors and evaluating the
effectiveness of the donor history
questionnaire. Further, with the
implementation of a transfusion
transmitted infectious disease
monitoring system, FDA will be able to
monitor donor risk factors and the safety
of the blood supply, as well as
investigate and refine blood safety
measures in the future. FDA’s
recommendations may evolve over time
as new scientific data become available
on strategies to maintain or improve
blood safety.
The guidance announced in this
notice finalizes the draft guidance dated
May 2015 and supersedes the 1992
blood memo.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on recommendations
for reducing the risk of HIV
transmission by blood and blood
products. It does not establish any rights
for any person and is not binding on
FDA or the public. You can use an
alternative approach if it satisfies the
requirements of the applicable statutes
and regulations.
II. Paperwork Reduction Act of 1995
The guidance refers to previously
approved collections of information
found in FDA regulations. These
collections of information are subject to
review by the Office of Management and
PO 00000
Frm 00099
Fmt 4703
Sfmt 4703
79915
Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3520). The collections of information in
21 CFR 601.12 have been approved
under OMB control number 0910–0338;
the collections of information in 21 CFR
606.171 have been approved under
OMB control number 0910–0458; and
the collections of information in 21 CFR
610.46, 630.6, 640.3 and 640.63 have
been approved under OMB control
number 0910–0116.
III. Electronic Access
Persons with access to the Internet
may obtain the guidance at either
https://www.fda.gov/BiologicsBlood
Vaccines/GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm or https://
www.regulations.gov.
Dated: December 17, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–32250 Filed 12–22–15; 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
Health Resources and Services
Administration, HHS.
ACTION: Notice.
AGENCY:
In compliance with the
requirement for opportunity for public
comment on proposed data collection
projects (Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995), the
Health Resources and Services
Administration (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 should be
received no later than February 22,
2016.
SUMMARY:
Submit your comments to
paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance
Officer, Room 10C–16, 5600 Fishers
Lane, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
ADDRESSES:
E:\FR\FM\23DEN1.SGM
23DEN1
79916
Federal Register / Vol. 80, No. 246 / Wednesday, December 23, 2015 / Notices
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
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
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 the HRSA Office of
Pharmacy Affairs (OPA) for review.
OPA will review the documentation to
determine if reasonable cause exists.
Once the audit is completed, 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 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 must maintain written
documentation as evidence of a good
faith attempt to resolve the dispute. If
the dispute is not resolved and dispute
resolution is desired, a party must
submit 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 expected 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.
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 the 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 in order 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 during an audit. 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 for both covered entities
and manufacturers. The total annual
burden hours estimated for this
Information Collection Request are
summarized in the table below.
tkelley on DSK3SPTVN1PROD with NOTICES
TOTAL ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Form name
AUDITS:
Good faith Resolution 1 .................................................
Audit Notification to Entity 1 ..........................................
Audit Workplan 1 ...........................................................
VerDate Sep<11>2014
18:05 Dec 22, 2015
Jkt 238001
PO 00000
Frm 00100
Number of
responses per
respondent
10
10
40
Fmt 4703
Sfmt 4703
Total
responses
1
1
1
E:\FR\FM\23DEN1.SGM
10
10
18
23DEN1
Average
burden per
response
(in hours)
40
4
8
Total burden
hours
400
40
144
79917
Federal Register / Vol. 80, No. 246 / Wednesday, December 23, 2015 / Notices
TOTAL ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Number of
responses per
respondent
Number of
respondents
Form name
Average
burden per
response
(in hours)
Total
responses
Total burden
hours
Audit Report 1 ................................................................
Entity Response ............................................................
DISPUTE RESOLUTION:
Dispute Request ...........................................................
Rebuttal .........................................................................
8
8
1
1
8
8
8
8
64
64
10
10
4
1
40
10
10
16
400
160
Total .......................................................................
96
........................
104
........................
1272
1 Prepared
by the manufacturer.
RECORDKEEPING BURDEN
Recordkeeping
requirement
Number
of recordkeepers
Hours of
recordkeeping
50
0.5
Dispute
Records ......
Total
burden
25
HRSA specifically requests comments
on: (1) The necessity and utility of the
proposed information collection for the
proper performance of the agency’s
functions, (2) the accuracy of the
estimated burden, (3) ways to enhance
the quality, utility, and clarity of the
information to be collected, and (4) the
use of automated collection techniques
or other forms of information
technology to minimize the information
collection burden.
Jackie Painter,
Director, Division of the Executive Secretariat.
[FR Doc. 2015–32171 Filed 12–22–15; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request
Health Resources and Services
Administration, HHS.
ACTION: Notice.
AGENCY:
In compliance with the
requirement for opportunity for public
SUMMARY:
comment on proposed data collection
projects (Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995), the
Health Resources and Services
Administration (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 Information
Collection Request must be received no
later than February 22, 2016.
ADDRESSES: Submit your comments to
paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance
Officer, Room 10–29, Parklawn
Building, 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
information, please include the
information request collection title for
reference.
Information Collection Request Title:
HRSA National Environmental Policy
Act (NEPA) Environmental Information
and Documentation (EID) OMB No.
0915–0324—Extension.
Abstract: HRSA is requesting
extension of the approval for the
Environmental Information and
Documentation (EID) checklist which
Number of
respondents
tkelley on DSK3SPTVN1PROD with NOTICES
Form name
Number of
responses per
respondent
consists of information that the agency
is required to obtain to comply with the
National Environmental Policy Act of
1969 (NEPA). NEPA establishes the
federal government’s national policy for
protection of the environment. HRSA
has developed the EID for applicants of
funding that would potentially impact
the environment and to ensure that their
decision-making processes are
consistent with NEPA.
Need and Proposed Use of the
Information: Applicants must provide
information and assurance of
compliance with NEPA on the EID
checklist. This information is reviewed
in the Pre-Award stage.
Likely Respondents: HRSA applicants
applying for federal construction grants
and cooperative agreements.
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 Information
Collection Request are summarized in
the table below.
Total Estimated Annualized burden
hours:
Total
responses
Average
burden per
response
(in hours)
Total burden
hours
NEPA EID Checklist ............................................................
1,350
1
1,350
1.0
1,350
Total ..............................................................................
1,350
1
1,350
1.0
1,350
VerDate Sep<11>2014
18:05 Dec 22, 2015
Jkt 238001
PO 00000
Frm 00101
Fmt 4703
Sfmt 4703
E:\FR\FM\23DEN1.SGM
23DEN1
]]>Agencies
[Federal Register Volume 80, Number 246 (Wednesday, December 23, 2015)]
[Notices]
[Pages 79915-79917]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-32171]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Proposed Collection;
Public Comment Request
AGENCY: Health Resources and Services Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with the requirement for opportunity for public
comment on proposed data collection projects (Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995), the Health Resources and Services
Administration (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 should be received no later than February
22, 2016.
ADDRESSES: Submit your comments to paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance Officer, Room 10C-16, 5600 Fishers
Lane, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: To request more information on the
proposed project or to obtain a copy of
[[Page 79916]]
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
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 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 the HRSA Office of
Pharmacy Affairs (OPA) for review. OPA will review the documentation to
determine if reasonable cause exists. Once the audit is completed, 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 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 must maintain written documentation
as evidence of a good faith attempt to resolve the dispute. If the
dispute is not resolved and dispute resolution is desired, a party must
submit 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 expected 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.
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 the 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 in
order 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 during an audit. 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 for both covered entities and
manufacturers. The total annual burden hours estimated for this
Information Collection Request 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 40 400
Audit Notification to Entity 10 1 10 4 40
\1\........................
Audit Workplan \1\.......... 40 1 18 8 144
[[Page 79917]]
Audit Report \1\............ 8 1 8 8 64
Entity Response............. 8 1 8 8 64
DISPUTE RESOLUTION:
Dispute Request............. 10 4 40 10 400
Rebuttal.................... 10 1 10 16 160
-------------------------------------------------------------------------------
Total................... 96 .............. 104 .............. 1272
----------------------------------------------------------------------------------------------------------------
\1\ Prepared by the manufacturer.
Recordkeeping Burden
------------------------------------------------------------------------
Number of Hours of Total
Recordkeeping requirement recordkeepers recordkeeping burden
------------------------------------------------------------------------
Dispute Records................ 50 0.5 25
------------------------------------------------------------------------
HRSA specifically requests comments on: (1) The necessity and
utility of the proposed information collection for the proper
performance of the agency's functions, (2) the accuracy of the
estimated burden, (3) ways to enhance the quality, utility, and clarity
of the information to be collected, and (4) the use of automated
collection techniques or other forms of information technology to
minimize the information collection burden.
Jackie Painter,
Director, Division of the Executive Secretariat.
[FR Doc. 2015-32171 Filed 12-22-15; 8:45 am]
BILLING CODE 4165-15-P
