Compliance Policy Guide Sec. 253.100-Use of Units of Plasma and Fresh Frozen Plasma Which Have Been Thawed; Withdrawal of Compliance Policy Guide, 43888-43889 [2013-17531]
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Federal Register / Vol. 78, No. 140 / Monday, July 22, 2013 / Notices
across different financing and delivery
models (e.g., managed care and fee-forservice) and population groups (e.g.,
beneficiaries with physical, mental or
both physical and mental disabilities,
dually eligible beneficiaries, all other
beneficiaries). The survey will serve as
baseline information on the experiences
of low-income adults during the early
stages of implementation of the
Affordable Care Act provision that
permits states to expand eligibility to
adults with income below 138 percent
of the federal poverty level who were
not previously eligible. Along with
states, we can use the survey
information as one indicator of the
quality of care within and across states.
It also will be used to assist us along
with the states in efforts to provide
better care and more affordable care to
Medicaid beneficiaries. Form Number:
CMS–10493 (OCN: 0938–New);
Frequency: Once; Affected Public:
Individuals and households; Number of
Respondents: 1,500,000; Total Annual
Responses: 510,000. Total Annual
Hours: 170,000. (For policy questions
regarding this collection contact Marsha
Lillie-Blanton at 410–786–8856.).
2. Type of Information Collection
Request: New collection (request for a
new OMB control number); Title of
Information Collection: Registration,
Attestation, Dispute & Resolution,
Assumptions Document and Data
Retention Requirements for Open
Payments; Use: Section 6002 of the
Affordable Care Act added section
1128G to the Social Security Act (Act),
which requires applicable
manufacturers and applicable group
purchasing organizations (GPOs) of
covered drugs, devices, biologicals, or
medical supplies to report annually to
CMS certain payments or other transfers
of value to physicians and teaching
hospitals, as well as, certain information
regarding the ownership or investment
interests held by physicians or their
immediate family members in
applicable manufacturers or applicable
GPOs.
Specifically, applicable manufacturers
of covered drugs, devices, biologicals,
and medical supplies are required to
submit on an annual basis the
information required in section
1128G(a)(1) of the Act about certain
payments or other transfers of value
made to physicians and teaching
hospitals (collectively called covered
recipients) during the course of the
preceding calendar year. Similarly,
section 1128G(a)(2) of the Act requires
applicable manufacturers and
applicable GPOs to disclose any
ownership or investment interests in
such entities held by physicians or their
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immediate family members, as well as
information on any payments or other
transfers of value provided to such
physician owners or investors.
Applicable manufacturers must report
the required payment and other transfer
of value information annually to CMS in
an electronic format. The statute also
provides that applicable manufacturers
and applicable GPOs must report
annually to CMS the required
information about physician ownership
and investment interests, including
information on any payments or other
transfers of value provided to physician
owners or investors, in an electronic
format by the same date. Applicable
manufacturers and applicable GPOs are
subject to civil monetary penalties
(CMPs) for failing to comply with the
reporting requirements of the statute.
We are required by statute to publish
the reported data on a public Web site.
The data must be downloadable, easily
searchable, and aggregated. In addition,
we must submit annual reports to the
Congress and each state summarizing
the data reported. Finally, section
1128G of the Act generally preempts
state laws that require disclosure of the
same type of information by
manufacturers.
We published a final rule in 2013 to
implement this program, which
included several information collections
subject to the Paperwork Reduction Act.
This information collection request is to
inform the public about information
collected that is necessary for
registration, attestation, dispute
resolution and corrections, record
retention, and submitting an
assumptions document within Open
Payments. Form Number: CMS–10495
(OCN: 0938–New); Frequency: Once;
Affected Public: Private sector—
Business or other for-profits; Number of
Respondents: 451,582; Total Annual
Responses: 451,582. Total Annual
Hours: 949,005. (For policy questions
regarding this collection contact Melissa
Heesters at 410–786–0618.).
Dated: July 16, 2013.
Martique Jones,
Deputy Director, Regulations Development
Group, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2013–17476 Filed 7–19–13; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–D–0838]
Compliance Policy Guide Sec.
253.100—Use of Units of Plasma and
Fresh Frozen Plasma Which Have
Been Thawed; Withdrawal of
Compliance Policy Guide
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; withdrawal.
The Food and Drug
Administration (FDA) is announcing the
withdrawal of the compliance policy
guide (CPG) entitled ‘‘Sec. 253.100—Use
of Units of Plasma and Fresh Frozen
Plasma Which Have Been Thawed,’’
issued October 1, 1980, and revised in
March 1995.
DATES: The withdrawal is effective July
22, 2013.
FOR FURTHER INFORMATION CONTACT:
Robert L. Hummel, Medical Products
and Tobacco Policy Staff, Office of
Policy and Risk Management, Office of
Regulatory Affairs, Food and Drug
Administration, 12420 Parklawn Dr.,
Rockville, MD 20857, 301–796–4510.
SUPPLEMENTARY INFORMATION: FDA
issued the CPG entitled ‘‘Sec. 253.100—
Use of Units of Plasma and Fresh Frozen
Plasma Which Have Been Thawed’’ on
October 1, 1980, and revised it in March
1995. FDA originally issued CPG Sec.
253.100 to provide FDA’s current
thinking regarding the time limits for
when thawed frozen plasma should be
used for transfusion. At the time of
issuance of the CPG, 21 CFR
606.122(m)(3) provided that the
instruction circular shall include, when
applicable, instructions to begin
administration of the product within 6
hours after thawing. The CPG noted a
planned regulatory change that would
allow greater flexibility in the time of
administration requirements for frozen
plasma products.
In a final rule published in the
Federal Register on January 3, 2012 (77
FR 7), with an effective date of July 2,
2012, FDA modified the time limits
contained in the instruction circular for
when administration of thawed frozen
plasma products begins, as required by
21 CFR 606.122(m)(3), to ‘‘within a
specified time after thawing.’’ As noted
in the preamble to the final rule, the
change was made ‘‘to provide industry
with increased flexibility for developing
and specifying timeframes for which
thawed plasma components can still be
used for transfusion if stored at
SUMMARY:
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Federal Register / Vol. 78, No. 140 / Monday, July 22, 2013 / Notices
appropriate temperatures per industry
standards.’’ (See 77 FR 7 at 14). With
this regulatory change, CPG Sec.
253.100 is obsolete.
FDA is therefore withdrawing CPG
253.100, in its entirety, to eliminate the
obsolete compliance policy.
Dated: July 16, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–17531 Filed 7–19–13; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0001]
Synergizing Efforts in Standards
Development for Cellular Therapies
and Regenerative Medicine Products;
Public Workshop
AGENCY:
Food and Drug Administration,
HHS.
tkelley on DSK3SPTVN1PROD with NOTICES
ACTION:
Notice of public workshop.
The Food and Drug Administration
(FDA), Center for Biologics Evaluation
and Research (CBER), is announcing a
public workshop entitled ‘‘Synergizing
Efforts in Standards Development for
Cellular Therapies and Regenerative
Medicine Products.’’ The purpose of the
public workshop is to bring together a
broad range of stakeholders to discuss
current and future standards
development activities involving
cellular therapies and regenerative
medicine products.
Date and Time: The public workshop
will be held on October 7, 2013, from
8:30 a.m. to 4:30 p.m.
Location: The public workshop will
be held at the FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm.
1503), Silver Spring, MD 20993.
Entrance for the public workshop
participants (non-FDA employees) is
through Building 1 where routine
security check procedures will be
performed. Please visit the following
Web site for location, parking, security,
and travel information: https://
www.fda.gov/AboutFDA/
WorkingatFDA/BuildingsandFacilities/
WhiteOakCampusInformation/
ucm241740.htm.
Contact Person: Sherri Revell, Center
for Biologics Evaluation and Research
(HFM–49), Food and Drug
Administration, 1401 Rockville Pike,
Suite 200N, Rockville, MD 20852–1448,
301–827–2000, FAX: 301–827–3079,
email: CBERPublicEvents@fda.hhs.gov
(Subject line: SESDCTRMP Workshop).
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Registration: Mail or fax your
registration information (including
name, title, firm name, address,
telephone, and fax numbers) to Sherri
Revell (see Contact Person) or email to
CBERPublicEvents@fda.hhs.gov (Subject
line: SESDCTRMP Workshop
Registration) by September 23, 2013.
There is no registration fee for the
public workshop. Early registration is
recommended because seating is
limited. Registration on the day of the
public workshop will be provided on a
space available basis beginning at 7:30
a.m.
Streaming Webcast of the Public
Workshop: For those unable to attend in
person, FDA will Webcast the public
workshop. To join the Webcast of the
public workshop, please go to: https://
collaboration.fda.gov/
sesdctrmpworkshop/. If you have never
attended an Adobe Connect meeting
before, test your connection at https://
collaboration.fda.gov/common/help/en/
support/meeting_test.htm. Get a quick
overview: https://www.adobe.com/go/
connectpro_overview. Registration is not
required for those attending via Adobe
Connect.
If you need special accommodations
due to a disability, please contact Sherri
Revell (see Contact Person) at least 7
days in advance.
SUPPLEMENTARY INFORMATION:
Standardization efforts concerning the
clinical development of cellular
therapies and regenerative medicine
products have generated a great deal of
interest. These efforts include standards
development, expert opinion position
papers, and professional practice
guidelines. However, relatively little is
done to coordinate the various existing
efforts. In the public workshop, FDA
hopes to bring together a broad range of
stakeholders of cellular therapies and
regenerative medicine products in order
to:
• Inform stakeholders about the types
of standards and standards
organizations that are available
currently, the role that the Federal
Agencies play in standards
development, and the potential role that
stakeholders can play in standards
development.
• Provide a high-level overview of
current standards development
activities in the fields of cellular therapy
and regenerative medicine and the
regulatory application of standards.
• Provide opportunity for discussion
of areas of high interest for current or
future standards development in the
fields of cellular therapy and
regenerative medicine and to explore
ways to minimize redundancy and
maximize collaboration.
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43889
We encourage all who have an
interest in the development of cellular
therapies and regenerative medicine
products to attend the public workshop.
Transcripts: Please be advised that as
soon as possible after a transcript of the
public workshop is available, it will be
accessible at: https://www.fda.gov/
BiologicsBloodVaccines/NewsEvents/
WorkshopsMeetingsConferences/
TranscriptsMinutes/default.htm.
Transcripts of the public workshop may
also be requested in writing from the
Division of Freedom of Information
(ELEM–1029), Food and Drug
Administration, 12420 Parklawn Dr.,
Element Bldg., Rockville, MD 20857.
Dated: July 16, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–17528 Filed 7–19–13; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Center for Scientific
Review Special Emphasis Panel;
Developmental Brain Disorders.
Date: July 23, 2013.
Time: 11:00 a.m. to 12:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Telephone Conference Call).
Contact Person: Pat Manos, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5200,
MSC 7846, Bethesda, MD 20892, 301–408–
9866, manospa@csr.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
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]]>Agencies
[Federal Register Volume 78, Number 140 (Monday, July 22, 2013)]
[Notices]
[Pages 43888-43889]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-17531]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-D-0838]
Compliance Policy Guide Sec. 253.100--Use of Units of Plasma and
Fresh Frozen Plasma Which Have Been Thawed; Withdrawal of Compliance
Policy Guide
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; withdrawal.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
withdrawal of the compliance policy guide (CPG) entitled ``Sec.
253.100--Use of Units of Plasma and Fresh Frozen Plasma Which Have Been
Thawed,'' issued October 1, 1980, and revised in March 1995.
DATES: The withdrawal is effective July 22, 2013.
FOR FURTHER INFORMATION CONTACT: Robert L. Hummel, Medical Products and
Tobacco Policy Staff, Office of Policy and Risk Management, Office of
Regulatory Affairs, Food and Drug Administration, 12420 Parklawn Dr.,
Rockville, MD 20857, 301-796-4510.
SUPPLEMENTARY INFORMATION: FDA issued the CPG entitled ``Sec. 253.100--
Use of Units of Plasma and Fresh Frozen Plasma Which Have Been Thawed''
on October 1, 1980, and revised it in March 1995. FDA originally issued
CPG Sec. 253.100 to provide FDA's current thinking regarding the time
limits for when thawed frozen plasma should be used for transfusion. At
the time of issuance of the CPG, 21 CFR 606.122(m)(3) provided that the
instruction circular shall include, when applicable, instructions to
begin administration of the product within 6 hours after thawing. The
CPG noted a planned regulatory change that would allow greater
flexibility in the time of administration requirements for frozen
plasma products.
In a final rule published in the Federal Register on January 3,
2012 (77 FR 7), with an effective date of July 2, 2012, FDA modified
the time limits contained in the instruction circular for when
administration of thawed frozen plasma products begins, as required by
21 CFR 606.122(m)(3), to ``within a specified time after thawing.'' As
noted in the preamble to the final rule, the change was made ``to
provide industry with increased flexibility for developing and
specifying timeframes for which thawed plasma components can still be
used for transfusion if stored at
[[Page 43889]]
appropriate temperatures per industry standards.'' (See 77 FR 7 at 14).
With this regulatory change, CPG Sec. 253.100 is obsolete.
FDA is therefore withdrawing CPG 253.100, in its entirety, to
eliminate the obsolete compliance policy.
Dated: July 16, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-17531 Filed 7-19-13; 8:45 am]
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