Determination That Cysteine Hydrochloride Injection, USP, 7.25%, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 31790-31791 [2010-13463]
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31790
Federal Register / Vol. 75, No. 107 / Friday, June 4, 2010 / Notices
Dated: May 28, 2010.
Martique Jones,
Director, Regulations Development DivisionB, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2010–13302 Filed 6–3–10; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–10203]
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Centers for Medicare &
Medicaid Services.
In compliance with the requirement
of section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the
Centers for Medicare & Medicaid
Services (CMS) is publishing the
following summary of proposed
collections for public comment.
Interested persons are invited to send
comments regarding this burden
estimate or any other aspect of this
collection of information, including any
of the following subjects: (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.
1. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
Information Collection: Medicare Health
Outcomes Survey (HOS); Use: CMS has
a responsibility to its Medicare
beneficiaries to require that care
provided by managed care organizations
under contract to CMS is of high
quality. One way of ensuring high
quality care in Medicare Managed Care
Organizations (MCOs), or more
commonly referred to as Medicare
Advantage Organizations (MAOs), is
through the development of
standardized, uniform performance
measures to enable CMS to gather the
data needed to evaluate the care
provided to Medicare beneficiaries.
The goal of the Medicare HOS
program is to gather valid, reliable,
clinically meaningful health status data
in Medicare managed care for use in
quality improvement activities, plan
srobinson on DSKHWCL6B1PROD with NOTICES
AGENCY:
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16:01 Jun 03, 2010
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accountability, public reporting, and
improving health. All managed care
plans with Medicare Advantage (MA)
contracts must participate. CMS, in
collaboration with the National
Committee for Quality Assurance
(NCQA), launched the Medicare HOS as
part of the Effectiveness of Care
component of the former Health Plan
Employer Data and Information Set,
now known as the Healthcare
Effectiveness Data and Information Set
(HEDIS®).
The HOS measure was developed
under the guidance of a Technical
Expert Panel comprised of individuals
with specific expertise in the health care
industry and outcomes measurement.
The measure includes the most recent
advances in summarizing physical and
mental health outcomes results and
appropriate risk adjustment techinques.
In addition to health outcomes
measures, the HOS is used to collect the
Management of Urinary Incontinence in
Older Adults, Physical Activity in Older
Adults, Fall Risk Management, and
Osteoporosis Testing in Older Women
HEDIS® measures. The collection of
Medicare HOS is necessary to hold
Medicare managed care contractors
accountable for the quality of care they
are delivering. This reporting
requirement allows CMS to obtain the
information necessary for proper
oversight of the Medicar Advantage
program. Form Number: CMS–10203
(OMB#: 0938–0701; Frequency: Yearly;
Affected Public: Individuals and
households; Number of Respondents:
1,099,560 Total Annual Responses:
1,099,560; Total Annual Hours: 366,520
(For policy questions regarding this
collection contact Chris Haffer at 410–
786–8764. For all other issues call 410–
786–1326.)
To obtain copies of the supporting
statement and any related forms for the
proposed paperwork collections
referenced above, access CMS’ Web Site
at https://www.cms.hhs.gov/
PaperworkReductionActof1995, or Email your request, including your
address, phone number, OMB number,
and CMS document identifier, to
Paperwork@cms.hhs.gov, or call the
Reports Clearance Office on (410) 786–
1326.
In commenting on the proposed
information collections please reference
the document identifier or OMB control
number. To be assured consideration,
comments and recommendations must
be submitted in one of the following
ways by August 3, 2010:
1. Electronically. You may submit
your comments electronically to https://
www.regulations.gov. Follow the
instructions for ‘‘Comment or
PO 00000
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Submission’’ or ‘‘More Search Options’’
to find the information collection
document(s) accepting comments.
2. By regular mail. You may mail
written comments to the following
address: CMS, Office of Strategic
Operations and Regulatory Affairs,
Division of Regulations Development,
Attention: Document Identifier/OMB
Control Number, Room C4–26–05, 7500
Security Boulevard, Baltimore,
Maryland 21244–1850.
Date: May 28, 2010.
Martique Jones,
Director, Regulations Development DivisionB, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2010–13303 Filed 6–3–10; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–P–0278]
Determination That Cysteine
Hydrochloride Injection, USP, 7.25%,
Was Not Withdrawn From Sale for
Reasons of Safety or Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing its
determination that Cysteine
Hydrochloride Injection, USP, 7.25%
(Cysteine HCl), was not withdrawn from
sale for reasons of safety or
effectiveness. This determination will
allow FDA to approve abbreviated new
drug applications (ANDAs) for Cysteine
HCl if all other legal and regulatory
requirements are met.
FOR FURTHER INFORMATION CONTACT:
David Joy, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, rm. 6358, Silver Spring,
MD 20993–0002, 301–796–3601.
SUPPLEMENTARY INFORMATION: In 1984,
Congress enacted the Drug Price
Competition and Patent Term
Restoration Act of 1984 (Public Law 98–
417) (the 1984 amendments), which
authorized the approval of duplicate
versions of drug products approved
under an ANDA procedure. ANDA
applicants must, with certain
exceptions, show that the drug for
which they are seeking approval
contains the same active ingredient in
the same strength and dosage form as
the ‘‘listed drug,’’ which is a version of
the drug that was previously approved.
E:\FR\FM\04JNN1.SGM
04JNN1
srobinson on DSKHWCL6B1PROD with NOTICES
Federal Register / Vol. 75, No. 107 / Friday, June 4, 2010 / Notices
Sponsors of ANDAs do not have to
repeat the extensive clinical testing
otherwise necessary to gain approval of
a new drug application (NDA). The only
clinical data required in an ANDA are
data to show that the drug that is the
subject of the ANDA is bioequivalent to
the listed drug.
The 1984 amendments include what
is now section 505(j)(7) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
355(j)(7)), which requires FDA to
publish a list of all approved drugs.
FDA publishes this list as part of the
‘‘Approved Drug Products With
Therapeutic Equivalence Evaluations,’’
which is known generally as the
‘‘Orange Book.’’ Under FDA regulations,
drugs are removed from the list if the
agency withdraws or suspends approval
of the drug’s NDA or ANDA for reasons
of safety or effectiveness or if FDA
determines that the listed drug was
withdrawn from sale for reasons of
safety or effectiveness (§ 314.162 (21
CFR 314.162)). Under § 314.161(a)(1) (21
CFR 314.161(a)(1)), the agency must
determine whether a listed drug was
withdrawn from sale for reasons of
safety or effectiveness before an ANDA
that refers to that listed drug may be
approved. FDA may not approve an
ANDA that does not refer to a listed
drug.
Cysteine HCl is the subject of NDA
19–523, most recently held by Hospira,
Inc. (Hospira), and initially approved on
October 22, 1986. Cysteine HCl is
indicated for use as an additive to
amino acid solutions to meet the
nutritional requirements of newborn
infants requiring total parenteral
nutrition (TPN) and of adult and
pediatric patients with severe liver
disease who may have impaired
enzymatic processes and require TPN. It
can also be added to amino acid
solutions to provide a more complete
profile of amino acids for protein
synthesis. Hospira notified FDA in a
letter dated May 26, 2005, that it had
not commercially manufactured and
marketed Cysteine HCl, and voluntarily
asked that the NDA be withdrawn. The
drug product was moved to the
‘‘Discontinued Drug Product List’’
section of the Orange Book, and FDA
withdrew approval of NDA 19–523
effective June 16, 2006 (71 FR 34940). In
previous instances (see, e.g., 74 FR
63404, December 3, 2009; 72 FR 9763,
March 5, 2007; 61 FR 25497, May 21,
1996), the agency has determined that,
for purposes of §§ 314.161 and 314.162,
never marketing an approved drug
product is equivalent to withdrawing
the drug from sale. Regulus
Pharmaceutical Consulting, Inc.,
submitted a citizen petition, dated April
VerDate Mar<15>2010
16:01 Jun 03, 2010
Jkt 220001
30, 2008 (Docket No. FDA–2008–P–
0278), under 21 CFR 10.30, requesting
that the agency determine whether
Cysteine HCl was withdrawn from sale
for reasons of safety or effectiveness.
FDA has reviewed its records and,
under § 314.161, has determined that
Cysteine Hydrochloride Injection, USP,
7.25%, was not withdrawn for reasons
of safety or effectiveness. We have also
independently evaluated relevant
literature and have found no
information that would indicate that
this product was withheld from sale for
reasons of safety or effectiveness.
Accordingly, the agency will continue
to list Cysteine Hydrochloride Injection,
USP, 7.25%, in the ‘‘Discontinued Drug
Product List’’ section of the Orange
Book. The ‘‘Discontinued Drug Product
List’’ delineates, among other items,
drug products that have been
discontinued from marketing for reasons
other than safety or effectiveness.
ANDAs that refer to Cysteine
Hydrochloride Injection, USP, 7.25%
may be approved by the agency if all
other legal and regulatory requirements
for the approval of ANDAs are met. If
FDA determines that the labeling for
this drug product should be revised to
meet current standards, the agency will
advise ANDA applicants to submit such
labeling.
Dated: May 27, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–13463 Filed 6–3–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
AGENCY: National Institutes of Health,
Public Health Service, HHS.
ACTION: Notice.
SUMMARY: The inventions listed below
are owned by an agency of the U.S.
Government and are available for
licensing in the United States in
accordance with 35 U.S.C. 207 to
achieve expeditious commercialization
of results of Federally-funded research
and development. Foreign patent
applications are filed on selected
inventions to extend market coverage
for companies and may also be available
for licensing.
ADDRESSES: Licensing information and
copies of the U.S. patent applications
listed below may be obtained by writing
to the indicated licensing contact at the
PO 00000
Frm 00049
Fmt 4703
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31791
Office of Technology Transfer, National
Institutes of Health, 6011 Executive
Boulevard, Suite 325, Rockville,
Maryland 20852–3804; telephone: 301/
496–7057; fax: 301/402–0220. A signed
Confidential Disclosure Agreement will
be required to receive copies of the
patent applications.
888-mel: A Target for Anti-Tumor
Immune Responses
Description of Invention: Scientists at
the National Institutes of Health (NIH)
have developed a human melanoma cell
line designated 888-mel from the
resected tumor of a 26-year old
Caucasian female (patient 888)
diagnosed with metastatic melanoma, a
frequently terminal cancer. The 888-mel
cell line was derived from three separate
subcutaneous melanoma lesions on the
patient and possesses many
characteristics representative of
melanoma cell lines developed by these
researchers. Most prominently, the 888mel cell line was used to develop a
tumor infiltrating lymphocyte (TIL)
culture with high affinity for the tumor
cells of patient 888. When the TIL 888
culture was provided as an autologous
adoptive immunotherapy treatment to
patient 888 in combination with
interleukin-2 (IL–2), a complete
remission of subcutaneous, lung, and
mucosal metastases was observed in the
patient for over three years.
Since this medical breakthrough, the
888-mel cell line has been well
characterized through various laboratory
procedures and data involving this cell
line has been published as part of
numerous articles. Studies have shown
that the cell line expresses a variety of
tumor associated antigens (TAAs),
including tyrosinase, TRP1, TRP2,
gp100, MART–1, p15, gp75, mutated
beta-catenin, and p53. However, 888mel does not normally express the
MAGE 1, 2, or 3 TAAs. Many melanoma
cell lines are HLA–A2 restricted, but the
888-mel cell line is HLA–A2 negative.
The HLA class I typing for this cell line
is as follows: HLA–A0101, A2402, B55,
B62, Cw5201, Cw55, DRbl*1502,
DRbl*1610, DQbl*0601, DRb5*0102,
DRb5*0203. 888-mel is a validated
source of HLA class I peptides utilized
in screens that test the reactivity of TIL
cultures that are candidates for adoptive
immunotherapy trials. 888-mel is also a
standard cell line for studying immune
responses in cancer, particularly T cell
responses. Other experiments show that
roscovitine, a cyclin-dependent kinase
inhibitor, can induce apoptosis in the
888-mel cell line, so these cells may be
useful in various cell death studies.
E:\FR\FM\04JNN1.SGM
04JNN1
]]>Agencies
[Federal Register Volume 75, Number 107 (Friday, June 4, 2010)]
[Notices]
[Pages 31790-31791]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-13463]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-P-0278]
Determination That Cysteine Hydrochloride Injection, USP, 7.25%,
Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing its
determination that Cysteine Hydrochloride Injection, USP, 7.25%
(Cysteine HCl), was not withdrawn from sale for reasons of safety or
effectiveness. This determination will allow FDA to approve abbreviated
new drug applications (ANDAs) for Cysteine HCl if all other legal and
regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT: David Joy, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, rm. 6358, Silver Spring, MD 20993-0002, 301-796-3601.
SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price
Competition and Patent Term Restoration Act of 1984 (Public Law 98-417)
(the 1984 amendments), which authorized the approval of duplicate
versions of drug products approved under an ANDA procedure. ANDA
applicants must, with certain exceptions, show that the drug for which
they are seeking approval contains the same active ingredient in the
same strength and dosage form as the ``listed drug,'' which is a
version of the drug that was previously approved.
[[Page 31791]]
Sponsors of ANDAs do not have to repeat the extensive clinical testing
otherwise necessary to gain approval of a new drug application (NDA).
The only clinical data required in an ANDA are data to show that the
drug that is the subject of the ANDA is bioequivalent to the listed
drug.
The 1984 amendments include what is now section 505(j)(7) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which
requires FDA to publish a list of all approved drugs. FDA publishes
this list as part of the ``Approved Drug Products With Therapeutic
Equivalence Evaluations,'' which is known generally as the ``Orange
Book.'' Under FDA regulations, drugs are removed from the list if the
agency withdraws or suspends approval of the drug's NDA or ANDA for
reasons of safety or effectiveness or if FDA determines that the listed
drug was withdrawn from sale for reasons of safety or effectiveness
(Sec. 314.162 (21 CFR 314.162)). Under Sec. 314.161(a)(1) (21 CFR
314.161(a)(1)), the agency must determine whether a listed drug was
withdrawn from sale for reasons of safety or effectiveness before an
ANDA that refers to that listed drug may be approved. FDA may not
approve an ANDA that does not refer to a listed drug.
Cysteine HCl is the subject of NDA 19-523, most recently held by
Hospira, Inc. (Hospira), and initially approved on October 22, 1986.
Cysteine HCl is indicated for use as an additive to amino acid
solutions to meet the nutritional requirements of newborn infants
requiring total parenteral nutrition (TPN) and of adult and pediatric
patients with severe liver disease who may have impaired enzymatic
processes and require TPN. It can also be added to amino acid solutions
to provide a more complete profile of amino acids for protein
synthesis. Hospira notified FDA in a letter dated May 26, 2005, that it
had not commercially manufactured and marketed Cysteine HCl, and
voluntarily asked that the NDA be withdrawn. The drug product was moved
to the ``Discontinued Drug Product List'' section of the Orange Book,
and FDA withdrew approval of NDA 19-523 effective June 16, 2006 (71 FR
34940). In previous instances (see, e.g., 74 FR 63404, December 3,
2009; 72 FR 9763, March 5, 2007; 61 FR 25497, May 21, 1996), the agency
has determined that, for purposes of Sec. Sec. 314.161 and 314.162,
never marketing an approved drug product is equivalent to withdrawing
the drug from sale. Regulus Pharmaceutical Consulting, Inc., submitted
a citizen petition, dated April 30, 2008 (Docket No. FDA-2008-P-0278),
under 21 CFR 10.30, requesting that the agency determine whether
Cysteine HCl was withdrawn from sale for reasons of safety or
effectiveness.
FDA has reviewed its records and, under Sec. 314.161, has
determined that Cysteine Hydrochloride Injection, USP, 7.25%, was not
withdrawn for reasons of safety or effectiveness. We have also
independently evaluated relevant literature and have found no
information that would indicate that this product was withheld from
sale for reasons of safety or effectiveness. Accordingly, the agency
will continue to list Cysteine Hydrochloride Injection, USP, 7.25%, in
the ``Discontinued Drug Product List'' section of the Orange Book. The
``Discontinued Drug Product List'' delineates, among other items, drug
products that have been discontinued from marketing for reasons other
than safety or effectiveness. ANDAs that refer to Cysteine
Hydrochloride Injection, USP, 7.25% may be approved by the agency if
all other legal and regulatory requirements for the approval of ANDAs
are met. If FDA determines that the labeling for this drug product
should be revised to meet current standards, the agency will advise
ANDA applicants to submit such labeling.
Dated: May 27, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-13463 Filed 6-3-10; 8:45 am]
BILLING CODE 4160-01-S
