31790
`
`Federal Register / Vol. 75, No. 107 / Friday, June 4, 2010 / Notices
`
`Dated: May 28, 2010.
`Martique Jones,
`Director, Regulations Development Division-
`B, 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
`AGENCY: 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
`
`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 http://www.cms.hhs.gov/
`PaperworkReductionActof1995, or E-
`mail 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 http://
`www.regulations.gov. Follow the
`instructions for ‘‘Comment or
`
`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 Division-
`B, 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.
`
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`Federal Register / Vol. 75, No. 107 / Friday, June 4, 2010 / Notices
`
`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 (§ 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
`
`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
`
`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 888-
`mel 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, 888-
`mel 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.
`
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