Department of Health and Human Services February 2009 – Federal Register Recent Federal Regulation Documents
Results 151 - 200 of 269
Agency Information Collection Activities; Proposed Collection; Comment Request; Irradiation in the Production, Processing, and Handling of Food
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection provisions of FDA's requirements for food irradiation processors. This notice also notifies the public of and solicits comments on FDA's proposal to transfer the collection of information and associated burden hours from the Office of Management and Budget (OMB) control number 0910-0549 to the subject collection of information (OMB control number 0910-0186).
Draft Guidance for Industry on Process Validation: General Principles and Practices; Reopening of Comment Period
The Food and Drug Administration (FDA) is reopening until March 16, 2009, the comment period for the draft guidance entitled ``Process Validation: General Principles and Practices.'' FDA announced the availability of this draft guidance in the Federal Register of November 18, 2008 (73 FR 68431). The initial comment period closes on January 20, 2009. FDA is taking this action in response to a request for an extension of the comment period, due to the holiday season, to allow interested persons sufficient time to review this draft guidance and submit comments.
Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting
This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Cardiovascular and Renal Drugs Advisory Committee. General Function of the Committee: To provide advice and recommendations to the agency on FDA's regulatory issues. Date and Time: The meeting will be held on March 19, 2009, from 8 a.m. to 5 p.m. Location: Marriott Conference Centers, UMUC Inn and Conference Center by Marriott, 3501 University Blvd., East, Adelphi, MD. The hotel telephone number is 301-985-7385. Contact Person: Elaine Ferguson, Center for Drug Evaluation and Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane, (for express delivery, 5630 Fishers Lane, rm. 1093), Rockville, MD 20857, 301-827-7001, FAX: 301-827-6776, e-mail: elaine.ferguson@fda.hhs.gov, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014512533. Please call the Information Line for up-to-date information on this meeting. A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the agency's Web site and call the appropriate advisory committee hot line/phone line to learn about possible modifications before coming to the meeting. Agenda: The committee will discuss new drug application (NDA) 22- 406, rivaroxaban oral tablets (10 milligrams) Johnson & Johnson Pharmaceutical Research & Development, L.L.C., for the proposed indication for use in prophylaxis of deep vein thrombosis and pulmonary embolism in patients undergoing hip replacement surgery or knee replacement surgery. 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/ohrms/dockets/ac/acmenu.htm, click on the year 2009 and scroll down to the appropriate advisory committee link. Procedure: 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 March 5, 2009. Oral presentations from the public will be scheduled between approximately 1 p.m. to 2 p.m. Those desiring to make 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 February 25, 2009. 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 February 26, 2009. 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 physical disabilities or special needs. If you require special accommodations due to a disability, please contact Elaine Ferguson 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/oc/advisory/ default.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).
Notice of Availability of Final Policy Guidance
HRSA has issued Policy Information Notice (PIN) 2009-04, ``Revision to PIN 2003-21: Federally Qualified Health Center (FQHC) Look-Alike Guidelines and Application,'' to announce a technical revision to PIN 2003-21: FQHC Look-Alike Guidelines and Application, issued on August 26, 2003. Both PINs are available on HRSA's Web site at https://bphc.hrsa.gov/policy/#lookalikes. Background: HRSA has issued PIN 2009-04, ``Revision to PIN 2003-21: FQHC Look-Alike Guidelines and Application,'' to announce a technical revision to PIN 2003-21: FQHC Look-Alike Guidelines and Application, issued on August 26, 2003. PIN 2003-21 conveys eligibility and compliance requirements of the FQHC Look-Alike Program and instructions for submitting an application for FQHC Look-Alike designation, recertification, and change in scope of project. PIN 2009-04 updates the data submission requirements in PIN 2003-21. Applicants and existing FQHC Look-Alikes should refer to both PINs when preparing applications. Both PINs are available on HRSA's Web site at https:// bphc.hrsa.gov/policy/#lookalikes. PIN 2009-04 reflects the Office of Management and Budget (OMB) approved extension of information collection (control number 0915-0142) to November 30, 2011. Furthermore, the race and ethnicity data is now collected as two separate data elements in Table 2, Part B, to meet OMB Standards for the Classification of Federal Data on Race and Ethnicity as well as Standards for Maintaining, Collecting, and Presenting Federal Data on Race and Ethnicity (62 FR 36874-36946; 62 FR 58781-9; and OMB Bulletin 00-02). Please note that all information provided regarding race and/or ethnicity will be used only to ensure compliance with statutory and regulatory Governing Board requirements set forth in section 330 of the Public Health Service Act. Data on race and/or ethnicity collected on this form will not be used as a factor in recommending approval for FQHC Look-Alike designation, recertification, or change in scope of project. PIN 2009-04 provides more detail regarding this modification as well as new Tables that must be included with all application submissions.
Notice of Availability of Final Policy Guidance
HRSA is publishing a final Agency Guidance (``Policy Information Notice'' (PIN) 2009-02), to describe the policy and processes pertaining to requests from federally-funded health centers to change the scope of their Federal project. The PIN, ``Specialty Services and Health Centers'' Scope of Project,'' and the Agency's ``Response to Public Comments'' are available on the Internet at http:/ /bphc.hrsa.gov.
Meeting of the Secretary's Advisory Committee on Human Research Protections
Pursuant to Section 10(a) of the Federal Advisory Committee Act, U.S.C. Appendix 2, notice is hereby given that the Secretary's Advisory Committee on Human Research Protections (SACHRP) will hold its nineteenth meeting. The meeting will be open to the public.
Meeting of the Advisory Committee on Minority Health
The Department of Health and Human Services published a notice in the Federal Register of February 4, 2009 announcing a February 24, 2009 meeting of the Advisory Committee on Minority Health. It was announced that this meeting would be held at The Westin National Harbor, 171 Waterfront Street, Oxon Hill, MD. Due to unforseen circumstances the location of the meeting has been changed.
Implantation or Injectable Dosage Form New Animal Drugs; Flunixin
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental abbreviated new animal drug application (ANADA) filed by Cross Vetpharm Group Ltd. The supplemental ANADA provides for the veterinary prescription use of flunixin meglumine solution by intravenous injection in dairy cattle for control of pyrexia associated with acute bovine mastitis.
Determination of Regulatory Review Period for Purposes of Patent Extension; MACROPLASTIQUE IMPLANTS
The Food and Drug Administration (FDA) has determined the regulatory review period for MACROPLASTIQUE IMPLANTS and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of Patents and Trademarks, Department of Commerce, for the extension of patents which claim that medical device.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry and Food and Drug Administration Staff; Compliance With the Medical Device User Fee and Modernization Act of 2002, as Amended: Prominent and Conspicuous Mark of Manufacturers on Single-Use Devices (formerly “Reprocessed Single-Use Device Labeling”)
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Apothecon et al.; Withdrawal of Approval of 103 New Drug Applications and 35 Abbreviated New Drug Applications
The Food and Drug Administration (FDA) is withdrawing approval of 103 new drug applications (NDAs) and 35 abbreviated new drug applications (ANDAs) from multiple applicants. The holders of the applications notified the agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
New Animal Drugs; Bc6 Recombinant Deoxyribonucleic Acid Construct
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the original approval of a new animal drug application (NADA) filed by GTC Biotherapeutics, Inc. The NADA provides for use of a recombinant deoxyribonucleic acid (rDNA) construct in a lineage of genetically engineered (GE) goats expressing recombinant human antithrombin in their milk. The subsequently purified antithrombin is a biological product for human therapeutic use. In a separate action, a biologics license application (BLA) has been approved by FDA for use of this antithrombin in humans.
Agency Information Collection Activities; Proposed Collection; Comment Request; Substances Generally Recognized as Safe: Notification Procedure
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection provisions of the Notification Procedure for Substances Generally Recognized as Safe.
Agency Information Collection Activities; Proposed Collection; Comment Request; Investigational New Drug Regulations
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on requirements under which the clinical investigation of the safety and effectiveness of unapproved new drugs and biological products can be conducted.
Request for Nominations for Voting and Nonvoting Consumer Representative Members on Public Advisory Committee and Panels
The Food and Drug Administration (FDA) is requesting nominations for voting and nonvoting consumer representatives to serve on the National Mammography Quality Assurance Advisory Committee (NMQAAC) and certain devices panels of the Medical Devices Advisory Committee in the Center for Devices and Radiological Health (CDRH). FDA has a special interest in ensuring that women, minority groups, and individuals with disabilities are adequately represented on advisory committees and, therefore, encourages nominations of qualified candidates from these groups.
National Toxicology Program (NTP); Report on Carcinogens (RoC); Request for Public Comments on the RoC Expert Panel's Recommendation on Listing Status for Cobalt-Tungsten Carbide Powders and Hard Metals in the 12th RoC and the Scientific Justification for the Recommendation
The NTP invites public comment on the recommendation from an expert panel on the listing status for cobalt-tungsten carbide powders and hard metals in the 12th RoC and the scientific justification for the recommendation. The recommendation and scientific justification for cobalt-tungsten carbide powders and hard metals are available electronically in Part B of the Expert Panel Report (https:// ntp.niehs.nih.gov/go/29682, see Expert Panel Report Part B) or in printed text from the RoC Center (see FOR FURTHER INFORMATION CONTACT below). The RoC Center convened a seven-member expert panel of scientists, plus one technical scientific expert, from the public and private sectors on December 9-10, 2008. The panel was asked (1) to apply the RoC listing criteria to the relevant scientific evidence and make a recommendation regarding listing status (i.e., known to be a human carcinogen, reasonably anticipated to be a human carcinogen, or not to list) for cobalt-tungsten carbide powders and hard metals in the 12th RoC and (2) to provide the scientific justification for the recommendation.
Government-Owned Inventions; Availability for Licensing
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. 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.
Government-Owned Inventions; Availability for Licensing
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. 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.
Government-Owned Inventions; Availability for Licensing
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. 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.
Guidance for Industry: Referral Program From the Food and Drug Administration to the National Oceanic and Atmospheric Administration Seafood Inspection Program for the Certification of Fish and Fishery Products for Export to the European Union and the European Free Trade Association; Availability
The Food and Drug Administration (FDA) is announcing the availability of a revised guidance document entitled ``Guidance for Industry: Referral Program from the Food and Drug Administration to the National Oceanic and Atmospheric Administration Seafood Inspection Program for the Certification of Fish and Fishery Products for Export to the European Union and the European Free Trade Association.'' The revised guidance only changes the date on which FDA intends to stop issuing export certificates for fish or fishery products that are to be shipped to the European Union (EU) and the European Free Trade Association (EFTA). The date FDA now intends to stop issuing EU Export Certificates is June 17, 2009.
Medicare Program; Changes to the Competitive Acquisition of Certain Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) by Certain Provisions of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA)
In accordance with the memorandum of January 20, 2009 from the Assistant to the President and Chief of Staff, entitled ``Regulatory Review,'' CMS is seeking public comment on a contemplated delay of 60 days in the effective date of the rule entitled ``Medicare Program; Changes to the Competitive Acquisition of Certain Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) by Certain Provisions of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA),'' published in the Federal Register on January 16, 2009 (74 FR 2873). That rule implements certain MIPPA provisions that delay implementation of Round 1 of the competitive bidding program; requires CMS to conduct a second Round 1 competition (the ``Round 1 rebid'') in 2009; and mandates certain changes for both the Round 1 rebid and subsequent rounds of the program, including a process for providing feedback to suppliers regarding missing financial documentation and requiring contractors to disclose to CMS information regarding subcontracting relationships. CMS is considering a temporary 60-day delay in effective date to allow CMS officials the opportunity for further review of the issues of law and policy raised by this rule, consistent with the Chief of Staff's memorandum of January 20, 2009. CMS solicits comments specifically on the contemplated delay in effective date and generally on the rule entitled ``Medicare Program; Changes to the Competitive Acquisition of Certain Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) by Certain Provisions of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA).''
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