Department of Health and Human Services March 2005 – Federal Register Recent Federal Regulation Documents

Guidance for Review Staff and Industry on Good Review Management Principles and Practices for Prescription Drug User Fee Act Products; Availability
Document Number: 05-6404
Type: Notice
Date: 2005-03-31
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a guidance for review staff and industry entitled ``Good Review Management Principles and Practices for PDUFA Products.'' This is one in a series of guidance documents that FDA agreed to draft and implement in conjunction with the June 2002 reauthorization of the Prescription Drug User Fee Act of 1992 (PDUFA).
Agency Information Collection Activities: Proposed Collection: Comment Request
Document Number: 05-6354
Type: Notice
Date: 2005-03-31
Agency: Department of Health and Human Services, Health Resources and Services Administration
Antimalarial Drug Resistance and Prevention of Malaria During Pregnancy; Notice of Intent To Fund Single Eligibility Award
Document Number: 05-6344
Type: Notice
Date: 2005-03-31
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Science Board to the Food and Drug Administration; Notice of Meeting
Document Number: 05-6333
Type: Notice
Date: 2005-03-31
Agency: Food and Drug Administration, Department of Health and Human Services
Summaries of Medical and Clinical Pharmacology Reviews of Pediatric Studies; Availability
Document Number: 05-6332
Type: Notice
Date: 2005-03-31
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of summaries of medical and clinical pharmacology reviews of pediatric studies submitted in supplements for AGRYLIN (anagrelide), CLOLAR (clofarabine), and DIFLUCAN (fluconazole). These summaries are being made available consistent with the Best Pharmaceuticals for Children Act (BPCA). For all pediatric supplements submitted under the BPCA, the BPCA requires FDA to make available to the public a summary of the medical and clinical pharmacology reviews of the pediatric studies conducted for the supplement.
Cardiovascular and Renal Drugs Advisory Committee; Cancellation
Document Number: 05-6331
Type: Notice
Date: 2005-03-31
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is canceling the meeting of the Cardiovascular and Renal Drugs Advisory Committee scheduled for April 5, 2005. This meeting was announced in the Federal Register of March 9, 2005 (70 FR 11678).
Announcement of Availability of Funds for Adolescent Family Life (AFL) Demonstration Projects
Document Number: 05-6272
Type: Notice
Date: 2005-03-30
Agency: Department of Health and Human Services
The Office of Adolescent Pregnancy Programs (OAPP) of the Office of Population Affairs (OPA) published a notice in the Federal Register of February 2, 2005, Doc. 70-5536, Part III, announcing the availability of funds for Adolescent Family Life (AFL) Demonstration Projects. Since that time, the Office of Public Health and Science (OPHS) has begun to participate with the government-wide grants initiative referred to as ``Grants.gov Find and Apply.''
Development of Influenza Surveillance Network in Vietnam; Notice of Intent To Fund Single Eligibility Award
Document Number: 05-6244
Type: Notice
Date: 2005-03-30
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
National Institute of Child Health and Human Development; Notice of Closed Meeting
Document Number: 05-6222
Type: Notice
Date: 2005-03-30
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 05-6221
Type: Notice
Date: 2005-03-30
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 05-6219
Type: Notice
Date: 2005-03-30
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Arthritis and Musculoskeletal and Skin Diseases; Notice of Closed Meeting
Document Number: 05-6218
Type: Notice
Date: 2005-03-30
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings.
Document Number: 05-6217
Type: Notice
Date: 2005-03-30
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Complementary and Alternative Medicine; Notice of Closed Meeting
Document Number: 05-6216
Type: Notice
Date: 2005-03-30
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Child Health and Human Development; Notice of Closed Meeting
Document Number: 05-6215
Type: Notice
Date: 2005-03-30
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Amended Notice of Meeting
Document Number: 05-6214
Type: Notice
Date: 2005-03-30
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Amended Notice of Meeting
Document Number: 05-6213
Type: Notice
Date: 2005-03-30
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Child Health and Human Development; Notice of Closed Meeting
Document Number: 05-6212
Type: Notice
Date: 2005-03-30
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Child Health and Human Development; Notice of Closed Meeting
Document Number: 05-6211
Type: Notice
Date: 2005-03-30
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: 05-6210
Type: Notice
Date: 2005-03-30
Agency: Department of Health and Human Services, National Institutes of Health
Statement of Organization, Functions and Delegations of Authority
Document Number: 05-6205
Type: Notice
Date: 2005-03-30
Agency: Department of Health and Human Services, Health Resources and Services Administration
Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Study of Qualified Health Claims: Consumer Inferences About Omega-3 Fatty Acids and Monounsaturated Fatty Acids From Olive Oil
Document Number: 05-6203
Type: Notice
Date: 2005-03-30
Agency: Food and Drug Administration, Department of Health and Human Services
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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on a voluntary experimental study of consumer inferences about qualified health claims for omega-3 fatty acids and monounsaturated fatty acids from olive oil.
Guidances for Industry on Premarketing Risk Assessment; Development and Use of Risk Minimization Action Plans; and Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment; Availability
Document Number: 05-6200
Type: Notice
Date: 2005-03-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of three guidances for industry entitled ``Premarketing Risk Assessment,'' ``Development and Use of Risk Minimization Action Plans,'' and ``Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment.'' These guidances provide guidance to industry on risk management activities for drug products, including biological drug products, in the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). The guidances address, respectively, premarket risk assessment; the development, implementation, and evaluation of risk minimization action plans for drug products; and good pharmacovigilance practices and pharmacoepidemiologic assessment of observational data.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 05-6172
Type: Notice
Date: 2005-03-29
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
This notice announces the intention of the agency for Healthcare Research and Quality (AHRQ) to request the Office of Management and Budget (OMB) to allow the proposed information collection project: ``National Study of the Hospital Adverse Event Reporting Survey''. In accordance with the Paperwork Reduction Act of 1995, 44 U.S.C. 3506(c)(2)(A), AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously published in the Federal Register on January 24, 2005, and allowed 60 days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment.
Meeting of the National Advisory Council for Healthcare Research and Quality
Document Number: 05-6171
Type: Notice
Date: 2005-03-29
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
In accordance with section 10(a) of the Federal Advisory Committee Act, this notice announces a meeting of the National Advisory Council for Healthcare Research and Quality.
Proposed Information Collection Activity; Comment Request
Document Number: 05-6170
Type: Notice
Date: 2005-03-29
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
Referral of KEMSTRO (Baclofen) and DROXIA (Hydroxyurea) for the Conduct of Pediatric Studies
Document Number: 05-6158
Type: Notice
Date: 2005-03-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the referral of KEMSTRO (baclofen) and DROXIA (hydroxyurea) to the Foundation for the National Institutes of Health (the Foundation) for the conduct of pediatric studies. FDA referred KEMSTRO (baclofen) and DROXIA (hydroxyurea) to the Foundation on September 1, 2004, and October 20, 2004, respectively. FDA is publishing this notice of the referrals in accordance with the Best Pharmaceuticals for Children Act (BCPA).
Tolerances for Residues of New Animal Drugs in Food; Zeranol
Document Number: 05-6156
Type: Rule
Date: 2005-03-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Schering-Plough Animal Health Corp. The supplemental NADA provides for the establishment of a tolerance for residues of zeranol in edible tissues of sheep. Accordingly, the analytical method for detecting residues of zeranol in uncooked edible tissues of sheep is being removed from the animal drug regulations.
Color Additive Certification; Increase in Fees for Certification Services
Document Number: 05-6155
Type: Rule
Date: 2005-03-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is issuing an interim final rule to amend the color additive regulations by increasing the fees for certification services. The change in fees will allow FDA to continue to maintain an adequate color certification program as required by the Federal Food, Drug, and Cosmetic Act (the act). The fees are intended to recover the full costs of operation of FDA's color certification program.
Agency Information Collection Activities; Proposed Collection; Comment Request; Certification of Maintenance of Effort Form Title III of the Older Americans Act, Grants for State and Community Programs on Aging
Document Number: 05-6095
Type: Notice
Date: 2005-03-29
Agency: Aging Administration, Department of Health and Human Services
The Administration on Aging (AoA) 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 requirements relating to Certification of Maintenance of Effort Form Title III of the Older Americans Act, Grants for State and Community Programs on Aging.
Agency Information Collection Activities; Proposed Collection; Comment Request; State Annual Long-Term Care Ombudsman Report and Instructions for Older Americans Act Title VII
Document Number: 05-6094
Type: Notice
Date: 2005-03-29
Agency: Aging Administration, Department of Health and Human Services
The Administration on Aging (AoA) 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 requirements relating to State Annual Long-Term Care Ombudsman Report and instructions for Older Americans Act Title VII.
Food Additives Permitted for Direct Addition to Food for Human Consumption; Glycerol Ester of Gum Rosin
Document Number: 05-6089
Type: Rule
Date: 2005-03-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is amending the food additive regulations to provide for the safe use of glycerol ester of gum rosin (GEGR) to adjust the density of citrus oils used in the preparation of beverages. This action is in response to a petition filed by T&R Chemicals, Inc.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Format and Content for Over-the-Counter Drug Product Labeling
Document Number: 05-6088
Type: Notice
Date: 2005-03-29
Agency: Food and Drug Administration, Department of Health and Human Services
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 (the PRA).
Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting
Document Number: 05-6087
Type: Notice
Date: 2005-03-29
Agency: Food and Drug Administration, Department of Health and Human Services
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Irradiation in the Production, Processing, and Handling of Food
Document Number: 05-6086
Type: Notice
Date: 2005-03-29
Agency: Food and Drug Administration, Department of Health and Human Services
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.
Draft Guidance for Industry on Systemic Lupus Erythematosus-Developing Drugs for Treatment; Availability
Document Number: 05-6085
Type: Notice
Date: 2005-03-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Systemic Lupus ErythematosusDeveloping Drugs for Treatment.'' The draft guidance is intended to provide recommendations for industry on developing drugs for the treatment of systemic lupus erythematosus (SLE). Specific topics include measurement of lupus disease activity and clinical outcomes, reduction in disease activity and flares, treatment of organ- specific disease, trial design issues and analysis, surrogate markers as endpoints, and risk-benefit assessment.
Meeting of the Citizens' Health Care Working Group
Document Number: 05-6176
Type: Notice
Date: 2005-03-28
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
In accordance with section 10(a) of the Federal Advisory Committee Act, this notice announces the first meeting of the Citizens' Health Care Working Group mandated by section 1014 of the Medicare Modernization Act.
Privacy Act of 1974, as Amended; Computer Matching Program
Document Number: 05-6056
Type: Notice
Date: 2005-03-28
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
In compliance with the Privacy Act of 1974, as amended by Pub. L. 100-503, the Computer Matching and Privacy Protection Act of 1988, we are publishing a notice of a computer matching program that OCSE will conduct on behalf of itself and the District of Columbia Department of Human Services, Income Maintenance Administration (IMA) for verification of continued eligibility for Public Assistance. The match will utilize National Directory of New Hire (NDNH) records and IMA records. The purpose of the computer matching program is to exchange personal data for purposes of identifying individuals who are employed and also are receiving payments pursuant to the Temporary Assistance for Needy Families (TANF) benefit program administered by IMA.
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: 05-6032
Type: Notice
Date: 2005-03-28
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: 05-6031
Type: Notice
Date: 2005-03-28
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Irradiation in the Production, Processing, and Handling of Food; Correction
Document Number: 05-6024
Type: Rule
Date: 2005-03-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is correcting a final rule that appeared in the Federal Register of December 23, 2004 (69 FR 76844). The document amended the food additive regulations by establishing a new maximum permitted energy level of x rays for treating food of 7.5 million electron volts provided the x rays are generated from machine sources that use tantalum or gold as the target material, with no change in the maximum permitted dose levels or uses currently permitted by FDA's food additive regulations. The document was published with two errors in the preamble section. This document corrects those errors.
Meeting of the Secretary's Advisory Committee on Human Research Protections
Document Number: 05-6021
Type: Notice
Date: 2005-03-28
Agency: Department of Health and Human Services
Pursuant to Section 10(a) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given that the Secretary's Advisory Committee on Human Research Protections (SACHRP) will hold its seventh meeting. The meeting will be open to the public.
Food and Drug Administration/Drug Information Association Cross Labeling; Public Meeting; Combination Products and Mutually Conforming Labeling
Document Number: 05-5978
Type: Notice
Date: 2005-03-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA), in cooperation with the Drug Information Association (DIA), is announcing a public meeting to solicit views and provide an interactive forum for discussion of stakeholders' perspectives about, and experiences with, the legal and public health issues that arise when sponsors seek to develop or market a product of one type (device, drug, or biological product) that would be labeled for use with an already approved product of a different type, and the approved product's labeling would not be changed. The input received at the meeting and comments made to the docket after the meeting will be considered in developing draft guidance on this topic.
Draft Guidance for Industry on Using a Centralized Institutional Review Boards Process in Multicenter Clinical Trials; Availability
Document Number: 05-5977
Type: Notice
Date: 2005-03-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Using a Centralized IRB Process in Multicenter Clinical Trials.'' The draft guidance is intended to assist sponsors, institutions, institutional review boards (IRBs), and clinical investigators involved in multicenter clinical research in meeting the requirements of FDA's regulations by facilitating the use of a centralized IRB review process.
Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals
Document Number: 05-5976
Type: Notice
Date: 2005-03-28
Agency: Food and Drug Administration, Department of Health and Human Services
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 current good manufacturing practice (CGMP) regulations for finished pharmaceuticals.
Determination That ACIPHEX (Rabeprazole Sodium) Delayed-Release Tablets, 10 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Document Number: 05-5975
Type: Notice
Date: 2005-03-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) has determined that ACIPHEX (rabeprazole sodium) delayed-release tablets, 10 milligrams (mg), were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for rabeprazole sodium delayed-release tablets, 10 mg.
Summaries of Medical and Clinical Pharmacology Reviews of Pediatric Studies; Availability
Document Number: 05-5974
Type: Notice
Date: 2005-03-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of summaries of medical and clinical pharmacology reviews of pediatric studies submitted in supplements for PARAPLATIN (carboplatin), TRUSOPT (dorzolamide), CAMPTOSAR (irinotecan), PREVACID (lansoprazole), TAMIFLU (oseltamivir), VIOXX (rofecoxib), FERRLECIT (sodium ferric gluconate), IMITREX (sumatriptan), DETROL and DETROL LA (tolterodine). These summaries are being made available consistent with the Best Pharmaceuticals for Children Act (the BPCA). For all pediatric supplements submitted under the BPCA, the BPCA requires FDA to make available to the public a summary of the medical and clinical pharmacology reviews of the pediatric studies conducted for the supplement. In addition, the agency is also announcing the availability of summaries of medical and clinical pharmacology reviews of pediatric studies for the following antidepressants: CELAXA (citalopram), REMERON (mirtazapine), SERZONE (nefazodone), PAXIL (paroxetine), and ZOLOFT (sertraline). Studies for these drugs were submitted before the BPCA was implemented. Therefore, they are not subject to its requirements. However, due to the public's interest in these pediatric studies, FDA asked the sponsors to consent to the public disclosure of a summary of the medical and clinical pharmacology reviews for these studies. Based on sponsors' consent, FDA is making the summaries publicly available.