Department of Health and Human Services October 2007 – Federal Register Recent Federal Regulation Documents
Results 301 - 338 of 338
Guidance for Industry: Recommended Study Design and Evaluation of Effectiveness Studies for Swine Respiratory Disease Claims; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry (178) entitled ``Recommended Study Design and Evaluation of Effectiveness Studies for Swine Respiratory Disease Claims.'' This guidance provides recommendations to industry relating to study design and describes the criteria that the Center for Veterinary Medicine (CVM) intends to use to evaluate effectiveness studies for swine respiratory disease (SRD) claims.
Agency Emergency Processing Under OMB Review; Medical Device User Fee Amendments of 2007; Foreign Small Business Qualification Certification Form FDA 3602A
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 emergency processing under the Paperwork Reduction Act of 1995 (the PRA). The proposed collection of information concerns a new FDA foreign small business qualification certification form that will allow a foreign business to qualify as a ``small business'' and pay certain medical device user fees at reduced rates.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Submission of Petitions: Food Additive, Color Additive (Including Labeling), and Generally Recognized as Safe Affirmation; Electronic Submission Using Food and Drug Administration Forms 3503 and 3504
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Submission of Petitions: Food Additive, Color Additive (Including Labeling), and Generally Recognized as Safe Affirmation; Electronic Submission Using Food and Drug Administration Forms 3503 and 3504'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Drug Products Containing Hydrocodone; Enforcement Action Dates
The Food and Drug Administration (FDA) is announcing its intention to take enforcement action, as described in this notice, against unapproved drug products containing hydrocodone bitartrate, or any other salt or ester of hydrocodone (hereinafter collectively ``hydrocodone''), and persons who manufacture or cause the manufacture of such products or their shipment in interstate commerce. Unapproved hydrocodone products have been implicated in reports of medication errors, including improper dosing and dispensing the wrong drug. Some of these products omit important labeling warnings and information or are inappropriately labeled for use in young children. Drug products containing hydrocodone are new drugs that require approved applications because they are not generally recognized as safe and effective. Manufacturers who wish to market a drug product containing hydrocodone must obtain FDA approval of a new drug application (NDA) or an abbreviated new drug application (ANDA).
Joint Meeting of the Nonprescription Drugs Advisory Committee and the Pediatric Advisory Committee; Amendment of Notice
The Food and Drug Administration (FDA) is announcing an amendment to the notice of a joint meeting of the Nonprescription Drugs Advisory Committee and the Pediatric Advisory Committee. This meeting was announced in the Federal Register of August 16, 2007 (72 FR 46091). The amendment is being made to reflect a change in the Procedure portion of the document. There are no other changes.
Foreign Quarantine Regulations, Proposed Revision of HHS/CDC Animal-Importation Regulations
On July 31, 2007, CDC published an advanced notice of proposed rulemaking (ANPRM), ``Foreign Quarantine regulations, Proposed Revision of HHS/CDC Animal-Importation Regulations,'' (72 FR 41676) to begin the process of revising HHS/CDC Animal Importation Regulations that cover dogs and cats (42 CFR 71.51), and to consider extending these regulations to cover domesticated ferrets. The ANPRM will also address the importation of African rodents (42 CFR 71.56) into the United States. HHS/CDC is also considering the need for additional regulations to prevent the introduction of zoonotic diseases into the United States. CDC provided a 60-day pubic comment period, with written comments to be received on or before October 1, 2007. CC has received requests asking for an extension of the comment period. In consideration of these requests, CDC is extending the comment period an additional 60 days, with a new closing date of December 1, 2007.
Medicare Program; Hospice Wage Index for Fiscal Year 2008 Correction
This document corrects typographical errors that appeared in the final rule published in the August 31, 2007 Federal Register entitled ``Medicare Program; Hospice Wage Index for Fiscal Year 2008.''
Medicare Program; Criteria and Standards for Evaluating Intermediary and Carrier Performance During Fiscal Year 2008
This general notice with comment period describes the criteria and standards to be used for evaluating the performance of fiscal intermediaries (FI) and carriers in the administration of the Medicare program. The results of these evaluations are considered whenever we enter into, renew, or terminate a FI agreement, carrier contract, or take other contract actions, for example, assigning or reassigning providers or services to a FI or designating regional or national intermediaries. We are requesting public comment on these criteria and standards.
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