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Medical Devices; Radiology Devices; Reclassification of Full-Field Digital Mammography System
Federal Register · Rule · Nov 5, 2010
Comments and FDA's Response During the public comment period, 23 respondents submitted comments. … (Response) FDA agrees with the comment and has revised the identification to be similar to the language suggested by the comment. V.
75 FR 68200Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 9, 2014
Paperwork Reduction Act of 1995 Under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each … Comments The draft guidance is being distributed for comment purposes only and is not intended for implementation at this time.
79 FR 73081Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 12, 1999
The comments in the docket will be periodically reviewed, and, where appropriate, the guidances will be amended. … Dotzel, Acting Associate Commissioner for Policy. [FR Doc. 99-26501 Filed 10-8-99; 8:45 am] BILLING CODE 4160-01-F
64 FR 55293Health and Human Services DepartmentFood and Drug AdministrationIndirect Food Additives: Paper and Paperboard Components
Federal Register · Rule · Mar 7, 1997
No comments were received during the 30 day comment period specified in the filing notice for comments on the environmental assessment submitted with the petition. … The authority citation for 21 CFR part 176 continues to read as follows: Authority: Secs. 201, 402, 406, 409, 721 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 342, 346, 348, 379e).
62 FR 10452Health and Human Services DepartmentFood and Drug AdministrationFood Labeling: Health Claims; D-tagatose and Dental Caries
Federal Register · Rule · Jul 3, 2003
Comments from seven consumers were sent to this docket during the comment period, none of which were relevant to this rulemaking. … No comments from State or local government entities were received.
68 FR 39831Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 31, 2016
For such donors, the guidance recommends a deferral period of 120 days after a positive viral test or the resolution of symptoms, whichever timeframe is longer. … Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information found in FDA regulations.
81 FR 60005Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Nov 3, 2016
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 … deactivate the Plan and make decisions during the emergency, (2) prioritizing the manufacturer's drug products based on medical necessity, (3) identifying actions that should be taken prior to an anticipated period
81 FR 76618Health and Human Services DepartmentFood and Drug AdministrationEvaporated Milk; Amendment of the Standard of Identity
Federal Register · Uncategorized Document · Apr 14, 1994
These data show that the yearly average milkfat content for all producers' milk, before standardization for beverage purposes, during the period 1970 to 1991 (Ref. 1) ranged between 3.64 percent and 3.68 … The Regulatory Flexibility Act requires that the agency analyze options for regulatory relief for small businesses.
Food and Drug AdministrationFood Labeling: Health Claims; Omega-3 Fatty Acids and the Risk in Adults of Cardiovascular Disease
Federal Register · Rule · Jun 22, 1998
comment and publication of a final regulation'' if the agency ``determines that such action is necessary * * * to enable [FDA] to act promptly to ban or modify a claim'' under section 403(r) of the act … FDA invites public comment on this interim final rule. The agency will consider modifications to this interim final rule based on comments made during the comment period.
63 FR 34107Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 20, 2019
In the 1990s, longer acting forms of amphetamine were introduced to the market. … During this same period, a steep increase in the diagnosis of ADHD in the United States led to a parallel increase in societal exposure to prescribed amphetamine and related stimulant products.
84 FR 49530Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · May 3, 2016
basis for sampling, consistent with table 18 in the final rule “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption” (80 FR 74354 at 74475) and discussion under Comment … The definitions and interpretations of terms in section 201 of the Federal Food, Drug, and Cosmetic Act apply to such terms when used in this part.
81 FR 26466Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Mar 14, 2007
the provisions of the act. … If this were not possible, they requested that the comment period remain open until commenters have the ability to look at the questionnaire materials.
72 FR 11889Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 15, 2016
Second, this guidance discusses methods of detecting DILI by periodic tests of serum enzyme activities and of bilirubin concentration and how changes in the results of these laboratory tests over time, … FDA published a draft of this guidance in 2006, and comments on that draft were taken into consideration when issuing the final guidance in July 2009. II.
81 FR 2222Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Oct 7, 2016
Another suggested that additions and changes to the withdrawn or removed list be made through notice and comment rulemaking, observing that such a notice and comment period will allow stakeholders to review … (Comment 14) One comment observed that under both sections 503A and 503B of the FD&C Act, drugs may be added to the list if they have been found to be not effective.
81 FR 69668Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Apr 18, 2017
Background On July 12, 2012, FDA approved a risk evaluation and mitigation strategy (REMS) for extended release (ER) and long-acting (LA) opioid analgesic medications (ER/LA Opioid Analgesics REMS). … Requests for Oral Comments: During online registration you may indicate if you wish to provide a statement during the Open Public Comment Period.
82 FR 18300Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Mar 29, 2023
ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. … ) 1 1 1 30 30 Subpart E—Postapproval Requirements: Postapproval requirements (814.82(a)(9)) 121 1 121 135 16,335 Periodic reports (814.84(b)) 764 1 764 10
88 FR 18552Health and Human Services DepartmentFood and Drug AdministrationDraft Voluntary National Retail Food Regulatory Program Standards; Availability
Federal Register · Notice · Nov 14, 2006
In addition, FDA's mission under section 903(b)(2)(A) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 393(b)(2)(A)) includes ensuring that foods are safe, wholesome, and sanitary, and … The overall program improvement cycle is a 3-year period for completion of all three management tasks. CHART 1.
71 FR 66336Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 17, 2015
Submit comments on the information collection issues under the Paperwork Reduction Act of 1995 by February 16, 2016. … Paperwork Reduction Act of 1995 Under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each
80 FR 78743Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Dec 4, 2013
Follow the instructions for submitting comments. … FDA cannot guarantee that all drugs nominated during the nomination period will be considered for inclusion on the next published bulk drugs list.
78 FR 72838Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 17, 2012
The basis for the proposal is that the sponsors have repeatedly failed to file required periodic reports for these applications. … Any other interested person may also submit comments on this notice.
77 FR 74672Health and Human Services DepartmentFood and Drug Administration
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