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Federal Register · Rule · Aug 28, 2000
FDA received three significant adverse comments during the comment period, and the agency has considered these comments in developing the final rule. … Flexibility Act (5 U.S.C. 601-612 (as amended by subtitle D of the Small Business Regulatory Fairness Act of 1996 (Public Law 104-121)), and the Unfunded Mandates Reform Act of 1995 (Public Law 104-4)
65 FR 52016Health and Human Services DepartmentFood and Drug AdministrationProduct-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability
Federal Register · Notice · Feb 16, 2024
Under that process, draft guidances are posted on FDA's website and announced periodically in the Federal Register . … Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required. V.
89 FR 12354Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Mar 27, 2024
Therefore, designated countries may respond to our periodic requests by submitting information to confirm their designations remain appropriate. … Although three comments were received, the comments were not responsive to the four collection of information topics solicited.
89 FR 21257Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 2, 2006
period. … Paperwork Reduction Act of 1995 This draft revised guidance refers to previously approved collections of information found in FDA regulations.
71 FR 25846Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Feb 27, 2014
A withdrawal period has not been established for this product in preruminating calves. … A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal 016592 (2) Chickens.
79 FR 10976Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 29, 2008
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 … records of compensation agreements with any compensation paid to nonemployee clinical investigators, including information showing any financial interests held by the clinical investigator, for a time period
73 FR 79493Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 6, 2022
(FD&C Act) (21 U.S.C. 360j(g)), which governs exemption for devices for investigational use. … recordkeeping burden attributable to provisions in part 812 to reflect those requirements associated with clinical investigations conducted outside the United States, and in recognition of the required retention period
87 FR 27168Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 3, 2012
The Tobacco Control Act amended the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 301 et seq. ) by, among other things, adding a new chapter granting the FDA important new authority … FDA experience over the past 2 years in the regulation of tobacco products and is based on the actual number of establishment registration and product ingredient submissions received during this time period
77 FR 26281Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Apr 25, 2017
Administration (FDA or we) 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 … diagnostic testing of the donor indicating T. cruzi infection, we recommend that the establishment notify consignees of all previously distributed blood and blood components collected during the lookback period
82 FR 19062Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 19, 2003
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 … During that 4-year period, an average of five antimicrobial NADAs (including original and major supplements) was approved in food-producing animals per year.
68 FR 54906Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Feb 25, 2019
of the FD&C Act (21 U.S.C. 350d). … We annualize this estimate by dividing the total number of burden hours (70) over a 3-year period as reflected in table 2, row 1.
84 FR 6009Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 11, 2016
In the Federal Register of April 9, 2014 (79 FR 19622), the Agency announced that the deadline for the comment period would be extended until May 7, 2014, to allow for more public comments on this … Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information found in FDA regulations and guidance.
81 FR 70120Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Apr 20, 2016
The public comment period closed on June 25, 2003. A number of comments were received, which the Agency considered carefully as it prepared this revised draft guidance. … Paperwork Reduction Act of 1995 This draft guidance contains information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act
81 FR 23303Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 17, 2012
for public comment in response to the notice. … the provisions of the FD&C Act.
77 FR 2299Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 11, 2019
of the FD&C Act (21 U.S.C. 350d). … We annualize this estimate by dividing the total number of burden hours (70) over a 3-year period as reflected in table 2, row 1.
84 FR 27131Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Mar 10, 2005
Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520). … Any subsequent change to the device requiring the submission of a premarket notification in accordance with section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360) should be
70 FR 11990Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Apr 6, 2000
for public comment in response to the notice. … The contractor will develop and maintain an active data base to track adoptions of the Food Code; identify and periodically contact State, local, and tribal food safety program administrators to determine
65 FR 18110Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Jul 23, 2026
The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes us to regulate “color additives” (see section 721(b) of the FD&C Act (21 U.S.C. 379e(b))). … FD&C Act).
91 FR 46276Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Nov 30, 2017
FDA is publishing this document to obtain comments regarding this proposed exemption, in accordance with the Federal Food, Drug, and Cosmetic Act (FD&C Act). … To do so, FDA must publish in the Federal Register notice of its intent to exempt the device, or of the petition, and provide a 60-calendar day period for public comment.
82 FR 56763Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 15, 2007
FDA requests comments on this estimate. … Under the statute, the records must be retained for a period of 6 years.
72 FR 58313Health and Human Services DepartmentFood and Drug Administration
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