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Briefs, oral arguments, agency decisions and the Federal Register.
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Federal Register · Notice · Jul 26, 2022
We will need to screen approximately 54,000 potential participants (27,000 youth and 27,000 young adults) over the study period. … The survey will be repeated with a new cross-sectional sample approximately every month or every other month over a period of 18 months.
87 FR 44405Health and Human Services DepartmentFood and Drug AdministrationForeign Supplier Verification Programs for Importers of Food for Humans and Animals
Federal Register · Rule · Nov 27, 2015
(Comment 335) Some comments assert that there should be an informed compliance or transition period after the end of the pre-compliance period during which importers would be expected to comply gradually … Some comments specify 12 months as the appropriate time for such an informed compliance or transition period. Some comments ask that we give developing countries longer transition periods.
80 FR 74226Health and Human Services DepartmentFood and Drug AdministrationState Certification of Mammography Facilities
Federal Register · Rule · Feb 6, 2002
The proposed rule’s 90-day comment period ended on June 28, 2000. FDA analyzed the comments received and responds to them in sections III, V, and VI of this document. … A few of the comments dealt with paperwork issues and will be discussed in section VIII of this document (Paperwork Reduction Act of 1995).
67 FR 5446Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 26, 2000
ACTION: Request for written comments; reopening of comment period. … Dotzel, Acting Associate Commissioner for Policy.
65 FR 4252Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 29, 2025
The statutory authority to collect this information is provided under sections 351 and 361 of the Public Health Service Act (PHS Act) (42 U.S.C. 262 and 264) and the provisions of the Federal Food, Drug … , and Cosmetic Act (FD&C Act) that apply to drugs (21 U.S.C. 321 et seq. ).
90 FR 35689Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Oct 15, 2004
FDA would like comments regarding labeling, such as the following: • How often to apply the product, • The effect of bathing or showering before the duration of effect period ends, and • Whether any … Comment No. PRC1. 2. Comment No. PRC2. 3. Comment No. SUP4. 4. Comment No. C54. X.
69 FR 61148Health and Human Services DepartmentFood and Drug AdministrationUniform Compliance Date for Food Labeling Regulations
Federal Register · Rule · Dec 31, 2002
FDA periodically announces uniform compliance dates for new food labeling requirements to minimize the economic impact of label changes. … SUPPLEMENTARY INFORMATION: FDA periodically issues regulations requiring changes in the labeling of food.
67 FR 79851Health and Human Services DepartmentFood and Drug AdministrationPrescription Drug User Fee Act; Public Meeting
Federal Register · Notice · Mar 16, 2010
public input on the reauthorization, hold a public meeting at which the public may present its views on the reauthorization, provide a period of 30 days after the public meeting to obtain written comments … This notice, the public meeting, the 30 day comment period after the meeting, and the posting of the comments on the FDA Web site will satisfy these requirements.
75 FR 12555Health and Human Services DepartmentFood and Drug AdministrationUniform Compliance Date for Food Labeling Regulations
Federal Register · Rule · Dec 20, 2018
SUPPLEMENTARY INFORMATION: We periodically issue regulations requiring changes in the labeling of food. … Act of 1995 (Pub.
83 FR 65294Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 15, 2003
Ca-DTPA and Zn-DTPA Diethylenetriaminepentaacetate (DTPA) is a ligand that acts as a chelator with a very high affinity for plutonium, americium, and curium. … However, we welcome comments on the guidance, and if comments are submitted, we will review them and revise the guidance if appropriate.
68 FR 53984Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 27, 1999
In the Federal Register of October 6, 1998 (63 FR 53675), the agency requested comments on the proposed collection of information. No comments were received. … Section 814.84 specifies the contents of periodic reports. [[Page 4113]] II.
64 FR 4112Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Apr 2, 2018
The arguments challenge the regulatory requirements of the Administrative Procedure Act (APA) and FD&C Act with regard to notice and comment rulemaking. … Arguments Regarding the Administrative Procedure Act a. Notice and comment rulemaking.
83 FR 13994Health and Human Services DepartmentFood and Drug AdministrationStatus of Certain Additional Over-the-Counter Drug Category II Active Ingredients
Federal Register · Proposed Rule · Jun 19, 2008
FDA requests comment on this issue. … FDA requests comment on this issue. VI. Paperwork Reduction Act of 1995 This proposed rule contains no collections of information.
73 FR 34895Health and Human Services DepartmentFood and Drug AdministrationUniform Compliance Date for Food Labeling Regulations
Federal Register · Rule · Jan 3, 2023
Background We periodically issue regulations requiring changes in the labeling of food. … Reform Act of 1995 (Pub.
88 FR 6Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Apr 22, 2016
/or section 351 of the PHS Act (42 U.S.C. 262). … Elsewhere in this issue of the Federal Register , FDA is announcing the extension of the comment period for the four draft guidance documents.
81 FR 23661Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 10, 2004
This notice solicits comments on information collection requirements for medical devices; third-party review under the Food and Drug Modernization Act of 1997 (FDAMA). … Third-party reviews should maintain records of their 510(k) reviews and a copy of the 510(k) for a reasonable period of time, usually a period of 3 years.
69 FR 48508Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 19, 2010
ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk … Medical Device User Fee Cover Sheet—Form FDA 3601—OMB Control Number 0910-0511—Extension The Federal Food, Drug, and Cosmetic Act, as amended by the Medical Device User Fee and Modernization Act of
75 FR 2866Health and Human Services DepartmentFood and Drug AdministrationNew Animal Drugs; Phenylbutazone; Extralabel Animal Drug Use; Order of Prohibition
Federal Register · Rule · Feb 28, 2003
Section 530.25 provides for a public comment period of not less than 60 days. … The order will become effective May 29, 2003, unless we revoke or modify the order, or extend the comment period.
68 FR 9528Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 6, 2010
FDA will issue a final guidance within one year of the close of the public comment period.” … The draft guidance was dated September 30, 2008 (73 FR 58604, October 7, 2008); the comment period closed on January 5, 2009.
75 FR 875Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 3, 2015
period illnesses, injuries, or deaths can result. … followup and investigation period, and an immediate decision on a recall.
80 FR 45999Health and Human Services DepartmentFood and Drug Administration
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