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Briefs, oral arguments, agency decisions and the Federal Register.
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Removal of Regulations Regarding Certification of Drugs Composed Wholly or Partly of Insulin
Federal Register · Rule · May 13, 1998
The comment period for the direct final rule runs concurrently with that of the [[Page 26695]] companion proposed rule. … adverse comment.
63 FR 26694Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 14, 2021
the provisions of the FD&C Act. … (Comment 3) One comment suggested adding a control arm comprised of physicians who have not attended a medical conference during the same period and asking them about their perceptions of the same products
86 FR 37160Health and Human Services DepartmentFood and Drug AdministrationDirect and Secondary Direct Food Additives; Sodium Mono- and Dimethyl Naphthalene Sulfonates
Federal Register · Rule · Feb 12, 1998
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. … Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to the Director, Center for Food Safety and Applied Nutrition
63 FR 7068Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 3, 2004
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 … To ensure that comments on the information collection are received, OMB recommends that comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: Fumie Yokota, Desk Officer for
69 FR 31395Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 21, 2016
The 1984 amendments include what is now section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)(7)), which requires FDA to publish a list of all approved drugs. … The drug product labeling recommends extensive safety monitoring, including baseline blood studies followed by periodic blood studies approximately every 2 days during therapy.
81 FR 64914Health and Human Services DepartmentFood and Drug AdministrationAdvisory Committee; Notice of Meeting
Federal Register · Uncategorized Document · Jul 7, 1994
emphasized, however, that the 1 hour time limit for an open public hearing represents a minimum rather than a maximum time for public participation, and an open public hearing may last for whatever longer period … This notice is issued under section 10(a)(1) and (2) of the Federal Advisory Committee Act (5 U.S.C. app. 2), and FDA's regulations (21 CFR part 14) on advisory committees. Dated: June 30,1994.
Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Feb 2, 2012
Each comment is numbered to help distinguish among different comments. … (Comment 1)—One comment requested that FDA provide notice and an opportunity to comment should it propose to end this period of enforcement discretion as it applies to tobacco products.
77 FR 5171Health and Human Services DepartmentFood and Drug AdministrationFood Additives Permitted in Feed and Drinking Water of Animals; Natamycin
Federal Register · Rule · Apr 13, 2004
The notice of filing of FAP 2234 provided for a 60-day comment period. No comments have been received. … (e) To assure the safe use of the additive, the label or labeling of the additive shall bear, in addition to other information required by the Federal Food, Drug, and Cosmetic Act, the following: (1)
69 FR 19320Health and Human Services DepartmentFood and Drug AdministrationPostmarketing Studies for Human Drugs and Licensed Biological Products; Status Reports
Federal Register · Proposed Rule · Dec 1, 1999
DATES: Submit written comments on the proposed rule by February 14, 2000. Submit written comments on the information collection provisions by January 3, 2000. … act.
64 FR 67207Health and Human Services DepartmentFood and Drug AdministrationAdvisory Committee; Notice of Meeting
Federal Register · Notice · Jun 19, 1997
Elsewhere in this issue of the Federal Register, FDA is also extending the comment period on a proposed rule regarding labeling requirements for OTC drug products that appeared in the Federal Register … the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation.I11Notice of this meeting is given under the Federal Advisory Committee Act
62 FR 33427Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 10, 2020
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. … Enrolled jurisdictions must conduct the work described in tables 1, 2, and 3 over a 5-year period.
85 FR 41588Health and Human Services DepartmentFood and Drug AdministrationMedical Device Classification Procedures
Federal Register · Proposed Rule · Mar 25, 2014
Submit comments on information collection issues under the Paperwork Reduction Act of 1995 (the PRA) by April 24, 2014. ADDRESSES: You may submit comments, identified by Docket No. … Paperwork Reduction Act of 1995 VIII. Proposed Effective Date IX. Comments SUPPLEMENTARY INFORMATION: I.
79 FR 16252Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Nov 28, 1997
Background The 1984 amendments included a provision, codified under section 505(j)(4)(B)(iv) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355(j)(4)(B)(iv)), granting 180 days of … The regulations in Sec. 314.107(c) were issued through notice and comment rulemaking with the active participation of the pharmaceutical industry and consumer groups.
62 FR 63268Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Oct 4, 2016
This section requires FDA to publish in the Federal Register a notice of intent to exempt a device, or of the petition, and to provide a 30-day comment period. … FDA received no comments regarding this petition.
81 FR 68295Health and Human Services DepartmentFood and Drug AdministrationNew Method for the Analysis of Sulfites in Foods
Federal Register · Rule · Jan 18, 2022
Comments on the Proposed Rule and FDA Response There were two comments to the proposed rule. Both comments expressed general support for the rule. … As the comments did not raise any issues, we have not revised the rule in response to the comments.
87 FR 2542Health and Human Services DepartmentFood and Drug AdministrationFood Additives Permitted in Feed and Drinking Water of Animals; Formaldehyde
Federal Register · Rule · Oct 6, 1998
The notice of filing provided for a 30-day comment period on the petitioner's environmental assessment. No comments have been received. … The label also contains a statement that ``Formaldehyde is subject to SARA Title III, Section 313 reporting'' (Superfund Amendments and Reauthorization Act (SARA), and the Occupational Safety and Health
63 FR 53579Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 28, 2014
DATES: Fax written comments on the collection of information by June 27, 2014. … Enrolled jurisdictions must conduct the work described in tables 1, 2, and 3 over a 5-year period.
79 FR 30616Health and Human Services DepartmentFood and Drug AdministrationImport Tolerances for Residues of Unapproved New Animal Drugs in Food
Federal Register · Proposed Rule · Jan 25, 2012
Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by February 24, 2012, (see the “Paperwork Reduction Act of 1995” section of this document). … Comments received from the public on this issue were similar to the comments that were received from VMAC.
77 FR 3653Health and Human Services DepartmentFood and Drug AdministrationCertain Requirements Regarding Prescription Drug Marketing
Federal Register · Proposed Rule · Feb 4, 2022
DATES: Submit either electronic or written comments on the proposed rule by April 5, 2022. ADDRESSES: You may submit comments as follows. … relationship means an association that exists when a manufacturer and a distributor enter into a written agreement under which the distributor is authorized to distribute the manufacturer's drug samples for a period
87 FR 6443Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 30, 2025
As required by section 743(b)(2)(B)(iii) of the FD&C Act, FDA published guidelines in consideration of the burden of the VQIP fee on small businesses and provided for a period of public comment on the … Consistent with section 743(b)(2)(B)(iii) of the FD&C Act, if we determine to provide for a small business fee reduction, we will adjust the fee schedule for small businesses only through notice and comment
90 FR 35863Health and Human Services DepartmentFood and Drug Administration
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