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Federal Register · Notice · Jan 5, 2001
Under section 502(a) of the act (21 U.S.C. 352(a)), a drug product is misbranded if its labeling is false or misleading in any particular, and under section 201(n) of the act (21 U.S.C. 321(n)), a drug … In the Federal Register of October 6, 2000 (65 FR 59849), FDA invited comments on the proposed information collection. No significant comments were received.
66 FR 1143Health and Human Services DepartmentFood and Drug AdministrationUse of Materials Derived From Cattle in Human Food and Cosmetics
Federal Register · Rule · Mar 18, 2016
period. … (Comment 26) Comments from the Biological Hazards Unit of EFSA in response to FDA's 2013 notice reopening the comment period clarified EFSA's current thinking on BSE infectivity in bovine intestines.
81 FR 14718Health and Human Services DepartmentFood and Drug AdministrationFood Labeling; Serving Sizes; Reference Amounts for Candies
Federal Register · Proposed Rule · Jan 8, 1998
Lengthen the Compliance Period FDA also considered the option of providing small entities with a longer compliance period. … A 2-year compliance period would reduce costs to $300 per firm. IX.
63 FR 1078Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 1, 1999
In response to a request from several of the Pearson plaintiffs, the agency has agreed to extend or reopen the comment period on the September 8, 1999, notice for 75 days after the agency issues its guidance … The agency will give careful consideration to any additional data it receives during the second 75-day comment period. IV.
64 FR 67289Health and Human Services DepartmentFood and Drug AdministrationDiacetyl Tartaric Acid Esters of Mono- and Diglycerides; Revision of Common or Usual Name
Federal Register · Uncategorized Document · Dec 1, 1994
DATES: Written comments by January 30, 1995. … In that rulemaking, FDA found, after a period of joint declaration of approximately the same length as the period during which DATEM and diacetyl tartaric acid esters of mono- and diglycerides have been
Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Nov 17, 2022
Given that FDA must comply with a court order and that the public can comment both by submitting comments to the docket and by participating in the public meeting, FDA believes that a 60-day comment period … is appropriate and does not intend to grant requests for extension of the comment period.
87 FR 69030Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 19, 2006
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 … Form FDA 2301 is used to submit the required transmittal of periodic reports and promotional material for new animal drugs.
71 FR 29157Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 14, 2016
Interested persons were invited to comment by February 29, 2016. In the Federal Register of January 27, 2016 (81 FR 4632), FDA extended the comment period to March 29, 2016. … FDA received and considered 21 sets of public comments and revised the guidance as appropriate. CDRH also intends to provide periodic public updates on the implementation of this guidance. II.
81 FR 90365Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 20, 2018
The DSCSA phases in its requirements over a 10-year period. A critical set of phased product tracing requirements outlined in section 582 of the FD&C Act relates to the product identifier. … The comment period for the draft guidance ended January 26, 2018. FDA received approximately 10 comments on the draft guidance.
83 FR 47622Health and Human Services DepartmentFood and Drug AdministrationAgency Information Collection Activities: Proposed Collection; Comment Request
Federal Register · Notice · Dec 11, 1997
(the act), designed to assure the adequate labeling of prescription (Rx) drugs. … Under section 502(a) of the act (21 U.S.C. 352(a)), a drug product is misbranded if its labeling is false or misleading in any particular, and under section 201(n) of the act (21 U.S.C. 321(n)), a drug's
62 FR 65273Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 28, 2020
FDA-2020-N-2252 for “Interim Assessment of the Program for Enhanced Review Transparency and Communication in the Biosimilar User Fee Act (BsUFA); Public Meeting; Request for Comments.” … Background The BsUFA was originally enacted in 2012 as the Biosimilar User Fee Act under the Food and Drug Administration Safety and Innovation Act (Pub. L. 112-144) for a period of 5 years.
85 FR 84345Health and Human Services DepartmentFood and Drug AdministrationTimothy Baxter; Final Order Announcing Termination Date of Debarment
Federal Register · Notice · Feb 29, 2024
ADDRESSES: Submit comments electronically at https://www.regulations.gov. … Timothy Baxter pursuant to section 306(b)(2)(B)(i)(I) of the FD&C Act (21 U.S.C. 335a(b)(2)(B)(i)(I)) for a period of 5 years from providing services in any capacity to a person with an approved or pending
89 FR 14861Health and Human Services DepartmentFood and Drug AdministrationFood Labeling: Ingredient Labeling of Dietary Supplements That Contain Botanicals
Federal Register · Rule · Aug 28, 2003
If FDA receives no significant adverse comments within the specified comment period, the agency intends to publish a document in the Federal Register confirming the effective date of this direct final … This comment period runs concurrently with that for the companion proposed rule.
68 FR 51693Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 31, 2006
DATES: Fax written comments on the collection of information by November 30, 2006. … 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 Officer
71 FR 63768Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Feb 19, 2026
Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed … The regulations were issued under FDA's statutory authority to regulate food safety, including section 402(a)(1) and (4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 342(a)(1) and (4)).
91 FR 8010Health and Human Services DepartmentFood and Drug AdministrationMedical Devices; Exemptions From Premarket Notification: Class II Devices; Request for Comments
Federal Register · Notice · Feb 6, 2026
FDA will review any comments submitted within the 60-day comment period and will consider whether the list of class II devices should be modified prior to publication of its final determination in the … Additionally, FDA must provide at least a 60-day comment period for any such notice published under section 510(m)(1)(A) of the FD&C Act.
91 FR 5485Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 23, 1999
DATES: Submit written comments on the collection of information by August 23, 1999. … In the Federal Register of March 4, 1999 (64 FR 10470), the agency requested comments on the proposed collections of information. No comments were received.
64 FR 40008Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Oct 24, 2002
Therefore, we invite comment on ways to ensure that only appropriate product by process patents are listed, while maintaining the act's restriction against listing process patents. 2. … a second notice to the patent owner and NDA holder, and the 45-day period for filing a patent infringement suit, as described in section 505(j)(5)(B)(iii) of the act, will not have run.
67 FR 65448Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Oct 3, 2005
The interim final rule responded to comments from the public on the proposed rule, and established a 75-day comment period on a limited set of issues identified in the interim final rule and also set out … system, FDA reopened the comment period on the same limited set of issues for 30 days on April 14, 2004 (69 FR 19766).
70 FR 57505Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 27, 2004
(the act) designed to assure the adequate labeling of prescription (Rx) drugs. … Under section 502(a) of the act (21 U.S.C. 352(a)), a drug product is misbranded if its labeling is false or misleading in any particular, and under section 201(n) of the act (21 U.S.C. 321(n)), a drug's
69 FR 3921Health and Human Services DepartmentFood and Drug Administration
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