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Federal Register · Notice · Aug 11, 2020
Section 417(g) of the FD&C Act requires that responsible persons maintain records related to reportable foods for a period of 2 years. … Recordkeeping: As noted previously, section 417(g) of the FD&C Act requires that responsible persons maintain records related to reportable foods reports and notifications for a period of 2 years.
85 FR 48542Health and Human Services DepartmentFood and Drug AdministrationEffective Date of Requirement for Premarket Approval for a Pacemaker Programmer
Federal Register · Rule · Jun 22, 2012
Section 515(b)(3) of the FD&C Act provides that FDA shall, after the close of the comment period on the proposed rule and consideration of any comments received, issue a final rule to require premarket … The comment period for the pacemaker programmer electrode closed November 2, 2011. FDA received one comment on the August 2011 proposed rule for the pacemaker programmer.
77 FR 37570Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Nov 30, 1999
DATES: Submit written comments by February 28, 2000. Submit written comments on the information collection provisions by December 30, 1999. … Paperwork Reduction Act of 1995 This rule contains information collection requirements that are subject to public comment and review by the Office of Management and Budget (OMB) under the Paperwork
64 FR 66822Health and Human Services DepartmentFood and Drug AdministrationFood Labeling; Serving Sizes; Reference Amount for Baking Powder, Baking Soda, Pectin
Federal Register · Proposed Rule · Nov 18, 1997
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 $200 per firm. VIII.
62 FR 61476Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Mar 6, 2020
The Federal Food, Drug, and Cosmetic Act (FD&C Act) requires that before FDA begins negotiations with the regulated industry on MDUFA reauthorization, we publish a notice in the Federal Register requesting … This notice, the public meeting, the 30-day comment period after the meeting, and the posting of the comments on FDA's website will satisfy these requirements.
85 FR 13165Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Mar 12, 2024
Under the Public Health Service Act (PHS Act) (42 U.S.C. 262), FDA may only approve a biologics license application for a biological product that is safe, pure, and potent. … We received one comment regarding our estimate of 28 hours per response for periodic adverse experience reports.
89 FR 17858Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Dec 1, 2003
Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. … (1) 333(b)(2)(A) Violation of certain requirements of the Prescription Drug Marketing Act (PDMA) 50,000 For each of the first two violations in any 10-year period ---- 55,000 (2)
68 FR 67094Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Sep 17, 2015
We reopened the comment period on March 13, 2013 (78 FR 15894) and also extended the comment period on April 26, 2013 (78 FR 24693). … Response to Public Comments,” 2015.
80 FR 56358Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 10, 2009
U.S.C. 262 and 264) and the provisions of the Federal Food, Drug, and Cosmetic Act that apply to drugs (21 U.S.C. 301 et seq. ). … These characteristics include long latency periods and the ability to establish persistent infections.
74 FR 33260Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 14, 2012
(42 U.S.C. 262 and 264) and the provisions of the Federal Food, Drug, and Cosmetic Act that apply to drugs (21 U.S.C. 301 et seq. ). … These characteristics include long latency periods and the ability to establish persistent infections.
77 FR 35683Health and Human Services DepartmentFood and Drug AdministrationRevision of the Definition of the Term “No Residue”
Federal Register · Proposed Rule · Jan 17, 2002
(the act) (21 U.S.C. 348, 360b, and 379e). … Comments Interested persons may submit to the Dockets Management Branch (address above) written or electronic comments regarding this proposal by April 17, 2002.
67 FR 2384Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 20, 2009
We encourage sponsors to send in applications as soon as possible to allow sufficient time for review, comment, and resubmission as needed to complete all actions by the end of this 2-year period. … Paperwork Reduction Act of 1995 This draft guidance refers to previously approved collections of information found in FDA regulations.
74 FR 53751Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Apr 13, 2011
section 505(b) or 505(j) of the FD&C Act is effective with respect to such drug. … Other interested persons may also submit comments on the notice.
76 FR 20680Health and Human Services DepartmentFood and Drug AdministrationOrthopedic Devices: Classification and Reclassification of Pedicle Screw Spinal Systems
Federal Register · Rule · Jul 27, 1998
Subsequently, in the Federal Register of December 29, 1995 (60 FR 67345), FDA extended the comment period until March 4, 1996, in response to several requests for extension of the comment period. ----- … FDA agrees that a 12-month followup time period would be inadequate and, therefore, selected a 24-month followup period for analysis.
63 FR 40025Health and Human Services DepartmentFood and Drug AdministrationHealth Claim; Phytosterols and Risk of Coronary Heart Disease
Federal Register · Proposed Rule · Feb 18, 2011
DATES: Submit either electronic or written comments by April 19, 2011 . ADDRESSES: Submit electronic comments to http://www.regulations.gov. … Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2011-3678 Filed 2-17-11; 8:45 am] BILLING CODE 4160-01-P
76 FR 9525Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 11, 2026
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. … In the Federal Register of February 19, 2026 (91 FR 8010), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received.
91 FR 35484Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 19, 2018
The comment period on the draft guidance ended on October 11, 2016. FDA received approximately 88 comments on the draft guidance. … For example, in response to requests in comments for direction on records retention, FDA added a recommendation that compounders maintain the records described in the guidance for a period of at least
83 FR 2790Health and Human Services DepartmentFood and Drug AdministrationPhibro Animal Health Corp.; Carbadox in Medicated Swine Feed; Revocation of Approved Method
Federal Register · Notice · Jul 20, 2020
See section 512(d)(1)(I) of the FD&C Act. … See section 512(d)(1)(I) of the FD&C Act.
85 FR 43853Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Mar 4, 2020
Current Good Manufacturing Practice Regulations for Medicated Feeds—21 CFR Part 225 OMB Control Number 0910-0152—Extension Under section 501 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) ( … as to safety, and also that they meet their claimed identity, strength, quality, and purity, as required by section 501(a)(2)(B) of the FD&C Act.
85 FR 12790Health and Human Services DepartmentFood and Drug AdministrationRevision of the Requirements for Publication of License Revocation; Confirmation of Effective Date
Federal Register · Rule · Aug 21, 2009
FDA solicited comments concerning the direct final rule for a 75-day period ending July 20, 2009. … the comment period.
74 FR 42175Health and Human Services DepartmentFood and Drug Administration
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