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Federal Register · Notice · Apr 4, 2003
the act. … Comments Interested persons may submit to the Dockets Management Branch (see ADDRESSES ) written or electronic comments regarding this guidance.
68 FR 16520Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Uncategorized Document · Mar 14, 1994
Paperwork Reduction Act of 1980 VI. Environmental Impact VII. Request for Comments I. Background On April 22, 1988, the President signed PDMA into law (Pub. L. 100- 293). … Sometimes the period of time is only a few minutes, but often it may be hours, days, or weeks.
Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Feb 3, 2016
Background Section 226 of the Food and Drug Administration Amendments Act of 2007 (Pub. L. 110-85) and Section 614 of the Food and Drug Administration Safety and Innovation Act (Pub. … FDA is particularly interested in receiving information relating to the following question: • Is a time period through September 24, 2018, an appropriate amount of additional time for stakeholders to
81 FR 5760Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 14, 2014
This draft guidance has been revised and is being reissued for comment because the Food and Drug Administration Safety and Innovation Act (FDASIA), which became law on July 9, 2012, amended the FD&C Act … The comment period closed on December 2, 2011.
79 FR 47651Health and Human Services DepartmentFood and Drug AdministrationWillis Reed: Final Debarment Order
Federal Register · Notice · Mar 21, 2024
the FD&C Act). … Reed during his period of debarment, other than in connection with an audit under section 306 of the FD&C Act (section 306(c)(1)(B) of the FD&C Act (21 U.S.C. 335a(c)(1)(B))).
89 FR 20205Health and Human Services DepartmentFood and Drug AdministrationState Certification of Mammography Facilities
Federal Register · Proposed Rule · Mar 30, 2000
DATES: Submit written comments on the proposed rule by June 28, 2000. Written comments on the information collection requirements should be submitted by May 1, 2000. … Act.
65 FR 16847Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 28, 2009
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 … A source previously found to contain E. coli will be considered negative for E. coli after five samples collected over a 24-hour period from the same sampling site are tested and found to be
74 FR 55557Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 25, 2025
(the act) regarding safety, identity, strength, quality, and purity. … All records and documentation referenced in this part must be maintained for a period of at least 1 year from the date of final release, including conditional final release, of a PET drug product.
90 FR 46218Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 10, 2011
for public comment in response to the notice. … Estimate of survey respondents was based on an estimate of the ideal number of usability surveys that FDA would conduct over a 3-year period.
76 FR 34083Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Apr 21, 2004
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 … Use of the same questions in both time periods will enable comparison between the two data collections.
69 FR 21548Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 8, 2021
Similarly, during the same period, 6,287 recalls were terminated, for an average of 2,095 recall terminations annually, and we assume an average of 10 hours is needed for the corresponding information … Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2021-00125 Filed 1-7-21; 8:45 am] BILLING CODE 4164-01-P
86 FR 1508Health and Human Services DepartmentFood and Drug AdministrationObstetrical and Gynecological Devices; Classification of Female Condoms
Federal Register · Rule · May 18, 2000
The 90-day comment period ended September 8, 1999, and FDA stated that upon consideration of public comment it would issue a final rule classifying this device. … FDA received one comment endorsing the June 10, 1999, proposal. II.
65 FR 31454Health and Human Services DepartmentFood and Drug AdministrationSanitary Transportation of Human and Animal Food; Public Meetings on Proposed Rule
Federal Register · Proposed Rule · Feb 14, 2014
(2005 SFTA) and the FDA Food Safety Modernization Act (FSMA). … period.
79 FR 8907Health and Human Services DepartmentFood and Drug AdministrationOver-the-Counter Sunscreen Drug Products-Regulatory Status of Enzacamene
Federal Register · Proposed Rule · Feb 25, 2015
Publication of a proposed sunscreen order triggers several timelines under the SIA, including a 45-day public comment period, and a 30-day period in which a sponsor may request a meeting with FDA to discuss … Comments Similarly, section 586C(b)(6) of the FD&C Act, as amended by the SIA, establishes that a proposed sunscreen order shall provide 45 days for public comment.
80 FR 10026Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Jan 16, 2025
In response to a written request submitted to the docket, we extended the comment period to May 18, 2023 (88 FR 19026, March 30, 2023). … Section 721(b)(5)(c)(i) of the FD&C Act states that any person who will be adversely affected by a proposal if placed into effect may request, within the specified time period, that the petition or order
90 FR 4628Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 6, 2005
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 … During that period, microbial food safety for approximately 15 antimicrobial NADAs (including original and major supplements) was evaluated.
70 FR 1253Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 23, 2020
OMB Control Number 0910-0850—Extension Section 2011 of the 21st Century Cures Act of 2016 (Pub. … The guidance further outlines the process by which administrators 1 of genetic variant databases could voluntarily apply to FDA for recognition, and how FDA would review such applications and periodically
85 FR 59801Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Mar 21, 2023
Section 301(a) of the FD&C Act (21 U.S.C. 331(a)) prohibits the introduction or delivery for introduction into interstate commerce of adulterated food. … The records of processing information are periodically reviewed during factory inspections by FDA to verify fulfillment of the requirements in parts 113 or 114.
88 FR 16990Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Mar 4, 2016
(the FD&C Act). … Repair: Return the device or component to original specifications including replacing non-working components or parts outside of routine or periodic upkeep for the current owner of the device. 4.
81 FR 11477Health and Human Services DepartmentFood and Drug AdministrationProduct-Specific Guidances; Revised Draft Guidances for Industry; Availability
Federal Register · Notice · Jul 29, 2026
Under that process, draft guidances are posted on FDA's website and announced periodically in the Federal Register . … Paperwork Reduction Act of 1995 While these guidances contain no collection of information, they do refer to previously approved FDA collections of information.
91 FR 47834Health and Human Services DepartmentFood and Drug Administration
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