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Federal Register · Notice · Feb 25, 1998
DATES: Written comments may be submitted at any time. ADDRESSES: Submit written comments concerning this guidance document to the contact person listed below. … Request for Comments Interested persons, may at any time, submit to the contact person listed above written comments regarding this guidance document.
63 FR 9569Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Jul 27, 2015
Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by August 26, 2015, (see the “Paperwork Reduction Act of 1995” section of this document). … In the Federal Register of May 27, 2014 (79 FR 30055), we extended the comment period until August 1, 2014.
80 FR 44303Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · May 24, 2022
in effect even after the HHS Secretary declares that this PHE no longer exists or the expiration of the 90-day period beginning on the date the HHS Secretary issues a renewal of the determination that … Paperwork Reduction Act of 1995 Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection
87 FR 31440Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Jun 12, 1996
The requirements for comments are found in section 572.603 of Title 46 of the Code of Federal Regulations. … The parties have requested a shortened review period. Agreement No.: 224-200989. Title: Port of Galveston/Suderman Contracting Stevedores, Inc. Terminal Agreement.
61 FR 29701Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 15, 2019
Section 210 of the Food and Drug Administration Modernization Act of 1997 (FDAMA) established section 523 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360m), directing FDA to accredit … Third-party reviewers should maintain records of their 510(k) reviews and a copy of the 510(k) for a reasonable period of time, usually 3 years.
84 FR 55155Health and Human Services DepartmentFood and Drug AdministrationKalpen D. Patel: Final Debarment Order
Federal Register · Notice · Feb 14, 2024
the FD&C Act). … Patel during his period of debarment, other than in connection with an audit under section 306(c)(1)(B) of the FD&C Act.
89 FR 11296Health and Human Services DepartmentFood and Drug AdministrationFood Labeling: Health Claims; Omega-3 Fatty Acids and the Risk in Adults of Cardiovascular Disease
Federal Register · Rule · Jun 22, 1998
comment and publication of a final regulation'' if the agency ``determines that such action is necessary * * * to enable [FDA] to act promptly to ban or modify a claim'' under section 403(r) of the act … FDA invites public comment on this interim final rule. The agency will consider modifications to this interim final rule based on comments made during the comment period.
63 FR 34107Health and Human Services DepartmentFood and Drug AdministrationAgency Information Collection Activities; Submission for OMB Review; Comment Request
Federal Register · Notice · Jun 9, 1998
Statutory authority for the collection of this information is provided by sections 505(a), (b), (j), and (k), 507(g), and 701(a) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355(a), … In the same period of time, CBER received 1, 034 submissions from 57 manufacturers that could have made use of revised Form FDA 2253.
63 FR 31503Health and Human Services DepartmentFood and Drug AdministrationInvestigational Device Exemptions; Treatment Use
Federal Register · Rule · Sep 18, 1997
(the act) (21 U.S.C. 360e) or an approved IDE under section 520(g) of the act (21 U.S.C. 360j(g)). … Regulatory Fairness Act of 1996 (Pub.
62 FR 48940Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 8, 2009
Most information is already required to be submitted under section 510 of the act, section 351 of the Public Health Service Act, and part 207. … In the Federal Register of July 11, 2008 (73 FR 39964), FDA published a notice of availability of the draft guidance document providing a 60-day public comment period on the information collection
74 FR 816Health and Human Services DepartmentFood and Drug AdministrationProduct-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability
Federal Register · Notice · Nov 21, 2025
Under that process, draft guidances are posted on FDA's website and announced periodically in the Federal Register . … The previously approved collections of information are subject to review by OMB under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521).
90 FR 52681Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 9, 2016
(the FD&C Act). … Act of 1995 (the PRA) (44 U.S.C. 3501-3520).
81 FR 62509Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Apr 18, 2017
Background On July 12, 2012, FDA approved a risk evaluation and mitigation strategy (REMS) for extended release (ER) and long-acting (LA) opioid analgesic medications (ER/LA Opioid Analgesics REMS). … Requests for Oral Comments: During online registration you may indicate if you wish to provide a statement during the Open Public Comment Period.
82 FR 18300Health and Human Services DepartmentFood and Drug AdministrationImpact of Approved Drug Labeling on Chronic Opioid Therapy; Public Hearing; Request for Comments
Federal Register · Notice · Dec 19, 2012
ACTION: Notice of public hearing; request for comments. … What are and should be the time periods that characterize short-term pain versus chronic pain? b.
77 FR 75177Health and Human Services DepartmentFood and Drug AdministrationHuman Cells, Tissues, and Cellular and Tissue-Based Products; Establishment Registration and Listing
Federal Register · Rule · Jan 27, 2004
ACTION: Interim final rule; opportunity for public comment. … Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy.
69 FR 3823Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Nov 7, 2016
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 … cruzi and positive on a licensed supplemental test, we recommend that the establishment notify consignees of all previously distributed blood and blood components collected during the lookback period
81 FR 78170Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 31, 2026
This notice solicits comments on the information collection pertaining to the registration of human drug compounding outsourcing facilities under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and … Registered outsourcing facilities must submit a drug product report upon initial registration under section 503B and twice each year in June and December for drug products produced during the previous 6-month period
91 FR 55857Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Feb 18, 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. … FDA is reopening the 30-day comment period in order to satisfy PRA requirements. No changes have been made to the information collection. Grace R.
91 FR 7496Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 23, 2013
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 … For many studies, continuing review can be fairly straightforward, and the IRB should be able to complete its deliberations and approve the research within a brief period of time.
78 FR 44126Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Feb 6, 2017
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 and to allow 60 days for … Vacancies are updated periodically; therefore, one or more vacancies listed may be in the nomination process or a final appointment may have been made.
82 FR 9383Health and Human Services DepartmentFood and Drug Administration
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