Documents
Briefs, oral arguments, agency decisions and the Federal Register.
5,436 results
0.25s
Federal Register · Notice · Jan 19, 2017
The comment period will be reopened for 90 days, until April 19, 2017. … Paperwork Reduction Act of 1995 Under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each
82 FR 6575Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 30, 2009
Seven comments were received in response to the 60-day notice. Of the seven comments received, six related to the guidance and the information collection requests. … FDA based these estimates on the number of original HDE applications that the Center for Devices and Radiological Health (CDRH) received in the period between October 1, 2004, and September 30, 2007.
74 FR 50214Health and Human Services DepartmentFood and Drug AdministrationGuidance for Industry on Expedited Programs for Serious Conditions-Drugs and Biologics; Availability
Federal Register · Notice · May 30, 2014
Section 901(c)(2) of FDASIA requires FDA to issue a final guidance document to implement amendments to the Federal Food, Drug, and Cosmetic Act (the FD&C Act) made by section 901 of FDASIA (Enhancement … Section 902(b)(1)(A) of FDASIA requires FDA to issue a guidance document to implement requirements of section 902 (Breakthrough Therapies) within 1 year of the date the comment period closes for the draft
79 FR 31117Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 19, 2005
by the Center for Veterinary Medicine” has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. … FDA periodically will review the comments in the docket, and where appropriate, will amend the guidance.
70 FR 41406Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 8, 2008
The comment period for the draft guidance closed on September 18, 2006. During this time, FDA received one set of comments from a device manufacturer concerning the draft guidance. … Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information found in FDA regulations.
73 FR 1359Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 1, 2009
for an additional 1-year period (i.e., for dietary supplements labeled before January 1, 2010) because the agency was still in the process of reviewing the comments and finalizing the guidance. … Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy.
74 FR 45221Health and Human Services DepartmentFood and Drug AdministrationPrescription Drug User Fee Act (PDUFA) II Five-Year Plan Revision; Availability
Federal Register · Notice · Aug 27, 1999
This revised plan updates FDA's anticipated prescription drug user fee revenues and planned expenditures of the fee revenues over the 5-year period from 1998 to 2002. … Two copies of any comments are to be submitted, except that individuals may submit one copy. Comments are to be identified with the docket number found in brackets in the heading of this document.
64 FR 46918Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Mar 16, 2009
Background The Medical Device User Fee and Modernization Act of 2002 (MDUFMA) (Public Law 107-250) amends the Federal Food, Drug, and Cosmetic Act (the act) to provide FDA new responsibilities and resources … The primary difference between this draft guidance and the November 24, 2003, version now in effect is the addition of user fee and user fee refund information for 30-day notices and periodic reports.
74 FR 11117Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 10, 2018
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 … 80 8,800 Notification of withdrawal of an HDE—814.116(e)(3) 1 1 1 1 1 Notification of withdrawal of Institutional Review Board approval—814.124(b) 1 1 1 2 2 Periodic
83 FR 1263Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 13, 2012
The Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) (Pub. … The commenter also provided comments that were not PRA-related and are beyond the scope of this document.
77 FR 74194Health and Human Services DepartmentFood and Drug AdministrationProposed Warning Labels for Iron-Containing Products; FDA Report on Consumer Research; Availability
Federal Register · Notice · May 23, 1995
FDA is inviting comments on the findings in this report. DATES: Written comments by July 24, 1995. … After the comment period shown above, copies of the document will be available at cost from the Freedom of Information Staff (HFI-35), Food and Drug Administration, rm. 12A-16, 5600 Fishers Lane, Rockville
60 FR 27321Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 16, 2009
Administrative Detention and Banned Medical Devices (OMB Control Number 0910-0114)—Extension FDA has the statutory authority under section 304(g) of the Federal Food, Drug, and Cosmetic Act (the act … These recordkeeping requirements for administrative detentions pemits FDA to trace devices for which the detention period expired before a seizure is accomplished or injunctive relief is obtained.
74 FR 53257Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 13, 2022
Under section 705 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 375), the Secretary of the Department of Health and Human Services (the Secretary) may require dissemination of information … We have identified 24 DHCP letters that 18 distinct sponsors submitted to FDA during the 3-year period (2019 to 2021).
87 FR 76203Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 1, 2002
The guidance was made available as a draft for comment on December 7, 2001 (66 FR 63546). The comment period closed March 7, 2002. FDA received two comments, both agreeing with FDA's recommendation. … Paperwork Reduction Act of 1995 This guidance contains information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995
67 FR 44218Health and Human Services DepartmentFood and Drug AdministrationCrabmeat; Amendment of Common or Usual Name Regulation
Federal Register · Proposed Rule · Apr 23, 1998
(the act) (21 U.S.C. 343(b)). … Comments Interested persons may on or before July 7, 1998, submit to the Dockets Management Branch (address above) written comments regarding this proposal.
63 FR 20148Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 24, 2008
Infant Formula Recall Regulations—(OMB Control Number 0910-0188)—Extension Section 412(e) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 350a(e)) provides that if the manufacturer … Manufacturers keep infant formula distribution records for the prescribed period as a matter of routine business practice.
73 FR 35699Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 23, 2011
New Animal Drugs for Investigational Uses—21 CFR Part 511 (OMB Control Number 0910-0117)—Extension FDA has the authority under the Federal Food, Drug, and Cosmetic Act (FD&C Act) to approve new animal … maintain records showing the name and post office address of the expert or expert organization to whom it is shipped and the date, quantity, and batch or code mark of each shipment and delivery for a period
76 FR 59139Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 15, 2008
Section 760(e) of the act also requires that responsible persons maintain records of nonprescription drug adverse event reports, whether or not the event is serious, for a period of 6 years. … No comments were received on the information collection.
73 FR 53251Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Jan 5, 2016
within which such labeling or change in labeling was to be done, such labeling or change in labeling was not done within such period. … One author in that report switched to the mesh-augmented technique part way through the period covered by the study due to dissatisfaction with native tissue repair.
81 FR 354Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Nov 24, 2014
The guidance addresses new provisions in the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Drug Quality and Security Act (DQSA). … The comment period on the draft guidance ended on February 3, 2014. FDA received nine comments on the draft guidance.
79 FR 69859Health and Human Services DepartmentFood and Drug Administration
Ask Donna what matters in the record.
She can read the source against your case and show you exactly where the answer came from.