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Quality Metrics Technical Conformance Guide-Technical Specifications Document; Availability
Federal Register · Notice · Jun 27, 2016
We note that the comment period for that draft guidance closed in November 2015 and that the comments that were received are undergoing evaluation. … Paperwork Reduction Act of 1995 This guide refers to previously approved collections of information that are subject to review by the Office of Management and Budget under the Paperwork Reduction Act
81 FR 41545Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Apr 20, 2016
The public comment period closed on June 25, 2003. A number of comments were received, which the Agency considered carefully as it prepared this revised draft guidance. … Paperwork Reduction Act of 1995 This draft guidance contains information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act
81 FR 23303Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 11, 2016
In the Federal Register of April 9, 2014 (79 FR 19622), the Agency announced that the deadline for the comment period would be extended until May 7, 2014, to allow for more public comments on this … Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information found in FDA regulations and guidance.
81 FR 70120Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 14, 2017
of 2002 (the Bioterrorism Act) added section 414 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 350c), which requires that persons who manufacture, process, pack, hold, receive, … Existing records may be used if they contain all of the required information and are retained for the required time period. Section 101 of the FDA Food Safety Modernization Act (FSMA) (Pub.
82 FR 27263Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Mar 27, 2024
Therefore, designated countries may respond to our periodic requests by submitting information to confirm their designations remain appropriate. … Although three comments were received, the comments were not responsive to the four collection of information topics solicited.
89 FR 21257Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 17, 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 … These collections of information are subject to review by the OMB under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
83 FR 2451Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 27, 2014
Some of the commenters may have been confusing disclosure of registration information with disclosure of proprietary information required to be reported under section 503B(b)(2) of the FD&C Act. … Health and Human Services as an outsourcing facility shall submit to the Secretary a report providing certain information about the drugs that were compounded by the facility during the previous 6-month period
79 FR 51176Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Aug 27, 1998
, as amended by the FDA Modernization Act of 1997 (FDAMA). … The comment period closed July 27, 1998. FDA is withdrawing the direct final rule because the agency received significant adverse comment.
63 FR 45716Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Jul 20, 2010
The comment period closed on June 15, 2010. FDA is withdrawing the direct final rule because the agency received significant adverse comment. … Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2010-17617 Filed 7-19-10; 8:45 am] BILLING CODE 4160-01-S
75 FR 41986Health and Human Services DepartmentFood and Drug AdministrationMedical Devices; Exemptions From Premarket Notification: Class II Devices
Federal Register · Rule · Jul 22, 2020
This section requires FDA to publish in the Federal Register a notice of intent to exempt a device, or of the petition, and provide a 60-calendar-day comment period. … Having received no comments to the docket following a 60-day comment period, FDA is issuing this order to set forth our final determination to exempt the class II devices that were the subject of the notice
85 FR 44186Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Apr 25, 2017
Administration (FDA or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act … diagnostic testing of the donor indicating T. cruzi infection, we recommend that the establishment notify consignees of all previously distributed blood and blood components collected during the lookback period
82 FR 19062Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 19, 2003
Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act … During that 4-year period, an average of five antimicrobial NADAs (including original and major supplements) was approved in food-producing animals per year.
68 FR 54906Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Feb 18, 2021
Under the Safe Medical Devices Act of 1990 (Pub. … (FD&C Act) (21 U.S.C. 360(k)) clearance.
86 FR 10108Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 7, 2014
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 and to allow 60 days … for public comment in response to the notice.
79 FR 26252Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 11, 2016
Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act … There are 42 State programs enrolled, in which each State may receive up to $300,000 each year for a period of 5 years provided there is significant conformance with the 10 standards.
81 FR 53148Health and Human Services DepartmentFood and Drug AdministrationCalgene, Inc.; Availability of Letter Concluding Consultation
Federal Register · Uncategorized Document · May 23, 1994
the act) with respect to foods derived from new plant varieties. … The written summary includes a response to the comments received on the Calgene advisory opinion request, including comments contained in a citizen petition (Docket No. 92P- 0222/CP1) filed in accordance
Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Feb 21, 2002
The information is critical to the agency’s mission of regulating food labeling and is needed prior to the expiration of the normal time periods for OMB clearance under the PRA regulations (5 CFR part … Under section 903(d)(2)(C) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 393(d)(2)(C)), FDA is authorized to conduct research related to food labeling.
67 FR 8030Health and Human Services DepartmentFood and Drug AdministrationEar, Nose, and Throat Devices; Reclassification of Endolymphatic Shunt Tube With Valve
Federal Register · Proposed Rule · Aug 15, 2001
The period for requesting a change in the classification of the device closed on May 21, 1990. The period for commenting on the proposed rule closed on July 3, 1990. … FDA did not receive any comments on the proposed rule.
66 FR 42809Health and Human Services DepartmentFood and Drug AdministrationNonproprietary Naming of Biological Products; Guidance for Industry; Availability
Federal Register · Notice · Jan 13, 2017
be licensed under section 351 of the PHS Act on March 23, 2020 (section 7002(e)(2) through (e)(4) of the Biologics Price Competition and Innovation Act of 2009 (BPCI Act)). … This estimate for submission of the requested information is based on the average number of responses per respondent and the average burden per response over a 3-year period.
82 FR 4345Health and Human Services DepartmentFood and Drug AdministrationAgency Information Collection Activities; Submission for OMB Review; Comment Request
Federal Register · Notice · Jul 23, 1998
FDA's response to this comment is twofold. … This is because the numbers in the previous estimate were too low and represented a study period of only 6 months, which is not enough time to obtain interviews both before and after the final implementation
63 FR 39581Health and Human Services DepartmentFood and Drug Administration
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