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Federal Register · Notice · Apr 28, 2020
For example, a recognized accreditation body agrees to attend training, regularly communicate with FDA, and support periodic FDA audits. … For example, an ASCA-accredited testing laboratory agrees to attend training, regularly communicate with FDA, and support periodic FDA audits.
85 FR 23521Health and Human Services DepartmentFood and Drug AdministrationAnimal Drug Availability Act; Veterinary Feed Directive
Federal Register · Rule · Dec 8, 2000
Fairness Act of 1996 (Public Law 104-121)), and the Unfunded Mandates Reform Act of 1995 (Public Law 104-4). … with a zero tolerance because of a carcinogenic concern regardless of whether a withdrawal period is required, or are a veterinary feed directive drug
65 FR 76924Health 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 AdministrationGuidance for Industry on Bioequivalence Recommendations for Specific Products; Availability
Federal Register · Notice · Jun 11, 2010
For draft BE recommendations, the Federal Register notice will identify a comment period. … Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2010-14036 Filed 6-10-10; 8:45 am] BILLING CODE 4160-01-S
75 FR 33311Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 5, 2022
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. … The report must cover the period of the preceding calendar year and include separate information for each month of the calendar year.
87 FR 26764Health and Human Services DepartmentFood and Drug AdministrationMedical Devices; Mammography Quality Standards Act of 1992; Inspection Fees
Federal Register · Notice · Jan 14, 1998
Submit written comments by March 16, 1998. … Request for Comments Although the MQSA does not require FDA to solicit comments on fee exemption, assessment and collection, FDA is inviting comments from interested persons in order to have the benefit
63 FR 2245Food 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 AdministrationEffective Date of Requirement for Premarket Approval for Three Class III Preamendments Devices
Federal Register · Rule · Aug 16, 2011
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 closed November 23, 2010. FDA received no comments on the proposed rule.
76 FR 50663Health 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 AdministrationFederal Register · Notice · Jan 27, 1999
In the Federal Register of October 6, 1998 (63 FR 53675), the agency requested comments on the proposed collection of information. No comments were received. … Section 814.84 specifies the contents of periodic reports. [[Page 4113]] II.
64 FR 4112Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 19, 1999
(the act) (21 U.S.C. 360j(m)) and 21 CFR part 814 subpart H. … FDA also estimates that it will take an average of 120 staff hours to complete a periodic report as a result of this amendment. B.
64 FR 38673Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 4, 2021
FDA issued part 810 to implement the provisions of section 518 of the FD&C Act. … Section 810.16(a) and (b)—Periodic Status Reports—(Reporting)—The person named in a cease distribution and notification order or a mandatory recall order must submit periodic status reports to FDA to enable
86 FR 41973Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Dec 17, 2019
for the efficient enforcement of the FD&C Act. … Mandates Reform Act of 1995 (Pub.
84 FR 68829Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 7, 2011
To comply with this requirement, in the Federal Register of May 20, 2010 (75 FR 28257), FDA published a notice of availability of the draft guidance document providing a 60-day public comment period … Description: Section 228 of the Food and Drug Administration Amendments Act of 2007 (FDAAA), amended section 704(g)(7) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 374(g)(7)) to add the following
76 FR 39880Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 19, 2010
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 … Medical Device User Fee Cover Sheet—Form FDA 3601—OMB Control Number 0910-0511—Extension The Federal Food, Drug, and Cosmetic Act, as amended by the Medical Device User Fee and Modernization Act of
75 FR 2866Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 29, 2001
Section 314.50(j) requires that applicants that request a period of marketing exclusivity submit certain information with the application. … Other interested persons may also submit comments on the notice.
66 FR 29143Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 10, 2004
This notice solicits comments on information collection requirements for medical devices; third-party review under the Food and Drug Modernization Act of 1997 (FDAMA). … Third-party reviews should maintain records of their 510(k) reviews and a copy of the 510(k) for a reasonable period of time, usually a period of 3 years.
69 FR 48508Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 10, 2011
ACTION: Notice; request for comments. … It is only necessary to send one set of comments. It is no longer necessary to send two copies of mailed comments.
76 FR 27062Health 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 Administration
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