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Doyal Kalita: Final Debarment Order
Federal Register · Notice · Aug 19, 2025
SUMMARY: The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Doyal Kalita for a period of 10 years from importing or offering … In proposing a debarment period, FDA weighed the considerations set forth in section 306(c)(3) of the FD&C Act that it considered applicable to Mr.
90 FR 40369Health and Human Services DepartmentFood and Drug AdministrationEffective Date of Requirement for Premarket Approval for Two Class III Preamendments Devices
Federal Register · Proposed Rule · Jan 18, 2013
Paperwork Reduction Act of 1995 X. Proposed Effective Date XI. Comments XII. References I. … Section 515(b)(3) of the FD&C Act provides that FDA shall, after the close of the comment period on the proposed order, consideration of any comments received, and a meeting of a device classification
78 FR 4094Health and Human Services DepartmentFood and Drug AdministrationAmended Procedures for Advisory Panel Meetings; Draft Guidance; Availability
Federal Register · Notice · Mar 31, 1998
After the close of the comment period, written comments may be submitted at any time to the contact person listed below. … ADDRESSES: Written comments concerning the draft guidance that are submitted within the 90 days comment period must be addressed to the Dockets Management Branch (HFA-305), Food and Drug Administration
63 FR 15426Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 22, 2017
Section 417(g) of the FD&C Act requires that responsible persons maintain records related to reportable foods for a period of 2 years. … &C Act for a period of 2 years.
82 FR 44422Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 25, 2014
Section 417(g) of the FD&C Act requires that responsible persons maintain records related to reportable foods for a period of 2 years. … Act for a period of 2 years.
79 FR 50656Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 11, 2020
Section 417(g) of the FD&C Act requires that responsible persons maintain records related to reportable foods for a period of 2 years. … Recordkeeping: As noted previously, section 417(g) of the FD&C Act requires that responsible persons maintain records related to reportable foods reports and notifications for a period of 2 years.
85 FR 48542Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Nov 19, 2007
210 of the Food and Drug Administration Modernization Act (FDAMA) established section 523 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360m), directing FDA to accredit persons in the … 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 a period of 3 years.
72 FR 65038Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Nov 18, 2009
DATES: Fax written comments on the collection of information by December 18, 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
74 FR 59545Health and Human Services DepartmentFood and Drug AdministrationCivil Money Penalties: Biologics, Drugs, and Medical Devices
Federal Register · Rule · Jul 27, 1995
to most motions, a period that may include only 5 business days. … (a) In computing any period of time under this part or in an order issued thereunder, the time begins with the day following the act or event, and includes the last day of the period, unless either such
60 FR 38612Justice DepartmentHealth and Human Services DepartmentFederal Register · Notice · Apr 23, 2026
FDA is adding 18 new constituents to the established list consistent with the requirement in section 904(e) of the FD&C Act to periodically revise, as appropriate, the established HPHC list (Table 1). … This determination may be revised, consistent with the directive in section 904(e) of the FD&C Act that FDA periodically revise the established list as appropriate.
91 FR 21824Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Feb 23, 2012
FDA invites public comment on this IFR and will consider modifications to it based on comments made during the comment period when FDA issues the final rule. … FDA intends to finalize this IFR 1 year from the close of the comment period.
77 FR 10658Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Feb 7, 2020
DATES: Fax written comments on the collection of information by March 9, 2020. … 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
85 FR 7311Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Mar 24, 2004
In response to two requests for extension of time to file comments to the proposed rule, FDA published a notice in the Federal Register of July 22, 1996 (61 FR 38047), extending the comment period … (the act).
69 FR 13725Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 23, 2024
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. … helps support implementation of sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 353a and 21 U.S.C. 353b), which govern compounding by pharmacies, outsourcing facilities
89 FR 77528Health and Human Services DepartmentFood and Drug AdministrationEffective Date of Requirement for Premarket Approval for a Pacemaker Programmer
Federal Register · Rule · Jun 22, 2012
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 for the pacemaker programmer electrode closed November 2, 2011. FDA received one comment on the August 2011 proposed rule for the pacemaker programmer.
77 FR 37570Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 29, 2008
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 … DATES: Submit written or electronic comments on the collection of information by November 28, 2008.
73 FR 56592Health and Human Services DepartmentFood and Drug AdministrationHealth Claim; Phytosterols and Risk of Coronary Heart Disease
Federal Register · Proposed Rule · Feb 18, 2011
DATES: Submit either electronic or written comments by April 19, 2011 . ADDRESSES: Submit electronic comments to http://www.regulations.gov. … Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2011-3678 Filed 2-17-11; 8:45 am] BILLING CODE 4160-01-P
76 FR 9525Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 21, 2007
This notice solicits comments on information collection requirements for “Medical Devices Third-Party Review under the Food and Drug Administration Modernization Act of 1997 (FDAMA).” … 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 a period of 3 years.
72 FR 34257Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Nov 3, 2023
FDA will review any comments submitted within the 60-day comment period and will consider whether any modifications should be made to the exemption for certain clinical electronic thermometers prior to … Additionally, FDA must provide at least a 60-day comment period for any such notice published under section 510(m)(1)(A) of the FD&C Act.
88 FR 75602Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 7, 2010
In the Federal Register of September 15, 2009 (74 FR 47257), FDA published a notice correcting the length of the comment period, keeping it open until October 1, 2009. … In the Federal Register of October 13, 2009 (74 FR 52495), FDA published a notice reopening the comment period until October 26, 2009.
75 FR 25267Health and Human Services DepartmentFood and Drug Administration
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