Documents
Briefs, oral arguments, agency decisions and the Federal Register.
5,436 results
0.23s
Food Labeling: Nutrient Content Claims, Expansion of the Nutrient Content Claim “Lean”
Federal Register · Rule · Jan 12, 2007
(Nestlé) under the Federal Food, Drug, and Cosmetic Act (the act). … For a 12-month period, all costs are assumed to be incurred in the beginning of the second year. For a 24-month period, all costs are assumed to be incurred in the beginning of the third year.
72 FR 1455Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; MACROPLASTIQUE IMPLANTS
Federal Register · Notice · Feb 11, 2009
Submit electronic comments to http://www.regulations.gov . … Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
74 FR 6901Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 7, 2015
Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. … It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document.
80 FR 26273Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; HVAD ROTARY BLOOD PUMP
Federal Register · Notice · May 7, 2015
Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. … It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document.
80 FR 26275Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; DATSCAN
Federal Register · Notice · Apr 6, 2012
Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. … Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by October 3, 2012.
77 FR 20829Health and Human Services DepartmentFood and Drug AdministrationSurgeon's and Patient Examination Gloves; Reclassification; Extension of Comment Period
Federal Register · Proposed Rule · Oct 28, 1999
In response to the letters, FDA is extending the comment period for 90 additional days. … Received comments may be seen in the office above between 9 a.m. and 4 p.m., Monday through Friday. Dated: October 21, 1999. Margaret M. Dotzel, Acting Associate Commissioner for Policy.
64 FR 58004Health and Human Services DepartmentFood and Drug AdministrationFood Labeling; Guidelines for Voluntary Nutrition Labeling of Raw Fruits, Vegetables, and Fish
Federal Register · Rule · Jul 25, 2006
its 2005 reopening of the comment period document, each of which contained one or more comments. … New data also were submitted in response to the 2005 reopening of the comment period.
71 FR 42031Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 17, 2019
This notice solicits comments on electronic drug product reporting for human drug compounding outsourcing facilities under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act). … Furthermore, if a product was not compounded during a particular reporting period, no SPL response needs be sent for that product during that reporting period.
84 FR 34184Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; OVUGEL
Federal Register · Notice · May 7, 2015
Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. … It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document.
80 FR 26274Health and Human Services DepartmentFood and Drug AdministrationRevisions to the Requirements Applicable to Blood, Blood Components, and Source Plasma
Federal Register · Rule · Aug 19, 1999
If any significant adverse comment is received during the comment period, FDA will publish, within 30 days after the comment period ends, a document withdrawing the direct final rule. … If FDA receives no significant adverse comments during the specified comment period, FDA intends to publish a confirmation document within 30 days after the comment period ends confirming the effective
64 FR 45366Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 24, 2013
Comments Interested persons may submit either electronic comments regarding this document to http://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES … under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
78 FR 44573Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; VECTIBIX
Federal Register · Notice · May 12, 2008
Submit electronic comments to http://www.regulations.gov . … Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
73 FR 27000Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; AVASTIN
Federal Register · Notice · May 14, 2008
Submit electronic comments to http://www.regulations.gov . … Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
73 FR 27836Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Jun 23, 1997
FDA received approximately one dozen comments to the proposal and one requested that FDA extend the comment period for 14 days. … In order to ensure that all interested parties have a fair opportunity to comment, FDA is extending the comment period for 14 days.
62 FR 33783Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 27, 2004
The comment period closed on December 3, 2004. … Food, Drug, and Cosmetic Act (21 U.S.C. 350b(a)(2)).
69 FR 77258Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; Silvacote K
Federal Register · Notice · Sep 29, 1998
SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. … Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
63 FR 51939Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; Sucralose
Federal Register · Notice · Dec 21, 1998
SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. … Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
63 FR 70411Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 23, 2020
Restoration Act of 1988 (35 U.S.C. 156). … In enacting the Drug Price Competition and Patent Term Restoration Act of 1984 and the Generic Animal Drug and Patent Term Restoration Act of 1988, Congress sought to encourage development of new, safer
85 FR 3934Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Mar 17, 2014
30 days after the comment period on this direct final rule ends. … The comment period for this direct final rule runs concurrently with the comment period of the companion proposed rule.
79 FR 14609Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; VICTRELIS
Federal Register · Notice · Jun 27, 2014
Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. … It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document.
79 FR 36535Health 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.