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Federal Register · Notice · Jun 26, 2003
Background On October 26, 2002, MDUFMA (Public Law 107-250) amended the Federal Food, Drug, and Cosmetic Act (the act) by adding section 510(o) (21 U.S.C. 360(o)), which provided new regulatory requirements … Comments You may submit written or electronic comments on this notice to the Division of Dockets Management (see ADDRESSES ).
68 FR 38071Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 4, 2010
Background Section 204 of the Food and Drug Administration Modernization Act of 1997 (FDAMA) (Public Law 105-115) amended section 514 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360d … It is only necessary to send one set of comments. It is no longer necessary to sent two copies of mailed comments.
75 FR 61148Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Mar 14, 2011
Further, § 800.12 requires that packaged contact lens cleaning solutions contain a tamper-resistant feature, to prevent malicious adulteration. … Section 801.410(f) requires that the results of impact tests and description of the test method and apparatus be retained for a period of 3 years.
76 FR 13623Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Uncategorized Document · Jun 17, 1994
Interested persons were invited to submit comments by November 12, 1974. Reply comments in response to comments filed in the initial comment period could be submitted by December 12, 1974. … The hands were allowed to air dry for 3 minutes prior to a pretreatment sampling.
Proposed RuleHealth and Human Services DepartmentFederal Register · Notice · Jun 26, 2015
Background Section 226 of the Food and Drug Administration Amendments Act of 2007 and section 614 of the Food and Drug Administration Safety and Innovation Act amended the Federal Food, Drug, and Cosmetic … 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
80 FR 36821Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Nov 13, 1995
Additional bacteria may enter a bottle of water with exposure to the air. … All product water contact surfaces must be constructed of nontoxic and nonabsorbent material that can be adequately cleaned and sanitized and that is in compliance with section 409 of the act (21 U.S.C
60 FR 57076Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Apr 23, 2008
Further, § 800.12 requires that packaged contact lens cleaning solutions contain a tamper-resistant feature, to prevent malicious adulteration. … Section 801.410(f) requires that the results of impact tests and description of the test method and apparatus be retained for a period of 3 years.
73 FR 21959Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 27, 2008
Further, § 800.12 requires that packaged contact lens cleaning solutions contain a tamper-resistant feature, to prevent malicious adulteration. … Section 801.410(f) requires that the results of impact tests and description of the test method and apparatus be retained for a period of 3 years.
73 FR 36534Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Oct 19, 2018
(FD&C Act). … (vi) Air bolus testing must demonstrate that the device can withstand worst-case scenario air pressures.
83 FR 52964Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · May 29, 2003
Excretion via urine, feces, and expired air accounted for 95.1 percent of the administered dose in the 96-hour post-administration period. … The agency is also providing interested persons a period of 150 days to submit comments replying to comments regarding this advance notice of proposed rulemaking.
68 FR 32232Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Jul 11, 2022
FDA-2022-F-1108] Environmental Defense Fund, Maricel Maffini, Breast Cancer Prevention Partners, Clean Water Action/Clean Water Fund, Consumer Reports, Endocrine Society, Environmental Working Group, … Background Under section 409(b)(5) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 348(b)(5)), we are giving notice that we have filed a food additive petition (FAP 2B4831), submitted by Environmental
87 FR 41079Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Aug 15, 1996
In addition, titanium dioxide is being currently developed as a photooxidative self-cleaning and/or biocidal coating for industrial surfaces (Ref. 16). … Knowland to Gasparro's Comment,'' FEBS letters, 336:186, 1993. 33.
61 FR 42398Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Mar 6, 2006
Description : The Federal Food, Drug, and Cosmetic Act (the act) prohibits the distribution of adulterated food in interstate commerce (21 U.S.C. 331 and 342). … Sanitation activities include procedures for cleaning equipment, food-contact surfaces and plant facilities; chemical use and storage; cleaning equipment maintenance, use, and storage; pest control; and
71 FR 11209Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Jun 13, 2003
Comment Dates : Submit written comments by August 27, 2003. … The comment period for the direct final rule runs concurrently with that of the companion proposed rule.
68 FR 35290Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 25, 2010
The Federal Food, Drug, and Cosmetic Act (FD&C Act) prohibits the distribution of adulterated food in interstate commerce (21 U.S.C. 331 and 342). … Sanitation activities include procedures for cleaning equipment, food-contact surfaces, and plant facilities; chemical use and storage; cleaning equipment maintenance, use, and storage; pest control; and
75 FR 65491Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Apr 3, 2019
(FD&C Act) (21 U.S.C. 341, 343, and 371). … Mandates Reform Act of 1995 (Pub.
84 FR 12975Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Oct 5, 2021
—Pressure drop through air valve (mm H 2 O). —Air flow through air valve (cc/min). … —Air flow through air valve (cc/min). —Filter length (mm). —Filter pressure drop (mm H 2 O).
86 FR 55224Health and Human Services DepartmentFood and Drug AdministrationGastroenterology-Urology Devices; Classification for External Penile Rigidity Devices
Federal Register · Proposed Rule · Mar 17, 2004
The January 4, 1999, proposed rule provided an opportunity for interested persons to submit comments. The 90-day comment period ended on April 15, 1999. FDA received no comments. … Infection is also a potential risk as a result of injury or inadequate cleaning of the devices. F.
69 FR 12598Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Oct 28, 1997
Air kerma and kerma The Omnibus Trade and Competitiveness Act of 1988 amended the Metric Conversion Act of 1975 to require each Federal agency to use the International Systems of Units (SI) in its … (d) Air kerma means kerma in a given mass of air. The unit used to measure the quantity of air kerma is the Gray (Gy).
62 FR 55852Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Mar 3, 2021
Background Section 204 of the Food and Drug Administration Modernization Act of 1997 (Pub. L. 105-115) amended section 514 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360d). … Such standards are those that FDA has recognized by notice published in the Federal Register or that FDA has decided to recognize but for which recognition is pending (because a periodic notice has
86 FR 12476Health and Human Services DepartmentFood and Drug Administration
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