21 CFR 310 - NEW DRUGS | LII / Legal Information Institute

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Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 360b-360f, 360j, 361(a), 371, 374, 375, 379e; 42 U.S.C. 216, 241, 242(a), 262, 263b-263n.

Title 21 published on 2011-04-01

The following are only the Rules published in the Federal Register after the published date of Title 21.

For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.

2011-06-17; vol. 76 # 117 - Friday, June 17, 2011

76 FR 35620 - Labeling and Effectiveness Testing; Sunscreen Drug Products for Over-the-Counter Human Use

GPO FDSys XML | Text

Additional Documents

type	regulations.gov
FR Doc.	2011-14766
RIN	0910-AF43
Docket No.	FDA-1978-N-0018

DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration

Final rule.

Effective Date: This final rule is effective June 18, 2012. For additional information concerning this effective date, see section X in the preamble of this document. The incorporation by reference of a certain publication listed in this rule is approved by the Director of the Federal Register as of June 18, 2012. Compliance Date: The compliance date for all products subject to this final rule with annual sales less than $25,000 is June 17, 2013. The compliance date for all other products subject to this final rule is June 18, 2012. Implementation date: FDA is lifting the delay of implementation date for § 201.66 as published at 69 FR 53801, September 3, 2004.

21 CFR Parts 201 and 310

Summary

The Food and Drug Administration (FDA) is issuing this document to address labeling and effectiveness testing for certain over-the counter (OTC) sunscreen products containing specified active ingredients and marketed without approved applications. This document addresses labeling and effectiveness testing issues raised by the nearly 2,900 submissions that we received in response to the sunscreen proposed rule of August 27, 2007 (2007 proposed rule). The document also identifies specific claims that render a product that is subject to this rule misbranded or would not be allowed on any OTC sunscreen product marketed without an approved application. The document does not address issues related to sunscreen active ingredients or certain other issues regarding the GRASE determination for sunscreen products. The document requires OTC sunscreen products to comply with the content and format requirements for OTC drug labeling contained in the 1999 Drug Facts final rule (published in the Federal Register of March 17, 1999, by lifting the delay of implementation date for that rule that we published on September 3, 2004).

76 FR 35665 - Draft Guidance for Industry on Enforcement Policy for Over-the-Counter Sunscreen Drug Products Marketed Without an Approved Application; Availability

GPO FDSys XML | Text

Additional Documents

type	regulations.gov
FR Doc.	2011-14767
RIN
Docket No.	FDA-2010-D-0509

DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration

Notice of availability.

Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers all comments on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by August 16, 2011. Submit written comments on the proposed collection of information by August 16, 2011.

21 CFR Parts 201 and 310

Summary

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled “Enforcement Policy—OTC Sunscreen Drug Products Marketed Without an Approved Application.” The draft guidance is intended to inform manufacturers of over-the-counter (OTC) sunscreen products about our enforcement policy for certain OTC sunscreen products marketed without an approved new drug application. The draft guidance describes our intended approach to enforcement for certain OTC sunscreen products prior to an effective final monograph.

This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.

This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].

It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.

United States Code

21 USC 353 - Exemptions and consideration for certain drugs, devices, and biological products

21 USC 360b - New animal drugs

21 USC 360c - Classification of devices intended for human use

21 USC 360d - Performance standards

21 USC 360e - Premarket approval

21 USC § 360e–1 - Pediatric uses of devices

21 USC 360f - Banned devices

21 USC 360j - General provisions respecting control of devices intended for human use

21 USC 361 - Adulterated cosmetics

21 USC 375 - Publicity

42 USC 216 - Regulations

42 USC 241 - Research and investigations generally

42 USC 242 - Studies and investigations on use and misuse of narcotic drugs and other drugs; annual report to Attorney General; cooperation with States

42 USC 263b - Certification of mammography facilities

42 USC § 259 to 261a - Repealed.

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR 310

2011-06-17; vol. 76 # 117 - Friday, June 17, 2011

76 FR 35620 - Labeling and Effectiveness Testing; Sunscreen Drug Products for Over-the-Counter Human Use

GPO FDSys XML | Text

Additional Documents

type	regulations.gov
FR Doc.	2011-14766
RIN	0910-AF43
Docket No.	FDA-1978-N-0018

DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration

Final rule.

Effective Date: This final rule is effective June 18, 2012. For additional information concerning this effective date, see section X in the preamble of this document. The incorporation by reference of a certain publication listed in this rule is approved by the Director of the Federal Register as of June 18, 2012. Compliance Date: The compliance date for all products subject to this final rule with annual sales less than $25,000 is June 17, 2013. The compliance date for all other products subject to this final rule is June 18, 2012. Implementation date: FDA is lifting the delay of implementation date for § 201.66 as published at 69 FR 53801, September 3, 2004.

21 CFR Parts 201 and 310

Summary

The Food and Drug Administration (FDA) is issuing this document to address labeling and effectiveness testing for certain over-the counter (OTC) sunscreen products containing specified active ingredients and marketed without approved applications. This document addresses labeling and effectiveness testing issues raised by the nearly 2,900 submissions that we received in response to the sunscreen proposed rule of August 27, 2007 (2007 proposed rule). The document also identifies specific claims that render a product that is subject to this rule misbranded or would not be allowed on any OTC sunscreen product marketed without an approved application. The document does not address issues related to sunscreen active ingredients or certain other issues regarding the GRASE determination for sunscreen products. The document requires OTC sunscreen products to comply with the content and format requirements for OTC drug labeling contained in the 1999 Drug Facts final rule (published in the Federal Register of March 17, 1999, by lifting the delay of implementation date for that rule that we published on September 3, 2004).

76 FR 35665 - Draft Guidance for Industry on Enforcement Policy for Over-the-Counter Sunscreen Drug Products Marketed Without an Approved Application; Availability

GPO FDSys XML | Text

Additional Documents

type	regulations.gov
FR Doc.	2011-14767
RIN
Docket No.	FDA-2010-D-0509

DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration

Notice of availability.

Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers all comments on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by August 16, 2011. Submit written comments on the proposed collection of information by August 16, 2011.

21 CFR Parts 201 and 310

Summary

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled “Enforcement Policy—OTC Sunscreen Drug Products Marketed Without an Approved Application.” The draft guidance is intended to inform manufacturers of over-the-counter (OTC) sunscreen products about our enforcement policy for certain OTC sunscreen products marketed without an approved new drug application. The draft guidance describes our intended approach to enforcement for certain OTC sunscreen products prior to an effective final monograph.

76 FR 35678 - SPF Labeling and Testing Requirements and Drug Facts Labeling for Over-the-Counter Sunscreen Drug Products; Agency Information Collection Activities; Proposed Collection

GPO FDSys XML | Text

Additional Documents

type	regulations.gov
FR Doc.	2011-14771
RIN
Docket No.	FDA-2011-N-0449

DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration

Comment request.

Submit either electronic or written comments on the collection of information by August 16, 2011.

21 CFR Parts 201 and 310

Summary

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. 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. This notice solicits comments on SPF labeling and testing requirements for over-the-counter (OTC) sunscreen products containing specified ingredients and marketed without approved applications, and on compliance with Drug Facts labeling requirements for all OTC sunscreen products.

2011-03-09; vol. 76 # 46 - Wednesday, March 9, 2011

76 FR 12916 - Benzocaine; Weight Control Drug Products for Over-the-Counter Human Use

GPO FDSys XML | Text

Additional Documents

type	regulations.gov
FR Doc.	2011-5145
RIN	0910-AF45
Docket No.	FDA-1981-N-0012

DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration

Proposed rule.

Submit written or electronic comments on the proposed rule by June 7, 2011. See section IX of this document for information on the proposed effective date of this proposed rule.

21 CFR Part 310

Summary

The Food and Drug Administration (FDA) is issuing a proposed rule to reclassify benzocaine from its previously proposed monograph status (category I) for over-the-counter (OTC) weight control use to nonmonograph status. Although, in the Federal Register of February 26, 1982, an advanced notice of proposed rulemaking (ANPR) included the recommendation of an Advisory Panel, consisting of health care providers from outside FDA, recommended that benzocaine should be generally recognized as safe and effective (GRASE) for weight control, this document includes our first evaluation of benzocaine for this use. Based on our evaluation of the available data and information, we have tentatively concluded that the data are not sufficient to support the safety and effectiveness of benzocaine for this use. This proposed rule, if finalized, would require an approved new drug application (NDA) or abbreviated new drug application (ANDA) for the marketing of OTC weight control products containing benzocaine.

2011-02-11; vol. 76 # 29 - Friday, February 11, 2011

76 FR 7743 - Professional Labeling for Laxative Drug Products for Over-the-Counter Human Use; Proposed Amendment to the Tentative Final Monograph

GPO FDSys XML | Text

Additional Documents

type	regulations.gov
FR Doc.	2011-3091
RIN	0910-AF38
Docket No.	FDA-1978-N-0021
Formerly Docket No.	78N-036L

DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration

Proposed rule.

Submit electronic or written comments by March 14, 2011. See section VI of this document for the effective date of any final rule that may publish based on this proposal.

21 CFR Parts 310 and 334

Summary

The Food and Drug Administration (FDA) is issuing a proposed rulemaking to amend the tentative final monograph (1985 TFM) for over-the-counter (OTC) laxative drug products (products that relieve occasional constipation). FDA is proposing that sodium phosphate salts (dibasic sodium phosphate, monobasic sodium phosphate, and the combination of dibasic sodium phosphate/monobasic sodium phosphate salts in a solution dosage form) are not generally recognized as safe (GRAS) for bowel cleansing. This document also would withdraw the professional labeling proposed for sodium phosphate salts in the 1985 TFM. Professional labeling is additional information about an OTC drug that is directed to healthcare professionals who prescribe, administer, or dispense medications and is not included in OTC drug product labeling for consumers. FDA is issuing this proposed rule after a careful review of new data and information on the serious side effects that have been associated with the customary dose of OTC sodium phosphates solution (approximately 60 grams (g) of sodium phosphates taken in two 45-milliliter (mL) doses 12 hours apart or approximately 50 g of sodium phosphates taken in a 45-mL dose followed by a 30-mL dose 12 hours later) for bowel cleansing prior to colonoscopy. This proposed rule is part of FDA's ongoing review of OTC drug products.

21 CFR 310 - NEW DRUGS

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