Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Laxative Ingredient, 35917-35918 [E6-9896]

Download as PDF 35917 Federal Register / Vol. 71, No. 120 / Thursday, June 22, 2006 / Notices agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document. With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA’s functions, including whether the information will have practical utility; (2) the accuracy of FDA’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. Product Jurisdiction: Assignment of Agency Component for Review of Premarket Applications—21 CFR Part 3 (OMB Control Number 0910–0523)— Extension This regulation relates to agency management and organization and has two purposes. The first is to implement section 503(g) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353(g)), as added by the Safe Medical Devices Act of 1990 (Public Law 101–629), and amended by the Medical Device User Fee and Modernization Act of 2002 (Public Law 107–250), by specifying how FDA will determine the organizational component within FDA assigned to have primary jurisdiction for the premarket review and regulation of products that are comprised of any of the following combinations: (1) A drug and a device; (2) a device and a biological; (3) a biological and a drug; or (4) a drug, a device, and a biological. The second purpose of this regulation is to enhance the efficiency of agency management and operations by providing procedures for classifying and determining which agency component is designated to have primary jurisdiction for any drug, device, or biological product where such jurisdiction is unclear or in dispute. The regulation establishes a procedure by which an applicant may obtain an assignment or designation determination. The regulation requires that the request include the identity of the applicant, a comprehensive description of the product and its proposed use, and the applicant’s recommendation as to which agency component should have primary jurisdiction, with an accompanying statement of reasons. The information submitted would be used by FDA as the basis for making the assignment or designation decision. Most information required by the regulation is already required for premarket applications affecting drugs, devices, biologicals, and combination products. The respondents will be businesses or other for-profit organizations. FDA estimates the burden of this collection of information as follows: TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1 21 CFR Part 3 1There 43 BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006O–0232] Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Laxative Ingredient Food and Drug Administration, HHS. Notice of eligibility; request for data and information. ACTION: wwhite on PROD1PC61 with NOTICES Total Annual Responses 1 Hours per Response 43 24 Total Hours 1,032 are no capital costs or operating and maintenance costs associated with this collection of information. Dated: June 15, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6–9900 Filed 6–21–06; 8:45 am] AGENCY: Annual Frequency per Response No. of Respondents SUMMARY: The Food and Drug Administration (FDA) is announcing a call-for-data for safety and effectiveness information on the following condition as part of FDA’s ongoing review of overthe-counter (OTC) drug products: Sodium picosulfate, up to 10 milligrams VerDate Aug<31>2005 19:08 Jun 21, 2006 Jkt 208001 (mg), as a laxative single active ingredient. FDA reviewed a time and extent application (TEA) for this condition and determined that it is eligible for consideration in our OTC drug monograph system. FDA will evaluate the submitted data and information to determine whether this condition can be generally recognized as safe and effective (GRAS/E) for its proposed OTC use. DATES: Submit data, information, and comments by September 20, 2006. ADDRESSES: Submit comments, data, and information to the Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments, data, and information to https://www.fda.gov/ dockets/ecomments. FOR FURTHER INFORMATION CONTACT: Michael L. Koenig, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., WO Bldg. 22, Mail Stop 5411, Silver Spring, MD 20993, 301–796–2090. SUPPLEMENTARY INFORMATION: PO 00000 Frm 00058 Fmt 4703 Sfmt 4703 I. Background In the Federal Register of January 23, 2002 (67 FR 3060), FDA published a final rule establishing criteria and procedures for additional conditions to become eligible for consideration in the OTC drug monograph system. These criteria and procedures, codified in § 330.14 (21 CFR 330.14), permit OTC drugs initially marketed in the United States after the OTC drug review began in 1972 and OTC drugs without any marketing experience in the United States to become eligible for FDA’s OTC drug monograph system. The term ‘‘condition’’ means an active ingredient or botanical drug substance (or a combination of active ingredients or botanical drug substances), dosage form, dosage strength, or route of administration, marketed for a specific OTC use (§ 330.14 (a)). The criteria and procedures also permit conditions that are regulated as cosmetics or dietary supplements in foreign countries but that would be regulated as OTC drugs in the United States to become eligible for the OTC drug monograph system. E:\FR\FM\22JNN1.SGM 22JNN1 35918 Federal Register / Vol. 71, No. 120 / Thursday, June 22, 2006 / Notices Sponsors must provide specific data and information in a TEA to demonstrate that the condition has been marketed for a material time and to a material extent to become eligible for consideration in the OTC drug monograph system. When the condition is found eligible, FDA publishes a notice of eligibility and request for safety and effectiveness data for the proposed OTC use. The TEA that FDA reviewed (Ref. 1) and FDA’s evaluation of the TEA (Ref. 2) have been placed on public display in the Division of Dockets Management (see ADDRESSES) under the docket number found in brackets in the heading of this document. Information deemed confidential under 18 U.S.C. 1905, 5 U.S.C. 552(b), or 21 U.S.C. 331(j) was deleted from the TEA before it was placed on public display. wwhite on PROD1PC61 with NOTICES II. Request for Data and Information FDA determined that the information submitted in this TEA satisfies the criteria of § 330.14. FDA will evaluate sodium picosulfate, up to 10 mg, as a laxative single active ingredient for inclusion in the monograph for OTC laxative drug products (21 CFR part 334). Accordingly, FDA invites all interested persons to submit data and information, as described in § 330.14(f), on the safety and effectiveness of this active ingredient for this use so that FDA can determine whether it can be GRAS/E and not misbranded under recommended conditions of OTC use. The TEA does not include an official or proposed United States Pharmacopeia-National Formulary (USP–NF) drug monograph. According to § 330.14(i) sponsors must include, an official or proposed USP–NF monograph for this ingredient as part of the safety and effectiveness data for this ingredient. III. Comments Interested persons should submit comments, data, and information to the Division of Dockets Management (see ADDRESSES). Submit three copies of all comments, data, and information. Individuals submitting written information or anyone submitting electronic comments may submit one copy. Submissions are to be identified with the docket number found in brackets in the heading of this document and may be accompanied by supporting information. Received submissions may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Information submitted after the closing date will not be considered except by petition under (21 CFR 10.30). VerDate Aug<31>2005 19:08 Jun 21, 2006 Jkt 208001 IV. Marketing Policy Under § 330.14(h), any product containing the condition for which data and information are requested may not be marketed as an OTC drug in the United States at this time unless it is the subject of an approved new drug application or abbreviated new drug application. V. References The following references are on display in the Division of Dockets Management (see ADDRESSES) and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday. 1. TEA for sodium picosulfate submitted by Ropes and Gray LLP on behalf of Boehringer Ingelheim on June 24, 2005. 2. FDA’s evaluation and comments on the TEA for sodium picosulfate. Dated: June 16, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6–9896 Filed 6–21–06; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2004E–0444] Determination of Regulatory Review Period for Purposes of Patent Extension; BONIVA AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) has determined the regulatory review period for BONIVA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent that claims that human drug product. ADDRESSES: Submit written comments and petitions to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to https:// www.fda.gov/dockets/ecomments. FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory Policy (HFD–7), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–594–2041. SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term PO 00000 Frm 00059 Fmt 4703 Sfmt 4703 Restoration Act of 1984 (Public Law 98– 417) and the Generic Animal Drug and Patent Term Restoration Act (Public Law 100–670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product’s regulatory review period forms the basis for determining the amount of extension an applicant may receive. A regulatory review period consists of two periods of time: A testing phase and an approval phase. For human drug products, the testing phase begins when the exemption to permit the clinical investigations of the human drug application becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human drug product and continues until FDA grants permission to market the product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of Patents and Trademarks may award (for example, half the testing phase must be subtracted, as well as any time that may have occurred before the patent was issued), FDA’s determination of the length of a regulatory review period for a human drug product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B). FDA recently approved for marketing the human drug product BONIVA (ibandronate sodium). BONIVA is indicated for treatment and prevention of osteoporosis in postmenopausal women. Subsequent to this approval, the Patent and Trademark Office received a patent term restoration application for BONIVA (U.S. Patent No. 4,927,814) from Hoffmann-La Roche Inc., and the Patent and Trademark Office requested FDA’s assistance in determining this patent’s eligibility for patent term restoration. In a letter dated October 19, 2004, FDA advised the Patent and Trademark Office that this human drug product had undergone a regulatory review period and that the approval of BONIVA represented the first permitted commercial marketing or use of the product. Thereafter, the Patent and Trademark Office requested that FDA determine the product’s regulatory review period. FDA has determined that the applicable regulatory review period for BONIVA is 2,559 days. Of this time, 2,254 days occurred during the testing phase of the regulatory review period, E:\FR\FM\22JNN1.SGM 22JNN1

Agencies

[Federal Register Volume 71, Number 120 (Thursday, June 22, 2006)]
[Notices]
[Pages 35917-35918]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-9896]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006O-0232]


Over-the-Counter Drug Products; Safety and Efficacy Review; 
Additional Laxative Ingredient

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of eligibility; request for data and information.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing a call-
for-data for safety and effectiveness information on the following 
condition as part of FDA's ongoing review of over-the-counter (OTC) 
drug products: Sodium picosulfate, up to 10 milligrams (mg), as a 
laxative single active ingredient. FDA reviewed a time and extent 
application (TEA) for this condition and determined that it is eligible 
for consideration in our OTC drug monograph system. FDA will evaluate 
the submitted data and information to determine whether this condition 
can be generally recognized as safe and effective (GRAS/E) for its 
proposed OTC use.

DATES: Submit data, information, and comments by September 20, 2006.

ADDRESSES: Submit comments, data, and information to the Division of 
Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. 
Submit electronic comments, data, and information to https://
www.fda.gov/dockets/ecomments.

FOR FURTHER INFORMATION CONTACT: Michael L. Koenig, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., WO Bldg. 22, Mail Stop 5411, Silver Spring, MD 20993, 
301-796-2090.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of January 23, 2002 (67 FR 3060), FDA 
published a final rule establishing criteria and procedures for 
additional conditions to become eligible for consideration in the OTC 
drug monograph system. These criteria and procedures, codified in Sec.  
330.14 (21 CFR 330.14), permit OTC drugs initially marketed in the 
United States after the OTC drug review began in 1972 and OTC drugs 
without any marketing experience in the United States to become 
eligible for FDA's OTC drug monograph system. The term ``condition'' 
means an active ingredient or botanical drug substance (or a 
combination of active ingredients or botanical drug substances), dosage 
form, dosage strength, or route of administration, marketed for a 
specific OTC use (Sec.  330.14 (a)). The criteria and procedures also 
permit conditions that are regulated as cosmetics or dietary 
supplements in foreign countries but that would be regulated as OTC 
drugs in the United States to become eligible for the OTC drug 
monograph system.

[[Page 35918]]

    Sponsors must provide specific data and information in a TEA to 
demonstrate that the condition has been marketed for a material time 
and to a material extent to become eligible for consideration in the 
OTC drug monograph system. When the condition is found eligible, FDA 
publishes a notice of eligibility and request for safety and 
effectiveness data for the proposed OTC use. The TEA that FDA reviewed 
(Ref. 1) and FDA's evaluation of the TEA (Ref. 2) have been placed on 
public display in the Division of Dockets Management (see ADDRESSES) 
under the docket number found in brackets in the heading of this 
document. Information deemed confidential under 18 U.S.C. 1905, 5 
U.S.C. 552(b), or 21 U.S.C. 331(j) was deleted from the TEA before it 
was placed on public display.

II. Request for Data and Information

    FDA determined that the information submitted in this TEA satisfies 
the criteria of Sec.  330.14. FDA will evaluate sodium picosulfate, up 
to 10 mg, as a laxative single active ingredient for inclusion in the 
monograph for OTC laxative drug products (21 CFR part 334). 
Accordingly, FDA invites all interested persons to submit data and 
information, as described in Sec.  330.14(f), on the safety and 
effectiveness of this active ingredient for this use so that FDA can 
determine whether it can be GRAS/E and not misbranded under recommended 
conditions of OTC use.
    The TEA does not include an official or proposed United States 
Pharmacopeia-National Formulary (USP-NF) drug monograph. According to 
Sec.  330.14(i) sponsors must include, an official or proposed USP-NF 
monograph for this ingredient as part of the safety and effectiveness 
data for this ingredient.

III. Comments

    Interested persons should submit comments, data, and information to 
the Division of Dockets Management (see ADDRESSES). Submit three copies 
of all comments, data, and information. Individuals submitting written 
information or anyone submitting electronic comments may submit one 
copy. Submissions are to be identified with the docket number found in 
brackets in the heading of this document and may be accompanied by 
supporting information. Received submissions may be seen in the 
Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday. Information submitted after the closing date will not 
be considered except by petition under (21 CFR 10.30).

IV. Marketing Policy

    Under Sec.  330.14(h), any product containing the condition for 
which data and information are requested may not be marketed as an OTC 
drug in the United States at this time unless it is the subject of an 
approved new drug application or abbreviated new drug application.

V. References

    The following references are on display in the Division of Dockets 
Management (see ADDRESSES) and may be seen by interested persons 
between 9 a.m. and 4 p.m., Monday through Friday.

    1. TEA for sodium picosulfate submitted by Ropes and Gray LLP on 
behalf of Boehringer Ingelheim on June 24, 2005.
    2. FDA's evaluation and comments on the TEA for sodium 
picosulfate.

    Dated: June 16, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-9896 Filed 6-21-06; 8:45 am]
BILLING CODE 4160-01-S

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