80 FR 7 pgs. 1506-1507 - Agency Information Collection Activities; Proposed Collection; Comment Request; Waiver of In Vivo Demonstration of Bioequivalence of Animal Drugs in Soluble Powder Oral Dosage Form Products and Type A Medicated Articles
Type: NOTICEVolume: 80Number: 7Pages: 1506 - 1507
Pages: 1506, 1507Docket number: [Docket No. FDA-2008-N-0543]
FR document: [FR Doc. 2015-00207 Filed 1-9-15; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0543]
Agency Information Collection Activities; Proposed Collection; Comment Request; Waiver of In Vivo Demonstration of Bioequivalence of Animal Drugs in Soluble Powder Oral Dosage Form Products and Type A Medicated Articles
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Notice.
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, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the current burden hours on regulated industry of complying with the guidance underlying this collection of information.
DATES:
Submit electronic or written comments on the collection of information by March 13, 2015.
ADDRESSES:
Submit electronic comments on the collection of information to http://www.regulations.gov . Submit written comments on the collection of information to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT:
FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, PRAStaff@fda.hhs.gov .
SUPPLEMENTARY INFORMATION:
Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. "Collection of information" is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal 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.
[top] 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.
Waiver of In Vivo Demonstration of Bioequivalence of Animal Drugs in Soluble Powder Oral Dosage Form Products and Type A Medicated Articles-21 CFR 514.1(b)(7-8) (OMB Control No. 0910-0575)-Extension
In the Federal Register of February 17, 2006 (79 FR 8596), FDA's Center for Veterinary Medicine issued a guidance entitled "Guidance for Industry # 171, Waivers of In Vivo Demonstration of Bioequivalence of Animal Drugs in Soluble Powder Oral Dosage Form Products and Type A Medicated Articles" to address a perceived need for Agency guidance in its work with the animal health industry. This guidance describes the procedures that the Agency recommends for the review of requests for waiver of in vivo demonstration of bioequivalence for generic soluble powder oral dosage form products and Type A medicated articles.
The Generic Animal Drug and Patent Term Registration Act of 1988 (Pub. L. 100-670) permitted generic drug manufacturers to copy those pioneer drug products that were no longer subject to patent or other marketing exclusivity protection. The approval for marketing these generic products is based, in part, upon a demonstration of bioequivalence between the generic product and pioneer product. This guidance clarifies circumstances under which FDA believes the demonstration of bioequivalence required by the statute does not need to be established on the basis of in vivo studies for soluble powder oral dosage form products and Type A medicated articles. The data submitted in support of the waiver request are necessary to validate the waiver decision. The requirement to establish bioequivalence through in vivo studies (blood level bioequivalence or clinical endpoint bioequivalence) may be waived for soluble powder oral dosage form products or Type A medicated articles in either of two alternative ways. A biowaiver may be granted if it can be shown that the generic soluble powder oral dosage form product or Type A medicated article contains the same active and inactive ingredient(s) and is produced using the same manufacturing processes as the approved comparator product or article. Alternatively, a biowaiver may be granted without direct comparison to the pioneer product's formulation and manufacturing process if it can be shown that the active pharmaceutical ingredient(s) (API) is the same as the pioneer product, is soluble, and that there are no ingredients in the formulation likely to cause adverse pharmacologic effects. For the purpose of evaluating soluble powder oral dosage form products and Type A medicated articles, solubility can be demonstrated in one of two ways: "USP definition" approach or "Dosage adjusted" approach. The respondents for this collection of information are pharmaceutical companies manufacturing animal drugs. FDA estimates the burden for this collection of information as shown in tables 1 and 2 of this document. The source of the data is records of generic drug applications over the past 10 years.
FDA estimates the burden of this collection of information as follows:
| No. of respondents | No. of responses per respondent | Total annual responses | Average burden per response | Total hours | |
|---|---|---|---|---|---|
| Same formulation/manufacturing process approach | 1 | 1 | 1 | 5 | 5 |
| Same API/solubility approach | 5 | 5 | 5 | 10 | 50 |
| Total | 55 | ||||
| 1 There are no capital costs or operating and maintenance costs associated with this collection of information. | |||||
| No. of respondents | No. of responses per respondent | Total annual responses | Average burden per response | Total hours | |
|---|---|---|---|---|---|
| Same formulation/manufacturing process approach | 2 | 2 | 2 | 5 | 10 |
| Same API/solubility approach | 10 | 10 | 10 | 20 | 200 |
| Total | 210 | ||||
| 1 There are no capital costs or operating and maintenance costs associated with this collection of information. | |||||
Dated: January 6, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-00207 Filed 1-9-15; 8:45 am]
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