Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Waiver of In Vivo Demonstration of Bioequivalence of Animal Drugs in Soluble Powder Oral Dosage Form Products and Type A Medicated Articles, 20229-20230 [2015-08635]

Download as PDF 20229 Federal Register / Vol. 80, No. 72 / Wednesday, April 15, 2015 / Notices In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. SUPPLEMENTARY INFORMATION: DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2008–N–0543] Agency Information Collection Activities; Submission for Office of Management and Budget Review; 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. The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of information by May 15, 2015. SUMMARY: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202–395–7285, or emailed to oira_ submission@omb.eop.gov. All comments should be identified with the OMB control number 0910–0575. Also include the FDA docket number found in brackets in the heading of this document. ADDRESSES: FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE–14526, Silver Spring, MD 20993–0002 PRAStaff@ fda.hhs.gov. FOR FURTHER INFORMATION CONTACT: 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 Number 0910–0575)—Extension The Center for Veterinary Medicine (CVM) issued guidance for industry (GFI) #171 entitled ‘‘Waivers of In Vivo Demonstration of Bioequivalence of Animal Drugs in Soluble Powder Oral Dosage Form Products and Type A Medicated Articles’’ to describe 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 (GADPTRA) of 1988 (Pub. L. 100–670) permitted generic animal drug manufacturers to copy those pioneer animal 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 follows in Tables 1 and 2 of this document. The source of the above data is records of generic drug applications over the past 10 years. In the Federal Register of January 12, 2015 (80 FR 1506), FDA published a 60day notice requesting public comment on the proposed collection of information. One comment was received, however it did not respond to any of the four information collection topics solicited and is therefore not addressed by the Agency. FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN FOR WATER SOLUBLE POWDERS 1 Number of responses per respondent Number of respondents CVM Guidance for industry #171 Average burden per response Total annual responses Total hours Same formulation/manufacturing process approach ........... Same API/solubility approach .............................................. 1 5 1 5 1 5 5 10 5 50 Total .............................................................................. ........................ ........................ ........................ ........................ 55 tkelley on DSK3SPTVN1PROD with NOTICES 1 There are no capital costs or operating and maintenance costs associated with this collection of information. TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN FOR TYPE A MEDICATED ARTICLES 1 Same formulation/manufacturing process approach ........... VerDate Sep<11>2014 17:29 Apr 14, 2015 Jkt 235001 PO 00000 Number of responses per respondent Number of respondents CVM Guidance for industry #171 Frm 00033 2 Fmt 4703 Sfmt 4703 Average burden per response Total annual responses 2 E:\FR\FM\15APN1.SGM 2 15APN1 Total hours 5 10 20230 Federal Register / Vol. 80, No. 72 / Wednesday, April 15, 2015 / Notices TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN FOR TYPE A MEDICATED ARTICLES 1—Continued Number of respondents CVM Guidance for industry #171 Number of responses per respondent Total annual responses Average burden per response Total hours 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: April 8, 2015. Leslie Kux, Associate Commissioner for Policy. has submitted the following proposed collection of information to OMB for review and clearance. [FR Doc. 2015–08635 Filed 4–14–15; 8:45 am] Food and Cosmetic Export Certificate Application Process (21 U.S.C. 381(e)) (OMB Control Number 0910–NEW) BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2014–N–2347] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food and Cosmetic Export Certificate Application Process AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of information by May 15, 2015. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202–395–7285, or emailed to oira_ submission@omb.eop.gov. All comments should be identified with the OMB control number 0910–NEW and title ‘‘Food and Cosmetic Export Certificate Application Process (21 U.S.C. 381(e)).’’ Also include the FDA 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 Road; COLE–14526, Silver Spring, MD 20993–0002 PRAStaff@ fda.hhs.gov. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA tkelley on DSK3SPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 17:29 Apr 14, 2015 Jkt 235001 Some foreign countries require manufacturers of FDA-regulated products to provide an export certificate for the products they wish to export to that country. A Certificate of Free Sale is a certificate (not pertaining to a particular production lot or export consignment) that indicates that the particular product is marketed in the United States or eligible for export, and that the particular manufacturer has no unresolved enforcement actions pending before or taken by FDA. FDA’s Center for Food Safety and Applied Nutrition (CFSAN) issues such certificates for food, food additives, seafood, dietary supplements, and cosmetics. Interested persons may request a certificate by using the electronic CFSAN Certificate Application Process, which is part of FDA Unified Registration and Listing System, or by submitting a paper Form FDA 3613d for cosmetic products or a paper Form FDA 3613e for food products. We use the information submitted to determine whether to issue the requested certificate. OMB has approved the submission of requests for export certificates on paper Forms FDA 3613d and FDA 3613e and, electronically, via the CFSAN Certificate Application Process under OMB control number 0910–0498. This notice announces that, to ensure the efficient review of the information collection by OMB under the PRA, we are seeking to obtain a new OMB Control Number for Forms FDA 3613d and FDA 3613e and the CFSAN Certificate Application Process to reflect that the electronic submission system for food and cosmetic export certificates is separate from the electronic submission system associated with export certificates for other FDA-regulated products approved under OMB control number 0910–0498. Upon OMB approval of this information collection request, we will adjust the burden hours associated with Forms PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 FDA 3613d and FDA 3613e and the CFSAN Certificate Application Process approved under OMB control number 0910–0498. We request the following information on Form FDA 3613d and the CFSAN Certificate Application Process, as currently approved by OMB: The name of and contact information for the requester; the name of and contact information for the exporting company (if different from requester); a designation of the type of certificate requested (‘‘general’’ or ‘‘productspecific’’); if product-specific, a list of the exact brand names of the products; the contact person, company name and address where the requested certificate should be sent; and, the name and account number (if applicable) of the requester’s preferred carrier for delivery of the certificate. Finally, Form FDA 3613d and the CFSAN Certificate Application Process requires the requester’s signature, the name and title of the person signing the form, as well as the date signed. We request the following information on Form FDA 3613e and the CFSAN Certificate Application Process, as currently approved by OMB: The name of and contact information for the manufacturer, as well as the manufacturer’s state license or registration number; the name of and contact information for the exporting company (if different from manufacturer), as well as the exporting company’s state license or registration number; a description of the shipment including the product, the common name, the manufacturer, and a description or additional comments; the name of the country to which the requester of the certificate intends to ship the product; the contact person, firm name and address where the requested certificate should be sent; and, the name and account number (if applicable) of the requester’s preferred carrier for delivery of the certificate. Form FDA 3613e and the CFSAN Certificate Application Process requires the requestor to submit an original or copy of the applicable product label or labels. Finally, Form FDA 3613e and the CFSAN Certificate Application Process E:\FR\FM\15APN1.SGM 15APN1

Agencies

[Federal Register Volume 80, Number 72 (Wednesday, April 15, 2015)]
[Notices]
[Pages 20229-20230]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-08635]

[[Page 20229]]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0543]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; 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 that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by May 15,
2015.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-0575.
Also include the FDA 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: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

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 Number 0910-0575)--
Extension

The Center for Veterinary Medicine (CVM) issued guidance for
industry (GFI) #171 entitled ``Waivers of In Vivo Demonstration of
Bioequivalence of Animal Drugs in Soluble Powder Oral Dosage Form
Products and Type A Medicated Articles'' to describe 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 (GADPTRA)
of 1988 (Pub. L. 100-670) permitted generic animal drug manufacturers
to copy those pioneer animal 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 follows in Tables 1 and 2 of this document. The source
of the above data is records of generic drug applications over the past
10 years.
In the Federal Register of January 12, 2015 (80 FR 1506), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. One comment was received, however it did not
respond to any of the four information collection topics solicited and
is therefore not addressed by the Agency.
FDA estimates the burden of this collection of information as
follows:

Table 1--Estimated Annual Reporting Burden for Water Soluble Powders \1\
----------------------------------------------------------------------------------------------------------------
Number of
CVM Guidance for industry #171 Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
Same formulation/manufacturing 1 1 1 5 5
process approach...............
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.

Table 2--Estimated Annual Reporting Burden for Type A Medicated Articles \1\
----------------------------------------------------------------------------------------------------------------
Number of
CVM Guidance for industry #171 Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
Same formulation/manufacturing 2 2 2 5 10
process approach...............

[[Page 20230]]

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: April 8, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-08635 Filed 4-14-15; 8:45 am]
BILLING CODE 4164-01-P

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