80 FR 20229 - 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 72 (April 15, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 72 (April 15, 2015)
| Page Range | 20229-20230 | |
| FR Document | 2015-08635 |
[Federal Register Volume 80, Number 72 (Wednesday, April 15, 2015)] [Notices] [Pages 20229-20230] From the Federal Register Online [www.thefederalregister.org] [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 [email protected]. 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 [email protected]. 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
![Federal Register / Vol. 80, No. 72 / Wednesday, April 15, 2015 / Notices 20229
DEPARTMENT OF HEALTH AND SUPPLEMENTARY INFORMATION: In clinical endpoint bioequivalence) may
HUMAN SERVICES compliance with 44 U.S.C. 3507, FDA be waived for soluble powder oral
has submitted the following proposed dosage form products or Type A
Food and Drug Administration collection of information to OMB for medicated articles in either of two
[Docket No. FDA–2008–N–0543] review and clearance. alternative ways. A biowaiver may be
Waiver of In Vivo Demonstration of granted if it can be shown that the
Agency Information Collection Bioequivalence of Animal Drugs in generic soluble powder oral dosage form
Activities; Submission for Office of Soluble Powder Oral Dosage Form product or Type A medicated article
Management and Budget Review; Products and Type A Medicated contains the same active and inactive
Comment Request; Waiver of In Vivo Articles—21 CFR 514.1(b)(7–8) (OMB ingredient(s) and is produced using the
Demonstration of Bioequivalence of Control Number 0910–0575)—Extension same manufacturing processes as the
Animal Drugs in Soluble Powder Oral approved comparator product or article.
Dosage Form Products and Type A The Center for Veterinary Medicine
Alternatively, a biowaiver may be
Medicated Articles (CVM) issued guidance for industry
(GFI) #171 entitled ‘‘Waivers of In Vivo granted without direct comparison to
AGENCY: Food and Drug Administration, Demonstration of Bioequivalence of the pioneer product’s formulation and
HHS. Animal Drugs in Soluble Powder Oral manufacturing process if it can be
Dosage Form Products and Type A shown that the active pharmaceutical
ACTION: Notice.
Medicated Articles’’ to describe the ingredient(s) (API) is the same as the
SUMMARY: The Food and Drug procedures that the Agency pioneer product, is soluble, and that
Administration (FDA) is announcing recommends for the review of requests there are no ingredients in the
that a proposed collection of for waiver of in vivo demonstration of formulation likely to cause adverse
information has been submitted to the bioequivalence for generic soluble pharmacologic effects. For the purpose
Office of Management and Budget powder oral dosage form products and of evaluating soluble powder oral
(OMB) for review and clearance under Type A medicated articles. dosage form products and Type A
the Paperwork Reduction Act of 1995. The Generic Animal Drug and Patent medicated articles, solubility can be
DATES: Fax written comments on the Term Registration Act (GADPTRA) of demonstrated in one of two ways: ‘‘USP
collection of information by May 15, 1988 (Pub. L. 100–670) permitted definition’’ approach or ‘‘Dosage
2015. generic animal drug manufacturers to adjusted’’ approach. The respondents
copy those pioneer animal drug for this collection of information are
ADDRESSES: To ensure that comments on products that were no longer subject to
the information collection are received, pharmaceutical companies
patent or other marketing exclusivity manufacturing animal drugs. FDA
OMB recommends that written protection. The approval for marketing
comments be faxed to the Office of estimates the burden for this collection
these generic products is based, in part, of information as follows in Tables 1
Information and Regulatory Affairs, upon a demonstration of bioequivalence
OMB, Attn: FDA Desk Officer, FAX: and 2 of this document. The source of
between the generic product and the above data is records of generic drug
202–395–7285, or emailed to oira_ pioneer product. This guidance clarifies
submission@omb.eop.gov. All applications over the past 10 years.
circumstances under which FDA
comments should be identified with the believes the demonstration of In the Federal Register of January 12,
OMB control number 0910–0575. Also bioequivalence required by the statute 2015 (80 FR 1506), FDA published a 60-
include the FDA docket number found does not need to be established on the day notice requesting public comment
in brackets in the heading of this basis of in vivo studies for soluble on the proposed collection of
document. powder oral dosage form products and information. One comment was
FOR FURTHER INFORMATION CONTACT: FDA Type A medicated articles. The data received, however it did not respond to
PRA Staff, Office of Operations, Food submitted in support of the waiver any of the four information collection
and Drug Administration, 8455 request are necessary to validate the topics solicited and is therefore not
Colesville Rd., COLE–14526, Silver waiver decision. The requirement to addressed by the Agency.
Spring, MD 20993–0002 PRAStaff@ establish bioequivalence through in vivo FDA estimates the burden of this
fda.hhs.gov. studies (blood level bioequivalence or collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN FOR WATER SOLUBLE POWDERS 1
Number of Average
Number of Total annual
CVM Guidance for industry #171 responses per burden per Total hours
respondents responses
respondent response
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.
TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN FOR TYPE A MEDICATED ARTICLES 1
tkelley on DSK3SPTVN1PROD with NOTICES
Number of Average
Number of Total annual
CVM Guidance for industry #171 responses per burden per Total hours
respondents responses
respondent response
Same formulation/manufacturing process approach ........... 2 2 2 5 10
VerDate Sep<11>2014 17:29 Apr 14, 2015 Jkt 235001 PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 E:\FR\FM\15APN1.SGM 15APN1](https://thefederalregister.org/doc/80_FR_20301/page/1.svg)
![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 Average
Number of Total annual
CVM Guidance for industry #171 responses per burden per Total hours
respondents responses
respondent response
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. has submitted the following proposed FDA 3613d and FDA 3613e and the
Leslie Kux, collection of information to OMB for CFSAN Certificate Application Process
Associate Commissioner for Policy. review and clearance. approved under OMB control number
[FR Doc. 2015–08635 Filed 4–14–15; 8:45 am] 0910–0498.
Food and Cosmetic Export Certificate
BILLING CODE 4164–01–P We request the following information
Application Process (21 U.S.C. 381(e))
on Form FDA 3613d and the CFSAN
(OMB Control Number 0910–NEW)
Certificate Application Process, as
DEPARTMENT OF HEALTH AND Some foreign countries require currently approved by OMB: The name
HUMAN SERVICES manufacturers of FDA-regulated of and contact information for the
products to provide an export certificate requester; the name of and contact
Food and Drug Administration for the products they wish to export to information for the exporting company
[Docket No. FDA–2014–N–2347] that country. A Certificate of Free Sale (if different from requester); a
is a certificate (not pertaining to a designation of the type of certificate
Agency Information Collection particular production lot or export requested (‘‘general’’ or ‘‘product-
Activities; Submission for Office of consignment) that indicates that the specific’’); if product-specific, a list of
Management and Budget Review; particular product is marketed in the the exact brand names of the products;
Comment Request; Food and United States or eligible for export, and the contact person, company name and
Cosmetic Export Certificate that the particular manufacturer has no address where the requested certificate
Application Process unresolved enforcement actions should be sent; and, the name and
pending before or taken by FDA. FDA’s account number (if applicable) of the
AGENCY: Food and Drug Administration, Center for Food Safety and Applied requester’s preferred carrier for delivery
HHS. Nutrition (CFSAN) issues such of the certificate. Finally, Form FDA
ACTION: Notice. certificates for food, food additives, 3613d and the CFSAN Certificate
SUMMARY: The Food and Drug seafood, dietary supplements, and Application Process requires the
Administration (FDA) is announcing cosmetics. Interested persons may requester’s signature, the name and title
that a proposed collection of request a certificate by using the of the person signing the form, as well
information has been submitted to the electronic CFSAN Certificate as the date signed.
Office of Management and Budget Application Process, which is part of We request the following information
(OMB) for review and clearance under FDA Unified Registration and Listing on Form FDA 3613e and the CFSAN
the Paperwork Reduction Act of 1995. System, or by submitting a paper Form Certificate Application Process, as
DATES: Fax written comments on the
FDA 3613d for cosmetic products or a currently approved by OMB: The name
collection of information by May 15, paper Form FDA 3613e for food of and contact information for the
2015. products. We use the information manufacturer, as well as the
submitted to determine whether to issue manufacturer’s state license or
ADDRESSES: To ensure that comments on the requested certificate. registration number; the name of and
the information collection are received, OMB has approved the submission of contact information for the exporting
OMB recommends that written requests for export certificates on paper company (if different from
comments be faxed to the Office of Forms FDA 3613d and FDA 3613e and, manufacturer), as well as the exporting
Information and Regulatory Affairs, electronically, via the CFSAN Certificate company’s state license or registration
OMB, Attn: FDA Desk Officer, FAX: Application Process under OMB control number; a description of the shipment
202–395–7285, or emailed to oira_ number 0910–0498. This notice including the product, the common
submission@omb.eop.gov. All announces that, to ensure the efficient name, the manufacturer, and a
comments should be identified with the review of the information collection by description or additional comments; the
OMB control number 0910–NEW and OMB under the PRA, we are seeking to name of the country to which the
title ‘‘Food and Cosmetic Export obtain a new OMB Control Number for requester of the certificate intends to
Certificate Application Process (21 Forms FDA 3613d and FDA 3613e and ship the product; the contact person,
U.S.C. 381(e)).’’ Also include the FDA the CFSAN Certificate Application firm name and address where the
docket number found in brackets in the Process to reflect that the electronic requested certificate should be sent;
heading of this document. submission system for food and and, the name and account number (if
FOR FURTHER INFORMATION CONTACT: FDA cosmetic export certificates is separate applicable) of the requester’s preferred
PRA Staff, Office of Operations, Food
tkelley on DSK3SPTVN1PROD with NOTICES
from the electronic submission system carrier for delivery of the certificate.
and Drug Administration, 8455 associated with export certificates for Form FDA 3613e and the CFSAN
Colesville Road; COLE–14526, Silver other FDA-regulated products approved Certificate Application Process requires
Spring, MD 20993–0002 PRAStaff@ under OMB control number 0910–0498. the requestor to submit an original or
fda.hhs.gov. Upon OMB approval of this information copy of the applicable product label or
SUPPLEMENTARY INFORMATION: In collection request, we will adjust the labels. Finally, Form FDA 3613e and the
compliance with 44 U.S.C. 3507, FDA burden hours associated with Forms CFSAN Certificate Application Process
VerDate Sep<11>2014 17:29 Apr 14, 2015 Jkt 235001 PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 E:\FR\FM\15APN1.SGM 15APN1](https://thefederalregister.org/doc/80_FR_20301/page/2.svg)
Document Created: 2015-12-18 11:13:10
Document Modified: 2015-12-18 11:13:10
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Fax written comments on the collection of information by May 15, 2015. | |
| Contact | FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002 [email protected] | |
| FR Citation | 80 FR 20229 |
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