[Federal Register Volume 70, Number 204 (Monday, October 24, 2005)]
[Notices]
[Pages 61451-61452]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-21154]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004D-0283]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Waivers 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 (the PRA).

DATES: Fax written comments on the collection of information by 
November 23, 2005.

ADDRESSES: OMB is still experiencing significant delays in the regular 
mail, including first class and express mail, and messenger deliveries 
are not being accepted. 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: Fumie 
Yokota, Desk Officer for FDA, FAX: 202-395-6974.

FOR FURTHER INFORMATION CONTACT: Denver Presley, Office of Management 
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-1472.

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.

Waivers of In Vivo Demonstration of Bioequivalence of Animal Drugs in 
Soluble Powder Oral Dosage Form Products and Type A Medicated Articles

    The generic Animal Drug and Patent Term Registration Act of 1988 
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 by the stature 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 or Type A medicated articles in either of two

[[Page 61452]]

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 
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), 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 two ways: ``USP definition'' approach 
or ``Dosage Adjusted'' approach.
    In the Federal Register of August 3, 2004 (69 FR 46553), the agency 
requested comments on this collection of information. In response to 
that notice, the agency received several comments on the guidance, two 
from individuals who were generally favorable and one from the Animal 
Health Institute (AHI), which was supportive of some aspects of the 
proposed guidance and not supportive of others. None of the comments 
received took issue with any aspect of the paperwork burden associated 
with the draft policy. The Center for Veterinary Medicine has revised 
the substance of the proposed guidance in several respects in response 
to AHI comments.
    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 data is records of generic drug 
applications over the past 10 years.

                                        Table 1.--Estimated Annual Reporting Burden for Water Soluble Powders\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                        Annual Frequency per      Total Annual
                                                   No. of Respondents         Responses             Responses        Hours per Response     Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Same Formulation / Manufacturing Process                             1                     1                     1                     5               5
 Approach
Same API / Solubility Approach                                       5                     5                     5                    10              50
Total Burden Hours                                ....................  ....................  ....................  ....................              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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                        Annual Frequency per      Total Annual
                                                   No. of Respondents         Responses             Responses        Hourse per Response    Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Same Formulation / Manufacturing Process                             2                     2                     2                     5              10
 Approach.
Same API / Solubility Approach                                      10                    10                    10                    20             200
Total Burden Hours                                ....................  ....................  ....................  ....................             210
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.


    Dated: October 17, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-21154 Filed 10-21-05; 8:45 am]
BILLING CODE 4160-01-S