[Federal Register Volume 69, Number 148 (Tuesday, August 3, 2004)]
[Notices]
[Pages 46553-46555]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-17627]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004D-0283]


Draft Guidance for Industry: Waivers of In Vivo Demonstration of 
Bioequivalence of Animal Drugs in Soluble Powder Oral Dosage Form 
Products and Type A Medicated Articles; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance for industry (171) entitled 
``Waivers of In Vivo Demonstration of Bioequivalence of Animal Drugs in 
Soluble Powder Oral Dosage Form Products and Type A Medicated 
Articles.'' This draft guidance describes the procedures that the 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.

DATES:  Submit written or electronic comments on the draft guidance by 
October 18, 2004, to ensure their adequate consideration in preparation 
of the final document. General comments on agency guidance documents 
are welcome at any time. Written comments on the information collection 
provisions must be received by October 4, 2004.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Communications Staff (HFV-12), Center for Veterinary 
Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, 
MD 20855. Send one self-addressed adhesive label to assist that office 
in processing your requests. See the SUPPLEMENTARY INFORMATION section 
for electronic access to the guidance document.
    Submit written comments on the draft guidance and collection of 
information to the Division of Dockets Management (HFA-305), Food and 
Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. 
Submit electronic comments on the draft guidance and collection of 
information to http://www.fda.gov/dockets/ecomments. Comments should be 
identified with the full title of the draft guidance and the docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:
    Technical issues: Marilyn Martinez, Center for Veterinary Medicine 
(HFV- 130), Food and Drug Administration, 7500 Standish Pl., Rockville, 
MD 20855, 301-827-7577, e-mail: [email protected].
    Administrative issues: Lonnie Luther, Center for Veterinary 
Medicine (HFV-104), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-827-8549, e-mail: [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    The Center for Veterinary Medicine (CVM) has written this guidance 
to address a perceived need for agency guidance in its work with the 
animal health industry. This draft 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. As CVM develops 
policies on waivers involving other categories of animal drugs, it will 
issue additional guidance.

II. Paperwork Reduction Act of 1995

    Under the Paperwork Reduction Act of 1995 (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 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.

[[Page 46554]]

3506(c)(2)(A)) requires Federal agencies to provide a 60-day notice in 
the Federal Register concerning each proposed collection of information 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing a 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.
    Title: Waivers of In Vivo Demonstration of Bioequivalence of Animal 
Drugs in Soluble Powder Oral Dosage Form Products and Type A Medicated 
Articles
    Description: The Generic Animal Drug and Patent Term Registration 
Act (GADPTRA) 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 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.

                                        Table 1.--Estimated Annual Reporting Burden for Water Soluble Powders\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                  Annual Frequency  of      Total Annual
                                             No. of Respondents         Responses             Responses        Hours per Response        Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Same formulation/manufacturing                       1                     1                     1                     5                     5
process 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  of      Total Annual
                                             No. of Respondents         Responses             Responses        Hours per Response        Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Same formulation/manufacturing                       2                     2                     2                     5                    10
process approach
--------------------------------------------------------------------------------------------------------------------------------------------------------
Same API/solubility approach                        10                    10                    10                    20                   200
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 46555]]

 
Total Burden Hours                          ....................  ....................  ....................  ....................         210
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

III. Significance of Guidance

    This draft level 1 guidance is being issued consistent with FDA's 
good guidance practices regulation (21 CFR 10.115). This draft 
guidance, when finalized, will represent the agency's current thinking 
on the topic. It does not create or confer any rights for or on any 
person and does not operate to bind FDA or the public. An alternate 
method may be used as long as it satisfies the requirements of 
applicable statutes and regulations.

IV. Comments

    This draft guidance is being distributed for comment purposes only 
and is not intended for implementation at this time. Interested persons 
may submit written or electronic comments to the Division of Dockets 
Management (see ADDRESSES) regarding this draft guidance document. Two 
paper copies of any comments are to be submitted, except that 
individuals may submit one paper copy. Comments should be identified 
with the docket number found in brackets in the heading of this 
document. A copy of the document and received comments are available 
for public examination in the Division of Dockets Management between 9 
a.m. and 4 p.m., Monday through Friday.

V. Electronic Access

    Copies of the draft guidance document entitled ``Waivers of In Vivo 
Demonstration of Bioequivalence of Certain Animal Drugs in Soluble 
Powder Oral Dosage Form Products and Type A Medicated Articles'' may be 
obtained from the CVM home page at http://www.fda.gov/cvm and from the 
Division of Dockets Management Web site http://www.fda.gov/ohrms/dockets/default.htm.

    Dated: July 27, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-17627 Filed 8-2-04; 8:45 am]
BILLING CODE 4160-01-S