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, 61451-61452 [05-21154]

Download as PDF Federal Register / Vol. 70, No. 204 / Monday, October 24, 2005 / Notices 3Notification 4Notification 61451 of donors determined not to be eligible for donation based on failure to satisfy eligibility criteria. of donors deferred based on reactive test results for evidence of infection due to communicable disease agents. TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1 No. of Recordkeepers 21 CFR Section Annual Frequency per Recordkeeping Total Annual Records Hours per Record Total Hours 606.100(b)2 2495 1 249 24 5,976 606.100(c) 2495 10 2,490 1 2,490 606.110(a)3 396 1 39 606.151(e) 2495 12 2,988 606.1604 2495 1,928 480,000 0.75 360,000 606.160(b)(1)(ix) 1,709 1,024 1,750,000 0.05 87,500 606.160(b)(1)(xi) 1,628 4 6,750 0.05 338 606.165 2495 1,928 480,000 606.170(a) 2495 12 2,988 1 610.40(g)(1) 1,628 1 1,628 0.5 0.5 0.083 0.083 Total 20 248 39,840 2,988 814 500,214 1There are no capital costs or operating and maintenance costs associated with this collection of information. recordkeeping requirements in §§ 640.3(a)(1), 640.4(a)(1), and 640.66, which address the maintenance of SOPs, are included in the estimate for § 606.100(b). 3The recordkeeping requirements in § 640.27(b), which address the maintenance of donor health records for the plateletpheresis, are included in the estimate for § 606.110(a). 4The recordkeeping requirements in §§ 640.3(a)(2) and (f); 640.4(a)(2); 640.25(b)(4) and (c)(1); 640.31(b); 640.33(b); 640.51(b); 640.53(b) and (c); 640.56(b) and (d); 640.61; 640.63(b)(3), (e)(1), and (e)(3); 640.65(b)(2); 640.71(b)(1); 640.72; and 640.76(a) and (b), which address the maintenance of various records are included in the estimate for § 606.160. 5Five percent of CMS transfusion services and FDA-registered blood establishments (0.05 X 4,980). 6Five percent of plateletpheresis and leukopheresis establishments (0.05 X 773). 2The Dated: October 17, 2005. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. 05–21153 Filed 10–21–05; 8:45 am] BILLING CODE 4160–01–S the Paperwork Reduction Act of 1995 (the PRA). Fax written comments on the collection of information by November 23, 2005. DATES: 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. ADDRESSES: 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: 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 15:19 Oct 21, 2005 Denver Presley, Office of Management Programs (HFA–250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–827–1472. 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: Notice. VerDate Aug<31>2005 FOR FURTHER INFORMATION CONTACT: Jkt 208001 PO 00000 Frm 00029 Fmt 4703 Sfmt 4703 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 E:\FR\FM\24OCN1.SGM 24OCN1 61452 Federal Register / Vol. 70, No. 204 / Monday, October 24, 2005 / Notices 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 POWDERS1 Annual Frequency per Responses No. of Respondents Same Formulation / Manufacturing Process Approach Same API / Solubility Approach Total Burden Hours 1There Total Annual Responses Hours per Response Total Hours 1 1 1 5 5 5 5 5 10 50 55 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 ARTICLES1 Annual Frequency per Responses No. of Respondents Same Formulation / Manufacturing Process Approach. Same API / Solubility Approach Total Burden Hours 1There Total Annual Responses Total Hours 2 2 2 5 10 10 10 10 20 200 210 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] information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. BILLING CODE 4160–01–S DATES: Fax written comments on the collection of information by November 23, 2005. DEPARTMENT OF HEALTH AND HUMAN SERVICES [Docket No. 2005N–0209] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Food Contact Substances Notification AGENCY: Food and Drug Administration, HHS. FOR FURTHER INFORMATION CONTACT: Notice. The Food and Drug Administration (FDA) is announcing that a proposed collection of SUMMARY: VerDate Aug<31>2005 15:19 Oct 21, 2005 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 comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: Fumie Yokota, Desk Officer for FDA, FAX: 202–395–6974. ADDRESSES: Food and Drug Administration ACTION: Hourse per Response Jkt 208001 Peggy Robbins, Office of Management Programs (HFA 250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–827–1223. PO 00000 Frm 00030 Fmt 4703 Sfmt 4703 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: Food Contact Substances Notification System—21 CFR 170.101 and 170.106— (OMB Control Number 0910–0495)— Extension Section 409(h) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 348(h)) establishes a premarket notification process for food contact substances. Section 409(h)(6) of the act defines a ‘‘food contact substance’’ as ‘‘any substance intended for use as a component of materials used in manufacturing, packing, packaging, transporting, or holding food if such use is not intended to have any technical effect in such food.’’ Section 409(h)(3) of the act requires that the notification process be used for authorizing the marketing of food contact substances E:\FR\FM\24OCN1.SGM 24OCN1

Agencies

[Federal Register Volume 70, Number 204 (Monday, October 24, 2005)]
[Notices]
[Pages 61451-61452]
From the Federal Register Online via the Government Printing 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
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