Agency Information Collection Activities; Proposed Collection; Comment Request; Waiver of In Vivo Demonstration of Bioequivalence of Animal Drugs in Soluble Powder Oral Dosage Form Products and Type A Medicated Articles, 1506-1507 [2015-00207]

Download as PDF 1506 Federal Register / Vol. 80, No. 7 / Monday, January 12, 2015 / Notices response rate of approximately 60 percent; thus, we will need to attempt to recruit 627 managers/establishments via telephone in order to meet our goal of 376 establishments. Each manager will respond to the recruiting script only once for approximately 3 minutes. Thus, the maximum burden for the manager recruiting attempts will be 31.35 hours (627 managers × 3 minutes). We will collect interview/survey data from a manager in each establishment. Each manager will respond only once for approximately 30 minutes. Thus, the maximum burden for the manager worker response rate of 90 percent (339 workers). Each worker will respond only once for approximately 10 minutes. Thus, the maximum burden for the worker interview/survey will be 56.5 hours (339 workers × 10 minutes). In total, the average burden per worker response will be 75.3 hours (18.8 hours for recruiting + 56.5 hours for the interview/survey). There is no cost to respondents other than their time. The total estimated annual burden for the data collection will be 295 hours. interview/survey will be 188 hours (376 managers × 30 minutes). In total, the average burden for managers will be 219.35 hours (31.35 hours for recruiting plus 188 hours for the interview/ survey). For each data collection, we will recruit a worker from each participating establishment to provide interview/ survey data. Each worker will respond to the recruiting script only once for approximately 3 minutes. Thus, the maximum burden for the worker recruiting attempts will be 18.8 hours (376 workers × 3 minutes). We expect a ESTIMATED ANNUALIZED BURDEN HOURS Type of respondents Retail Retail Retail Retail Number of respondents Form name managers ............ managers ............ food workers ........ food workers ........ Manager Telephone Recruiting Script ................. Manager Interview/survey ................................... Worker Recruiting Script ..................................... Worker Interview/survey ...................................... Total ........................ ......................................................................... Leroy A. Richardson, Chief, Information Collection Review Office, Office of Scientific Integrity, Office of the Associate Director for Science, Office of the Director, Centers for Disease Control and Prevention. [FR Doc. 2015–00241 Filed 1–9–15; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2008–N–0543] Agency Information Collection Activities; Proposed Collection; 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 an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for SUMMARY: tkelley on DSK3SPTVN1PROD with NOTICES Number of responses per respondent VerDate Sep<11>2014 17:35 Jan 09, 2015 Jkt 235001 627 376 376 339 Frm 00014 Fmt 4703 Sfmt 4703 3/60 30/60 3/60 10/60 Total burden hours 31 188 19 57 295 public comment in response to the notice. This notice solicits comments on the current burden hours on regulated industry of complying with the guidance underlying this collection of information. DATES: Submit electronic or written comments on the collection of information by March 13, 2015. ADDRESSES: Submit electronic comments on the collection of information to https:// www.regulations.gov. Submit written comments on the collection of information to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. All comments should be identified with the 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: Under 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(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or PO 00000 1 1 1 1 Average burden per response (in hours) provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing 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. E:\FR\FM\12JAN1.SGM 12JAN1 1507 Federal Register / Vol. 80, No. 7 / Monday, January 12, 2015 / Notices 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 No. 0910–0575)—Extension In the Federal Register of February 17, 2006 (79 FR 8596), FDA’s Center for Veterinary Medicine issued a guidance entitled ‘‘Guidance for Industry # 171, Waivers of In Vivo Demonstration of Bioequivalence of Animal Drugs in Soluble Powder Oral Dosage Form Products and Type A Medicated Articles’’ to address a perceived need for Agency guidance in its work with the animal health industry. This 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. The Generic Animal Drug and Patent Term Registration Act of 1988 (Pub. L. 100–670) 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 shown in tables 1 and 2 of this document. The source of the data is records of generic drug applications over the past 10 years. FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN FOR WATER SOLUBLE POWDERS 1 No. of responses per respondent No. of respondents 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 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 No. of respondents No. of responses per respondent Total annual responses Average burden per response Total hours Same formulation/manufacturing process approach ........... Same API/solubility approach .............................................. 2 10 2 10 2 10 5 20 10 200 Total .............................................................................. ........................ ........................ ........................ ........................ 210 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: January 6, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–00207 Filed 1–9–15; 8:45 am] Food and Drug Administration [Docket No. FDA–2009–N–0505] BILLING CODE 4164–01–P tkelley on DSK3SPTVN1PROD with NOTICES DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Reporting and Recordkeeping Requirements for Human Food and Cosmetics Manufactured From, Processed With, or Otherwise Containing, Material From Cattle AGENCY: Food and Drug Administration, HHS. VerDate Sep<11>2014 17:35 Jan 09, 2015 Jkt 235001 PO 00000 Frm 00015 Fmt 4703 Sfmt 4703 ACTION: Notice. The Food and Drug Administration (FDA) is announcing that a collection of information entitled ‘‘Reporting and Recordkeeping Requirements for Human Food and Cosmetics Manufactured From, Processed With, or Otherwise Containing, Material From Cattle’’ has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. SUMMARY: FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 FOR FURTHER INFORMATION CONTACT: E:\FR\FM\12JAN1.SGM 12JAN1

Agencies

[Federal Register Volume 80, Number 7 (Monday, January 12, 2015)]
[Notices]
[Pages 1506-1507]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-00207]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

Agency Information Collection Activities; Proposed Collection;
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 an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the current burden hours on
regulated industry of complying with the guidance underlying this
collection of information.

DATES: Submit electronic or written comments on the collection of
information by March 13, 2015.

ADDRESSES: Submit electronic comments on the collection of information
to https://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852. All comments should be identified with the 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: Under 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(c) 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. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing 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.

[[Page 1507]]

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 No. 0910-0575)--Extension

In the Federal Register of February 17, 2006 (79 FR 8596), FDA's
Center for Veterinary Medicine issued a guidance entitled ``Guidance
for Industry # 171, Waivers of In Vivo Demonstration of Bioequivalence
of Animal Drugs in Soluble Powder Oral Dosage Form Products and Type A
Medicated Articles'' to address a perceived need for Agency guidance in
its work with the animal health industry. This 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.
The Generic Animal Drug and Patent Term Registration Act of 1988
(Pub. L. 100-670) 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 shown in tables 1 and 2 of this document. The source of
the data is records of generic drug applications over the past 10
years.
FDA estimates the burden of this collection of information as
follows:

Table 1--Estimated Annual Reporting Burden for Water Soluble Powders \1\
----------------------------------------------------------------------------------------------------------------
No. of Average
No. of responses per Total annual burden per Total hours
respondents respondent responses 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\
----------------------------------------------------------------------------------------------------------------
No. of Average
No. of responses per Total annual burden per Total hours
respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
Same formulation/manufacturing 2 2 2 5 10
process approach...............
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: January 6, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-00207 Filed 1-9-15; 8:45 am]
BILLING CODE 4164-01-P

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.