Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence Recommendations; Availability, 35688-35689 [2012-14477]

Download as PDF 35688 Federal Register / Vol. 77, No. 115 / Thursday, June 14, 2012 / Notices TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1—Continued Number of respondents Number of disclosures per respondent 2 Total annual disclosures Average burden per disclosure ........................ ........................ ........................ ........................ Activity Total .............................................................................. Total hours 5,560 1 There pmangrum on DSK3VPTVN1PROD with NOTICES are no capital costs or operating and maintenance costs associated with this collection of information. 2 Number has been rounded to the nearest tenth. The labeling requirements of section 403(y) of the FD&C Act became effective on December 22, 2007, although FDA exercised enforcement discretion until September 30, 2010, to enable all firms to meet the labeling requirements for dietary supplements. FDA estimates that all labels required to include the domestic address or telephone number pursuant to section 403(y) of the FD&C Act have been revised by the effective date. Thus, in succeeding years, the Agency estimates that the burden hours associated with the labeling requirements of section 403(y) of the FD&C Act and the Agency’s recommendations on the use of an explanatory statement will apply only to new product labels. Based on the A.C. Nielsen Sales Scanner Data, FDA estimated that the number of dietary supplement SKUs for which sales of the products are greater than zero is 55,600. Assuming that the flow of new products is 10 percent per year, then approximately 5,560 new dietary supplement products will come on the market each year. FDA also estimates that there are about 1,460 dietary supplement manufacturers, repackagers, re-labelers, and holders of dietary supplements. Assuming the approximately 5,560 new products are split equally among the firms, then each firm would prepare labels for close to four new products per year (5,560 new products/1,460 firms is approximately 3.8 labels per firm). Thus, the estimated total annual disclosures are 5,560 (1,460 firms × 3.8 labels per year = 5,560). The Agency expects that firms prepare the required labeling for their products in a manner that takes into account at one time all information required to be disclosed on their product labels. Based upon its knowledge of food and dietary supplement labeling, FDA estimates that firms would require less than 0.5 hour per product to comply with the requirement to include the domestic address or telephone number pursuant to section 403(y) of the FD&C Act. The total hour burden of this task is shown in row 1 of table 1. FDA estimates that all firms will include an explanatory statement on the VerDate Mar<15>2010 14:34 Jun 13, 2012 Jkt 226001 label, which lets consumers know the purpose of the domestic address or telephone number on the label of the dietary supplement product. Based upon its knowledge of food and dietary supplement labeling, FDA estimates that firms would require less than 0.5 hour per product to comply with the Agency’s recommendations on the use of an explanatory statement. The total hour burden of this task is shown in row 2 of table 1. The total reporting hour burden is 5,560 hours, which equals the burden for the required domestic address or telephone (2,780) plus the burden for the explanatory statement before the domestic address or telephone number (2,780). Dated: June 8, 2012. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2012–14487 Filed 6–13–12; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2007–D–0369] Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence Recommendations; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of additional draft and revised draft product-specific bioequivalence (BE) recommendations. The recommendations provide productspecific guidance on the design of BE studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010 (75 FR 33311), FDA announced the availability of a guidance for industry entitled ‘‘Bioequivalence Recommendations for Specific Products,’’ which explained the process that would be used to make product-specific BE recommendations SUMMARY: PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 available to the public on FDA’s Web site. The BE recommendations identified in this notice were developed using the process described in that guidance. DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comments on these draft and revised draft guidances before it begins work on the final versions of the guidances, submit either electronic or written comments on the draft and revised draft product-specific BE recommendations listed in this notice by August 13, 2012. ADDRESSES: Submit written requests for single copies of the individual BE guidances to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993–0002. Send one selfaddressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance recommendations. Submit electronic comments on the draft product-specific BE recommendations to https:// www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: K. Geoffrey Wu, Center for Drug Evaluation and Research (HFD–600), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240–276–9326. SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry entitled ‘‘Bioequivalence Recommendations for Specific Products,’’ which explained the process that would be used to make product-specific BE recommendations available to the public on FDA’s Web site at https://www.fda.gov/Drugs/ GuidanceComplianceRegulatory Information/Guidances/default.htm. As described in that guidance, FDA E:\FR\FM\14JNN1.SGM 14JNN1 Federal Register / Vol. 77, No. 115 / Thursday, June 14, 2012 / Notices adopted this process as a means to develop and disseminate productspecific BE recommendations and provide a meaningful opportunity for the public to consider and comment on those recommendations. Under that process, draft recommendations are posted on FDA’s Web site and announced periodically in the Federal Register. The public is encouraged to submit comments on those recommendations within 60 days of their announcement in the Federal Register. FDA considers any comments received and either publishes final recommendations or publishes revised draft recommendations for comment. Recommendations were last announced in the Federal Register of March 28, 2012 (77 FR 18827). This notice announces draft product-specific recommendations, either new or revised, that are being posted on FDA’s Web site concurrently with publication of this notice. pmangrum on DSK3VPTVN1PROD with NOTICES II. Drug Products for Which New Draft Product-Specific BE Recommendations Are Available FDA is announcing new draft product-specific BE recommendations for drug products containing the following active ingredients: A Aliskiren hemifumarate; amlodipine besylate Alvimopan Azilsartan medoxomil B Bacitracin Boceprevir C Cefpodoxime proxetil (multiple reference listed drugs (RLDs)) Cefprozil (multiple RLDs) Cetirizine HCl Ciprofloxacin HCl; hydrocortisone Clomiphene citrate D Dabigatran etexilate mesylate Dexamethasone; tobramycin Dinoprostone Diphenhydramine; ibuprofen E Erythromycin F Famotidine; ibuprofen G Gabapentin enacarbil I Itraconazole K Ketoconazole L Lacosamide M Malathion Morphine sulfate; naltrexone HCl P VerDate Mar<15>2010 14:34 Jun 13, 2012 Jkt 226001 35689 Dated: June 8, 2012. Leslie Kux, Assistant Commissioner for Policy. Podofilox R Rotigotine Rufinamide [FR Doc. 2012–14477 Filed 6–13–12; 8:45 am] T Tapentadol HCl Tetrabenazine BILLING CODE 4160–01–P Zolpidem tartrate DEPARTMENT OF HEALTH AND HUMAN SERVICES Z III. Drug Products for Which Revised Draft Product-Specific BE Recommendations Are Available FDA is announcing revised draft product-specific BE recommendations for drug products containing the following active ingredients: D Dexamethasone; tobramycin (multiple RLDs) E Everolimus L Loteprednol etabonate Loteprednol etabonate; tobramycin S Sorafenib tosylate For a complete history of previously published Federal Register notices related to product-specific BE recommendations, please go to https:// www.regulations.gov and enter docket number FDA–2007–D–0369. These draft and revised draft guidances are being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). These guidances represent the Agency’s current thinking on product-specific design of BE studies to support ANDAs. They do not create or confer any rights for or on any person and do not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations. IV. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES) either electronic or written comments on any of the specific BE recommendations posted on FDA’s Web site. Identify comments with the docket number found in brackets in the heading of this document. The guidances, notices, and received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Food and Drug Administration [Docket No. FDA–2010–D–0146] Guidance for Industry on Irritable Bowel Syndrome—Clinical Evaluation of Drugs for Treatment; Availability; Correction AGENCY: Food and Drug Administration, HHS. ACTION: Notice; correction. The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of May 31, 2012 (77 FR 32124). The document announced the availability of a guidance for industry entitled ‘‘Irritable Bowel Syndrome— Clinical Evaluation of Drugs for Treatment.’’ The document was published with an incorrect docket number. This document corrects that error. SUMMARY: FOR FURTHER INFORMATION CONTACT: Joyce Strong, Office of Policy and Planning, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 3208, Silver Spring, MD 20993–0002, 301–796–9148. In FR Doc. 2012–13143, appearing on page 32124 in the Federal Register of Thursday, May 31, 2012, the following correction is made: 1. On page 32124, in the first column, in the headings section of the document, ‘‘[Docket No. FDA–2012–D–0146]’’ is corrected to read ‘‘[Docket No. FDA– 2010–D–0146]’’. SUPPLEMENTARY INFORMATION: Dated: June 8, 2012. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2012–14485 Filed 6–13–12; 8:45 am] BILLING CODE 4160–01–P V. Electronic Access Persons with access to the Internet may obtain the document at either https://www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm or https:// www.regulations.gov. PO 00000 Frm 00033 Fmt 4703 Sfmt 9990 E:\FR\FM\14JNN1.SGM 14JNN1

Agencies

[Federal Register Volume 77, Number 115 (Thursday, June 14, 2012)]
[Notices]
[Pages 35688-35689]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-14477]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-D-0369]


Draft and Revised Draft Guidances for Industry Describing 
Product-Specific Bioequivalence Recommendations; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of additional draft and revised draft product-specific 
bioequivalence (BE) recommendations. The recommendations provide 
product-specific guidance on the design of BE studies to support 
abbreviated new drug applications (ANDAs). In the Federal Register of 
June 11, 2010 (75 FR 33311), FDA announced the availability of a 
guidance for industry entitled ``Bioequivalence Recommendations for 
Specific Products,'' which explained the process that would be used to 
make product-specific BE recommendations available to the public on 
FDA's Web site. The BE recommendations identified in this notice were 
developed using the process described in that guidance.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comments on 
these draft and revised draft guidances before it begins work on the 
final versions of the guidances, submit either electronic or written 
comments on the draft and revised draft product-specific BE 
recommendations listed in this notice by August 13, 2012.

ADDRESSES: Submit written requests for single copies of the individual 
BE guidances to the Division of Drug Information, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993-0002. Send 
one self-addressed adhesive label to assist that office in processing 
your requests. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the draft guidance recommendations.
    Submit electronic comments on the draft product-specific BE 
recommendations to https://www.regulations.gov. Submit written comments 
to the Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: K. Geoffrey Wu, Center for Drug 
Evaluation and Research (HFD-600), Food and Drug Administration, 7519 
Standish Pl., Rockville, MD 20855, 240-276-9326.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of June 11, 2010, FDA announced the 
availability of a guidance for industry entitled ``Bioequivalence 
Recommendations for Specific Products,'' which explained the process 
that would be used to make product-specific BE recommendations 
available to the public on FDA's Web site at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm. As 
described in that guidance, FDA

[[Page 35689]]

adopted this process as a means to develop and disseminate product-
specific BE recommendations and provide a meaningful opportunity for 
the public to consider and comment on those recommendations. Under that 
process, draft recommendations are posted on FDA's Web site and 
announced periodically in the Federal Register. The public is 
encouraged to submit comments on those recommendations within 60 days 
of their announcement in the Federal Register. FDA considers any 
comments received and either publishes final recommendations or 
publishes revised draft recommendations for comment. Recommendations 
were last announced in the Federal Register of March 28, 2012 (77 FR 
18827). This notice announces draft product-specific recommendations, 
either new or revised, that are being posted on FDA's Web site 
concurrently with publication of this notice.

II. Drug Products for Which New Draft Product-Specific BE 
Recommendations Are Available

    FDA is announcing new draft product-specific BE recommendations for 
drug products containing the following active ingredients:

A
    Aliskiren hemifumarate; amlodipine besylate
    Alvimopan
    Azilsartan medoxomil
B
    Bacitracin
    Boceprevir
C
    Cefpodoxime proxetil (multiple reference listed drugs (RLDs))
    Cefprozil (multiple RLDs)
    Cetirizine HCl
    Ciprofloxacin HCl; hydrocortisone
    Clomiphene citrate
D
    Dabigatran etexilate mesylate
    Dexamethasone; tobramycin
    Dinoprostone
    Diphenhydramine; ibuprofen
E
    Erythromycin
F
    Famotidine; ibuprofen
G
    Gabapentin enacarbil
I
    Itraconazole
K
    Ketoconazole
L
    Lacosamide
M
    Malathion
    Morphine sulfate; naltrexone HCl
P
    Podofilox
R
    Rotigotine
    Rufinamide
T
    Tapentadol HCl
    Tetrabenazine
Z
    Zolpidem tartrate

III. Drug Products for Which Revised Draft Product-Specific BE 
Recommendations Are Available

    FDA is announcing revised draft product-specific BE recommendations 
for drug products containing the following active ingredients:

D
    Dexamethasone; tobramycin (multiple RLDs)
E
    Everolimus
L
    Loteprednol etabonate
    Loteprednol etabonate; tobramycin
S
    Sorafenib tosylate
    For a complete history of previously published Federal Register 
notices related to product-specific BE recommendations, please go to 
https://www.regulations.gov and enter docket number FDA-2007-D-0369.
    These draft and revised draft guidances are being issued consistent 
with FDA's good guidance practices regulation (21 CFR 10.115). These 
guidances represent the Agency's current thinking on product-specific 
design of BE studies to support ANDAs. They do not create or confer any 
rights for or on any person and do not operate to bind FDA or the 
public. An alternative approach may be used if such approach satisfies 
the requirements of the applicable statutes and regulations.

IV. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments on any of the 
specific BE recommendations posted on FDA's Web site. Identify comments 
with the docket number found in brackets in the heading of this 
document. The guidances, notices, and received comments may be seen in 
the Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.

V. Electronic Access

    Persons with access to the Internet may obtain the document at 
either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov.

    Dated: June 8, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-14477 Filed 6-13-12; 8:45 am]
BILLING CODE 4160-01-P
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