Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence Recommendations; Availability, 42800-42801 [2014-17293]

Download as PDF 42800 Federal Register / Vol. 79, No. 141 / Wednesday, July 23, 2014 / Notices Dated: July 18, 2014. Leslie Kux, Assistant Commissioner for Policy. DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [FR Doc. 2014–17294 Filed 7–22–14; 8:45 am] BILLING CODE 4164–01–P [Docket No. FDA–2007–D–0369] DEPARTMENT OF HEALTH AND HUMAN SERVICES Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence Recommendations; Availability Food and Drug Administration AGENCY: Food and Drug Administration, HHS. Notice. [Docket No. FDA–2013–N–1496] ACTION: Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Generic Food and Drug Administration Rapid Response Surveys 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, 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 productspecific 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 September 22, 2014. 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 See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance recommendations.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: Kris ´ Andre, Center for Drug Evaluation and AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing that a collection of information entitled ‘‘Generic FDA Rapid Response Surveys’’ 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 Colesville Rd., COLE–14526, Silver Spring, MD 20993–0002, PRAStaff@ fda.hhs.gov. FOR FURTHER INFORMATION CONTACT: On April 23, 2014, the Agency submitted a proposed collection of information entitled ‘‘Generic FDA Rapid Response Surveys’’ to OMB for review and clearance under 44 U.S.C. 3507. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has now approved the information collection and has assigned OMB control number 0910–0500. The approval expires on July 31, 2017. A copy of the supporting statement for this information collection is available on the Internet at https://www.reginfo.gov/ public/do/PRAMain. mstockstill on DSK4VPTVN1PROD with NOTICES SUPPLEMENTARY INFORMATION: Dated: July 18, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–17292 Filed 7–22–14; 8:45 am] BILLING CODE 4164–01–P VerDate Mar<15>2010 17:33 Jul 22, 2014 Jkt 232001 SUMMARY: PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, rm. 1615, Silver Spring, MD 20993–0002, 240–402–7959. SUPPLEMENTARY INFORMATION: I. Background 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 productspecific BE recommendations available to the public on FDA’s Web site at https://www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm. As described in that guidance, FDA 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 on April 2, 2014 (79 FR 18561). This notice announces draft product-specific recommendations, either new or revised, that are posted on FDA’s Web site. II. Drug Products for Which New Draft Product-Specific BE Recommendations Are Available FDA is announcing the availability of a new draft guidance for industry on product-specific BE recommendations for drug products containing the following active ingredients: TABLE 1—NEW DRAFT PRODUCT-SPECIFIC BE RECOMMENDATIONS FOR DRUG PRODUCTS A ........ C ........ E:\FR\FM\23JYN1.SGM Alogliptin benzoate. Alogliptin benzoate; Metformin hydrochloride (HCl). Alogliptin benzoate; Pioglitazone HCl. Amoxicillin (multiple reference listed drugs). Atenolol; Chlorthalidone. Canagliflozin. Carbidopa. Carbinoxamine maleate. 23JYN1 Federal Register / Vol. 79, No. 141 / Wednesday, July 23, 2014 / Notices TABLE 1—NEW DRAFT PRODUCT-SPE- www.regulations.gov and enter Docket CIFIC BE RECOMMENDATIONS FOR No. FDA–2007–D–0369. These draft and revised draft DRUG PRODUCTS—Continued D ........ E ........ F G H L ........ ........ ........ ........ M ....... O ........ P ........ R ........ S ........ T ........ Z ........ Cefixime. Colestipol HCl. Crizotinib. Daunorubicin citrate. Diflorasone diacetate. Dimethyl fumarate. Diphenhydramine HCl. Doxycycline (multiple reference listed drugs). Doxylamine succinate; Pyridoxine HCl. Esomeprazole strontium. Ethinyl estradiol; Levonorgestrel and Ethinyl estradiol. Ethinyl estradiol; Norethindrone acetate. Fosfomycin tromethamine. Gentamicin sulfate. Hydromorphone HCl. Lanreotide acetate. Linagliptin; Metformin HCl. Lomustine. Menthol; Methyl salicylate. Metformin HCl; Sitagliptin phosphate. Ospemifene. Oxcarbazepine. Paroxetine mesylate. Promethazine (multiple reference listed drugs and strengths). Propranolol HCl. Ropinirole HCl. Sucralfate (multiple reference listed drugs and dosage forms). Tacrolimus. Zolmitriptan. III. Drug Products for Which Revised Draft Product-Specific BE Recommendations Are Available FDA is announcing the availability of a revised draft guidance for industry on product-specific BE recommendations for drug products containing the following active ingredients: TABLE 2—REVISED DRAFT PRODUCTSPECIFIC BE RECOMMENDATIONS FOR DRUG PRODUCTS D ........ E ........ mstockstill on DSK4VPTVN1PROD with NOTICES F ........ H ........ I ......... L ........ M ....... N ........ P ........ Dronedarone HCl. Duloxetine HCl. Ergocalciferol Esomeprazole magnesium. Fluorouracil. Hydrochlorothiazide; Moexipril HCl. Imatinib mesylate. Lansoprazole. Mesalamine (multiple reference listed drugs). Nevirapine. Nilotinib HCl monohydrate. Pentosan polysulfate sodium. For a complete history of previously published Federal Register notices related to product-specific BE recommendations, please go to https:// VerDate Mar<15>2010 17:33 Jul 22, 2014 Jkt 232001 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 either electronic comments on any of the specific BE recommendations posted on FDA’s Web site to https:// www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). It is only necessary to send one set of comments. 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, and will be posted to the docket at https:// www.regulations.gov. 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. Dated: July 17, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–17293 Filed 7–22–14; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Availability of Interpretive Rule: Implementation of the Exclusion of Orphan Drugs for Certain Covered Entities Under the 340B Program Health Resources and Services Administration (HRSA), HHS. ACTION: Notice. AGENCY: HHS is announcing the availability of an interpretive rule providing HHS’s interpretation of section 340B(e) of the Public Health SUMMARY: PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 42801 Service Act (PHSA), entitled ‘‘Implementation of the Exclusion of Orphan Drugs for Certain Covered Entities Under the 340B Program.’’ The interpretive rule states that section 340B(e) of the PHSA excludes drugs with an orphan designation only when those drugs are transferred, prescribed, sold, or otherwise used for the rare condition or disease for which the drug was designated under section 526 of the Federal Food, Drug, and Cosmetic Act (FD&C Act). DATES: Effective July 23, 2014. ADDRESSES: Submit written requests for single copies of the interpretive rule to the Office of Pharmacy Affairs, Healthcare Systems Bureau, HRSA, 5600 Fishers Lane, Room 8W03A, Rockville, MD 20857. Send one selfaddressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the interpretive rule. FOR FURTHER INFORMATION CONTACT: CDR Krista Pedley, Director, Office of Pharmacy Affairs, Healthcare Systems Bureau, HRSA, 5600 Fishers Lane, Room 8W03A, Rockville, MD 20857, or by telephone at (301) 594–4353. SUPPLEMENTARY INFORMATION: I. Background HHS is announcing the availability of an interpretive rule entitled ‘‘Implementation of the Exclusion of Orphan Drugs for Certain Covered Entities Under the 340B Program.’’ This interpretive rule explains how HHS interprets section 340B(e) of the PHSA. 42 U.S.C. 256b(e). This interpretive rule intends to: (1) Provide clarity in the marketplace; (2) maintain the 340B Program savings for newly-eligible entities; and (3) protect the financial incentives for manufacturing orphan drugs designated for a rare disease or condition, as indicated in the Patient Protection and Affordable Care Act (‘‘Affordable Care Act’’) (Pub. L. 111– 148) and intended by Congress. Earlier this year, after notice and comment rulemaking, HHS issued a final rule on this subject, ‘‘Exclusion of Orphan Drugs for Certain Covered Entities Under 340B Program’’ (78 FR 44016, July 23, 2013) (the ‘‘Rule’’). The Rule was vacated by U.S. District Court for the District of Columbia on May 23, 2014, on the grounds that HHS does not have the authority to issue the Rule as a substantive rule. PhRMA v. HHS, No. 13–01501 (D.D.C. May 23, 2014). However, the decision did not invalidate HHS’s interpretation of the orphan drug exclusion in the Rule. E:\FR\FM\23JYN1.SGM 23JYN1

Agencies

[Federal Register Volume 79, Number 141 (Wednesday, July 23, 2014)]
[Notices]
[Pages 42800-42801]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-17293]


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

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, 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 September 22, 2014.

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: Kris Andr[eacute], Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 75, rm. 1615, Silver Spring, MD 20993-0002, 240-
402-7959.

SUPPLEMENTARY INFORMATION: 

I. Background

    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 at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.
    As described in that guidance, FDA 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 on 
April 2, 2014 (79 FR 18561). This notice announces draft product-
specific recommendations, either new or revised, that are posted on 
FDA's Web site.

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

    FDA is announcing the availability of a new draft guidance for 
industry on product-specific BE recommendations for drug products 
containing the following active ingredients:

Table 1--New Draft Product-Specific Be Recommendations for Drug Products
------------------------------------------------------------------------
 
------------------------------------------------------------------------
A............................  Alogliptin benzoate.
                               Alogliptin benzoate; Metformin
                                hydrochloride (HCl).
                               Alogliptin benzoate; Pioglitazone HCl.
                               Amoxicillin (multiple reference listed
                                drugs).
                               Atenolol; Chlorthalidone.
C............................  Canagliflozin.
                               Carbidopa.
                               Carbinoxamine maleate.

[[Page 42801]]

 
                               Cefixime.
                               Colestipol HCl.
                               Crizotinib.
D............................  Daunorubicin citrate.
                               Diflorasone diacetate.
                               Dimethyl fumarate.
                               Diphenhydramine HCl.
                               Doxycycline (multiple reference listed
                                drugs).
                               Doxylamine succinate; Pyridoxine HCl.
E............................  Esomeprazole strontium.
                               Ethinyl estradiol; Levonorgestrel and
                                Ethinyl estradiol.
                               Ethinyl estradiol; Norethindrone acetate.
F............................  Fosfomycin tromethamine.
G............................  Gentamicin sulfate.
H............................  Hydromorphone HCl.
L............................  Lanreotide acetate.
                               Linagliptin; Metformin HCl.
                               Lomustine.
M............................  Menthol; Methyl salicylate.
                               Metformin HCl; Sitagliptin phosphate.
O............................  Ospemifene.
                               Oxcarbazepine.
P............................  Paroxetine mesylate.
                               Promethazine (multiple reference listed
                                drugs and strengths).
                               Propranolol HCl.
R............................  Ropinirole HCl.
S............................  Sucralfate (multiple reference listed
                                drugs and dosage forms).
T............................  Tacrolimus.
Z............................  Zolmitriptan.
------------------------------------------------------------------------

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

    FDA is announcing the availability of a revised draft guidance for 
industry on product-specific BE recommendations for drug products 
containing the following active ingredients:

   Table 2--Revised Draft Product-Specific BE Recommendations for Drug
                                Products
------------------------------------------------------------------------
 
------------------------------------------------------------------------
D............................  Dronedarone HCl.
                               Duloxetine HCl.
E............................  Ergocalciferol
                               Esomeprazole magnesium.
F............................  Fluorouracil.
H............................  Hydrochlorothiazide; Moexipril HCl.
I............................  Imatinib mesylate.
L............................  Lansoprazole.
M............................  Mesalamine (multiple reference listed
                                drugs).
N............................  Nevirapine.
                               Nilotinib HCl monohydrate.
P............................  Pentosan polysulfate sodium.
------------------------------------------------------------------------

    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 No. 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 either electronic comments on any of 
the specific BE recommendations posted on FDA's Web site to https://www.regulations.gov or written comments to the Division of Dockets 
Management (see ADDRESSES). It is only necessary to send one set of 
comments. 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, and will be posted to the 
docket at https://www.regulations.gov.

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: July 17, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-17293 Filed 7-22-14; 8:45 am]
BILLING CODE 4164-01-P
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