80 FR 37273 - Product-Specific Bioequivalence Recommendations; Draft and Revised Draft Guidances for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 125 (June 30, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 125 (June 30, 2015)
| Page Range | 37273-37275 | |
| FR Document | 2015-16013 |
[Federal Register Volume 80, Number 125 (Tuesday, June 30, 2015)] [Notices] [Pages 37273-37275] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-16013] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2007-D-0369] Product-Specific Bioequivalence Recommendations; Draft and Revised Draft Guidances for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) 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'' that 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 31, 2015. 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, 10001 New Hampshire Ave., Hillandale Bldg., 4th Floor, 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 http://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: Xiaoqiu Tang, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 4730, Silver Spring, MD 20993-0002, 301- 796-5850. 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'' that explained the process that would be used to make product-specific BE recommendations available to the public on FDA's Web site at http://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 March 9, 2015 (80 FR 12502). This notice announces draft product- specific [[Page 37274]] 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 ------------------------------------------------------------------------ ------------------------------------------------------------------------- Abacavir sulfate; Dolutegravir sodium; Lamivudine. Afatinib dimaleate. Alendronate sodium. Aspirin. Azelastine hydrochloride; Fluticasone propionate. Budesonide; Formoterol fumarate dihydrate. Calcium carbonate; Famotidine; Magnesium hydroxide. Canagliflozin; Metformin hydrochloride. Cyclophosphamide. Cyproheptadine hydrochloride. Dabrafenib mesylate. Dapagliflozin propanediol. Dexbrompheniramine maleate and Pseudoephedrine sulfate. Dolutegravir sodium. Donepezil hydrochloride; Memantine hydrochloride. Doxycycline hyclate. Droxidopa. Eliglustat tartrate. Empagliflozin. Emtricitabine; Tenofovir disoproxil fumarate. Enzalutamide. Fentanyl. Indomethacin. Lanthanum carbonate. Levalbuterol tartrate. Levomilnacipran hydrochloride. Macitentan. Methazolamide. Miglitol. Naloxegol oxalate. Naproxen sodium. Nitroglycerin. Omeprazole; Sodium bicarbonate. Oxybutynin (multiple reference listed drugs and dosage forms). Oxycodone hydrochloride. Primaquine phosphate. Sildenafil citrate. Simeprevir sodium. Sofosbuvir. Tolcapone. Vemurafenib. Vismodegib. Vortioxetine hydrobromide. ------------------------------------------------------------------------ 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 Cholestyramine ------------------------------------------------------------------------ ------------------------------------------------------------------------- Doxycycline hyclate. Prasugrel hydrochloride. Tiagabine hydrochloride. ------------------------------------------------------------------------ For a complete history of previously published Federal Register notices related to product-specific BE recommendations, go to http://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 establish any rights for anyone and are not binding on FDA or the public. You may use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. IV. Comments Interested persons may submit either electronic comments on any of the [[Page 37275]] specific BE recommendations posted on FDA's Web site to http://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 http://www.regulations.gov. V. Electronic Access Persons with access to the Internet may obtain the document at either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov. Dated: June 24, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-16013 Filed 6-29-15; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 80, No. 125 / Tuesday, June 30, 2015 / Notices 37273
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Number of Average
Number of Total annual
Type of respondent Activity responses per burden per Total hours
respondents responses
respondent response
Second follow up young 788 1 788 0.667 (40 min.) ..... 526
adult outcome evalua-
tion questionnaire.
Third follow up young 788 1 788 0.667 (40 min.) ..... 526
adult outcome evalua-
tion questionnaire.
LGBT young adults aged 1st media tracking 1667 1 1667 0.083 (5 min.) ....... 138
18–24 in the select screener.
media markets—Re-
cruited via social media.
1st media tracking ques- 500 1 500 0.667 (40 min.) ..... 334
tionnaire.
2nd media tracking 1667 1 1667 0.083 (5 min.) ....... 138
screener.
2nd media tracking ques- 500 1 500 0.667 (40 min.) ..... 334
tionnaire.
3rd media tracking 1667 1 1667 0.083 (5 min.) ...... 138
screener.
3rd media tracking ques- 500 1 500 0.667 (40 min.) ..... 334
tionnaire.
Total .......................... .......................................... 37,477 ........................ ........................ .............................. 10,819
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: June 24, 2015. recommendations identified in this Hampshire Ave., Bldg. 75, Rm. 4730,
Leslie Kux, notice were developed using the process Silver Spring, MD 20993–0002, 301–
Associate Commissioner for Policy. described in that guidance. 796–5850.
[FR Doc. 2015–16020 Filed 6–29–15; 8:45 am] DATES: Although you can comment on SUPPLEMENTARY INFORMATION:
BILLING CODE 4164–01–P any guidance at any time (see 21 CFR
I. Background
10.115(g)(5)), to ensure that the Agency
considers your comments on these draft In the Federal Register of June 11,
DEPARTMENT OF HEALTH AND and revised draft guidances before it 2010 (75 FR 33311), FDA announced the
HUMAN SERVICES begins work on the final versions of the availability of a guidance for industry
guidances, submit either electronic or entitled ‘‘Bioequivalence
Food and Drug Administration written comments on the draft and Recommendations for Specific
[Docket No. FDA–2007–D–0369] revised draft product-specific BE Products’’ that explained the process
recommendations listed in this notice that would be used to make product-
Product-Specific Bioequivalence by August 31, 2015. specific BE recommendations available
Recommendations; Draft and Revised to the public on FDA’s Web site at
ADDRESSES: Submit written requests for
Draft Guidances for Industry; http://www.fda.gov/Drugs/Guidance
single copies of the individual BE
Availability ComplianceRegulatoryInformation/
guidances to the Division of Drug
Guidances/default.htm.
AGENCY: Food and Drug Administration, Information, Center for Drug Evaluation As described in that guidance, FDA
HHS. and Research, Food and Drug adopted this process as a means to
Administration, 10001 New Hampshire develop and disseminate product-
ACTION: Notice. Ave., Hillandale Bldg., 4th Floor, Silver specific BE recommendations and
SUMMARY: The Food and Drug Spring, MD 20993–0002. Send one self- provide a meaningful opportunity for
Administration (FDA or Agency) is addressed adhesive label to assist that the public to consider and comment on
announcing the availability of office in processing your requests. See those recommendations. Under that
additional draft and revised draft the SUPPLEMENTARY INFORMATION section process, draft recommendations are
product-specific bioequivalence (BE) for electronic access to the draft posted on FDA’s Web site and
recommendations. The guidance recommendations. announced periodically in the Federal
recommendations provide product- Submit electronic comments on the Register. The public is encouraged to
specific guidance on the design of BE draft product-specific BE submit comments on those
studies to support abbreviated new drug recommendations to http:// recommendations within 60 days of
applications (ANDAs). In the Federal www.regulations.gov. Submit written their announcement in the Federal
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Register of June 11, 2010, FDA comments to the Division of Dockets Register. FDA considers any comments
announced the availability of a guidance Management (HFA–305), Food and Drug received and either publishes final
for industry entitled ‘‘Bioequivalence Administration, 5630 Fishers Lane, rm. recommendations or publishes revised
Recommendations for Specific 1061, Rockville, MD 20852. draft recommendations for comment.
Products’’ that explained the process FOR FURTHER INFORMATION CONTACT: Recommendations were last announced
that would be used to make product- Xiaoqiu Tang, Center for Drug in the Federal Register on March 9,
specific BE recommendations available Evaluation and Research, Food and 2015 (80 FR 12502). This notice
to the public on FDA’s Web site. The BE Drug Administration, 10903 New announces draft product-specific
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![Federal Register / Vol. 80, No. 125 / Tuesday, June 30, 2015 / Notices 37275
specific BE recommendations posted on 10.115(g)(5)), to ensure that the Agency legally marketed device in that generic
FDA’s Web site to http:// considers your comment of this draft type of device.
www.regulations.gov or written guidance before it begins work on the Since the original 1988 final rule, a
comments to the Division of Dockets final version of the guidance, submit number of terms have been used to refer
Management (see ADDRESSES). It is only either electronic or written comments to gowns intended for use in health care
necessary to send one set of comments. on the draft guidance by August 31, settings including, but not limited to,
Identify comments with the docket 2015. surgical gowns, isolation gowns,
number found in brackets in the surgical isolation gowns, nonsurgical
heading of this document. The ADDRESSES: An electronic copy of the gowns, procedural gowns, and operating
guidances, notices, and received guidance document is available for room gowns. In 2004, FDA recognized
comments may be seen in the Division download from the Internet. See the the consensus standard American
SUPPLEMENTARY INFORMATION section for National Standards Institute/
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and information on electronic access to the Association of the Advancement of
will be posted to the docket at http:// guidance. Submit written requests for a Medical Instrumentation (ANSI/AAMI)
www.regulations.gov. single hard copy of the guidance PB70:2003, ‘‘Liquid barrier performance
document entitled ‘‘Premarket and classification of protective apparel
V. Electronic Access Notification Requirements Concerning and drapes intended for use in health
Persons with access to the Internet Gowns Intended for Use in Health Care care facilities.’’ ANSI/AAMI PB 70
may obtain the document at either Settings’’ to the Office of the Center utilized new terminology for barrier
http://www.fda.gov/Drugs/Guidance Director, Guidance and Policy performance of gowns. This terminology
ComplianceRegulatoryInformation/ Development, Center for Devices and described and assessed the barrier
Guidances/default.htm or http:// Radiological Health, Food and Drug protection levels of gowns and other
www.regulations.gov. Administration, 10903 New Hampshire protective apparel intended for use in
Dated: June 24, 2015. Ave., Bldg. 66, Rm. 5431, Silver Spring, health care facilities, by specifying test
MD 20993–0002. Send one self- methods and performance results
Leslie Kux,
addressed adhesive label to assist that necessary to verify and validate the
Associate Commissioner for Policy.
office in processing your request. newly defined levels of barrier
[FR Doc. 2015–16013 Filed 6–29–15; 8:45 am]
Submit electronic comments on the protection. The definitions and
BILLING CODE 4164–01–P
draft guidance to http:// terminology used in this standard are
www.regulations.gov. Submit written inconsistent with FDA’s historical
DEPARTMENT OF HEALTH AND comments to the Division of Dockets definitions of these terms and thus have
HUMAN SERVICES Management (HFA–305), Food and Drug added confusion in the marketplace.
Administration, 5630 Fishers Lane, Rm. The purpose of this draft guidance is to
Food and Drug Administration 1061, Rockville, MD 20852. Identify clarify and describe the premarket
comments with the docket number regulatory requirements pertaining to
[Docket No. FDA–2015–D–2261] found in brackets in the heading of this gowns regulated under § 878.4040 and
Premarket Notification Requirements document. the performance testing needed to
Concerning Gowns Intended for Use in FOR FURTHER INFORMATION CONTACT: support liquid barrier claims for gowns
Health Care Settings; Draft Guidance Elizabeth Claverie, Center for Devices intended for use in health care settings.
for Industry and Food and Drug and Radiological Health, Food and Drug II. Significance of Guidance
Administration Staff; Availability Administration, 10903 New Hampshire
This draft guidance is being issued
Ave., Bldg. 66, Rm. 2508, Silver Spring,
AGENCY: Food and Drug Administration, consistent with FDA’s good guidance
MD 20993–0002, 301–796–6298.
HHS. practices regulation (21 CFR 10.115).
SUPPLEMENTARY INFORMATION: The draft guidance represents the
ACTION: Notice.
I. Background Agency’s current thinking on
SUMMARY: The Food and Drug performance testing to support liquid
Administration (FDA) is announcing the FDA issued a final rule on June 24, barrier claims for gowns intended for
availability of the draft guidance 1988 (53 FR 23874), defining ‘‘surgical use in health care settings. It does not
entitled ‘‘Premarket Notification apparel’’ under 21 CFR 878.4040. Under establish any rights for any person and
Requirements Concerning Gowns this 1988 final rule, surgical gowns and is not binding on FDA or the public.
Intended for Use in Health Care surgical masks were classified as Class You can use an alternative approach if
Settings.’’ FDA is issuing this draft II subject to premarket review under it satisfies the requirements of the
guidance to describe the Agency’s section 510(k) (21 U.S.C. 351) of the applicable statutes and regulations.
premarket regulatory requirements and Federal Food, Drug, and Cosmetic Act
the performance testing needed to (the FD&C Act), and surgical apparel III. Electronic Access
support liquid barrier claims for gowns other than surgical gowns and surgical Persons interested in obtaining a copy
intended for use in health care settings. masks were classified as Class I also of the guidance may do so by
This draft guidance is being issued in subject to 510(k) premarket review downloading an electronic copy from
light of the public health importance of requirements. On January 14, 2000, FDA the Internet. A search capability for all
personal protective equipment in health issued a final rule (65 FR 2318) to Center for Devices and Radiological
asabaliauskas on DSK5VPTVN1PROD with NOTICES
care settings and the recognition that designate as exempt from premarket Health guidance documents is available
terminology used to describe gowns has notification requirements surgical at http://www.fda.gov/MedicalDevices/
evolved, including by industry, the apparel other than surgical gowns and DeviceRegulationandGuidance/
standards community, and health care surgical masks, subject to the limitations GuidanceDocuments/default.htm.
professionals. This draft guidance is not of exemptions under 21 CFR 878.9, Guidance documents are also available
final nor is it in effect at this time. which includes requiring a premarket at http://www.regulations.gov. Persons
DATES: Although you can comment on notification for devices intended for a unable to download an electronic copy
any guidance at any time (see 21 CFR use different from the intended use of a of ‘‘Premarket Notification
VerDate Sep<11>2014 17:34 Jun 29, 2015 Jkt 235001 PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 E:\FR\FM\30JNN1.SGM 30JNN1](https://thefederalregister.org/doc/80_FR_37398/page/3.svg)
Document Created: 2018-02-22 11:16:51
Document Modified: 2018-02-22 11:16:51
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| 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 31, 2015. | |
| Contact | Xiaoqiu Tang, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 4730, Silver Spring, MD 20993-0002, 301- 796-5850. | |
| FR Citation | 80 FR 37273 |
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