81_FR_94641 81 FR 94394 - Product-Specific Bioequivalence Recommendations; Draft and Revised Draft Guidances for Industry; Availability

81 FR 94394 - 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 81, Issue 247 (December 23, 2016)

Page Range94394-94396
FR Document2016-30984

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.

Federal Register, Volume 81 Issue 247 (Friday, December 23, 2016) 
[Federal Register Volume 81, Number 247 (Friday, December 23, 2016)]
[Notices]
[Pages 94394-94396]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-30984]


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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 of availability.

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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 comment on this 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by February 21, 2017.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2007-D-0369 for ``Product-Specific Bioequivalence Recommendations; 
Draft and Revised Draft Guidances for Industry.'' Received comments 
will be placed in the docket and, except for those submitted as 
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Division of Dockets Management between 9 
a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the

[[Page 94395]]

information you claim to be confidential with a heading or cover note 
that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The 
Agency will review this copy, including the claimed confidential 
information, in its consideration of comments. The second copy, which 
will have the claimed confidential information redacted/blacked out, 
will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets 
Management. If you do not wish your name and contact information to be 
made publicly available, you can provide this information on the cover 
sheet and not in the body of your comments and you must identify this 
information as ``confidential.'' Any information marked as 
``confidential'' will not be disclosed except in accordance with 21 CFR 
10.20 and other applicable disclosure law. For more information about 
FDA's posting of comments to public dockets, see 80 FR 56469, September 
18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of the draft guidance to 
the Division of Drug Information, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10001 New Hampshire Ave., 
Hillandale Building, 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 document.

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 
October 5, 2016 (81 FR 69064). This notice announces draft product-
specific BE 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
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1. Adapalene; benzoyl peroxide.
2. Amphetamine.
3. Betamethasone valerate.
4. Budesonide.
5. Cephalexin.
6. Cetirizine hydrochloride.
7. Clozapine.
8. Colchicine.
9. Doxycycline hyclate.
10. Emtricitabine; Rilpivirine hydrochloride; Tenofovir alafenamide
 fumarate.
11. Emtricitabine; Tenofovir alafenamide fumarate.
12. Epinephrine.
13. Esomeprazole Magnesium.
14. Ethiodized oil.
15. Fenofibrate.
16. Fluocinonide.
17. Fluoxetine hydrochloride.
18. Halcinonide.
19. Ibuprofen; pseudoephedrine hydrochloride.
20. Lidocaine.
21. Morphine sulfate.
22. Nicotine polacrilex.
23. Nitisinone.
24. Omega-3-acid ethyl esters type A.
25. Oxycodone.
26. Panobinostat lactate.
27. Perampanel.
28. Pimavanserin tartrate.
29. Prazosin hydrochloride.
30. Simvastatin.
31. Tofacitinib citrate.
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II. 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
------------------------------------------------------------------------
 
-------------------------------------------------------------------------
Acyclovir.
Albuterol sulfate.
Buprenorphine hydrochloride; Naloxone hydrochloride (multiple reference
 listed drugs).
Cobicistat; Darunavir ethanolate.
Divalproex sodium (multiple reference listed drugs).
Levomilnacipran hydrochloride.
Medroxyprogesterone acetate.
Nepafenac (multiple reference listed drugs).
Omega-3-acid ethyl esters.
Omega-3-carboxylic acids.
Ruxolitinib phosphate.
Tedizolid phosphate.
Venlafaxine hydrochloride.
------------------------------------------------------------------------

    For a complete history of previously published Federal Register 
notices related to product-specific BE recommendations, go to https://www.regulations.gov and enter Docket No. FDA-2007-D-0369.
    These draft guidances are being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). These draft guidances, 
when finalized, will represent the current thinking of FDA on the 
product-specific design of BE studies to support ANDAs. They do not 
establish any rights for any person and are not binding on FDA or the 
public. You can use an alternative approach if it satisfies the 
requirements of the applicable statutes and regulations.

III. Electronic Access

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


[[Page 94396]]


    Dated: December 16, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-30984 Filed 12-22-16; 8:45 am]
 BILLING CODE 4164-01-P

94394 Federal Register / Vol. 81, No. 247 / Friday, December 23, 2016 / Notices IV. List of Recognized Standards announcing ‘‘Modification to the List of Electronic Submissions FDA maintains the Agency’s current Recognized Standards, Recognition List Submit electronic comments in the list of FDA Recognized Consensus Number: 046’’ will be available at http:// following way: Standards in a searchable database that www.fda.gov/MedicalDevices/ • Federal eRulemaking Portal: may be accessed directly at FDA’s DeviceRegulationandGuidance/ https://www.regulations.gov. Follow the Internet site at http:// Standards/ucm123792.htm. You may instructions for submitting comments. www.accessdata.fda.gov/scripts/cdrh/ access ‘‘Guidance on the Recognition Comments submitted electronically, cfdocs/cfStandards/search.cfm. FDA and Use of Consensus Standards,’’ and including attachments, to https:// will incorporate the modifications and the searchable database for ‘‘FDA www.regulations.gov will be posted to revisions described in this notice into Recognized Consensus Standards’’ at the docket unchanged. Because your the database and, upon publication in http://www.fda.gov/MedicalDevices/ comment will be made public, you are the Federal Register, this recognition of DeviceRegulationandGuidance/ solely responsible for ensuring that your consensus standards will be effective. Standards. comment does not include any FDA will announce additional Dated: December 19, 2016. confidential information that you or a modifications and revisions to the list of Leslie Kux, third party may not wish to be posted, recognized consensus standards, as Associate Commissioner for Policy. such as medical information, your or needed, in the Federal Register once a [FR Doc. 2016–31008 Filed 12–22–16; 8:45 am] anyone else’s Social Security number, or year, or more often if necessary. BILLING CODE 4164–01–P confidential business information, such Beginning with Recognition List 033, as a manufacturing process. Please note FDA no longer announces minor that if you include your name, contact revisions to the list of recognized DEPARTMENT OF HEALTH AND information, or other information that consensus standards such as technical HUMAN SERVICES identifies you in the body of your contact person, devices affected, comments, that information will be processes affected, Code of Federal Food and Drug Administration posted on https://www.regulations.gov. Regulations citations, and product • If you want to submit a comment codes. [Docket No. FDA–2007–D–0369] with confidential information that you do not wish to be made available to the V. Recommendation of Standards for Product-Specific Bioequivalence public, submit the comment as a Recognition by FDA Recommendations; Draft and Revised written/paper submission and in the Any person may recommend Draft Guidances for Industry; manner detailed (see ‘‘Written/Paper consensus standards as candidates for Availability Submissions’’ and ‘‘Instructions’’). recognition under section 514 of the AGENCY: Food and Drug Administration, Written/Paper Submissions FD&C Act by submitting such HHS. recommendations, with reasons for the Submit written/paper submissions as recommendation, to standards@ ACTION: Notice of availability. follows: cdrh.fda.gov. To be properly considered, SUMMARY: The Food and Drug • Mail/Hand delivery/Courier (for such recommendations should contain, Administration (FDA or Agency) is written/paper submissions): Division of at a minimum, the following announcing the availability of Dockets Management (HFA–305), Food information: (1) Title of the standard, (2) additional draft and revised draft and Drug Administration, 5630 Fishers any reference number and date, (3) product-specific bioequivalence (BE) Lane, Rm. 1061, Rockville, MD 20852. name and address of the national or recommendations. The • For written/paper comments international standards development recommendations provide product- submitted to the Division of Dockets organization, (4) a proposed list of specific guidance on the design of BE Management, FDA will post your devices for which a declaration of studies to support abbreviated new drug comment, as well as any attachments, conformity to this standard should applications (ANDAs). In the Federal except for information submitted, routinely apply, and (5) a brief Register of June 11, 2010, FDA marked and identified, as confidential, identification of the testing or announced the availability of a guidance if submitted as detailed in performance or other characteristics of for industry entitled ‘‘Bioequivalence ‘‘Instructions.’’ the device(s) that would be addressed Recommendations for Specific Instructions: All submissions received by a declaration of conformity. Products’’ that explained the process must include the Docket No. FDA– that would be used to make product- 2007–D–0369 for ‘‘Product-Specific VI. Electronic Access Bioequivalence Recommendations; Draft specific BE recommendations available You may obtain a copy of ‘‘Guidance to the public on FDA’s Web site. The BE and Revised Draft Guidances for on the Recognition and Use of recommendations identified in this Industry.’’ Received comments will be Consensus Standards’’ by using the notice were developed using the process placed in the docket and, except for Internet. The Center for Devices and described in that guidance. those submitted as ‘‘Confidential Radiological Health (CDRH) maintains a Submissions,’’ publicly viewable at DATES: Although you can comment on site on the Internet for easy access to https://www.regulations.gov or at the information including text, graphics, any guidance at any time (see 21 CFR Division of Dockets Management and files that you may download to a 10.115(g)(5)), to ensure that the Agency between 9 a.m. and 4 p.m., Monday personal computer with access to the considers your comment on this draft through Friday. mstockstill on DSK3G9T082PROD with NOTICES Internet. Updated on a regular basis, the guidance before it begins work on the • Confidential Submissions—To CDRH home page, http://www.fda.gov/ final version of the guidance, submit submit a comment with confidential MedicalDevices, includes a link to either electronic or written comments information that you do not wish to be standards-related documents including on the draft guidance by February 21, made publicly available, submit your the guidance and the current list of 2017. comments only as a written/paper recognized standards. After publication ADDRESSES: You may submit comments submission. You should submit two in the Federal Register, this notice as follows: copies total. One copy will include the VerDate Sep<11>2014 18:33 Dec 22, 2016 Jkt 241001 PO 00000 Frm 00083 Fmt 4703 Sfmt 4703 E:\FR\FM\23DEN1.SGM 23DEN1

Federal Register / Vol. 81, No. 247 / Friday, December 23, 2016 / Notices 94395 information you claim to be confidential Products’’ that explained the process TABLE 1—NEW DRAFT PRODUCT-SPE- with a heading or cover note that states that would be used to make product- CIFIC BE RECOMMENDATIONS FOR ‘‘THIS DOCUMENT CONTAINS specific BE recommendations available DRUG PRODUCTS—Continued CONFIDENTIAL INFORMATION.’’ The to the public on FDA’s Web site at Agency will review this copy, including http://www.fda.gov/Drugs/Guidance 23. Nitisinone. the claimed confidential information, in ComplianceRegulatoryInformation/ 24. Omega-3-acid ethyl esters type A. its consideration of comments. The Guidances/default.htm. 25. Oxycodone. As described in that guidance, FDA 26. Panobinostat lactate. second copy, which will have the 27. Perampanel. claimed confidential information adopted this process as a means to 28. Pimavanserin tartrate. redacted/blacked out, will be available develop and disseminate product- 29. Prazosin hydrochloride. for public viewing and posted on http:// specific BE recommendations and 30. Simvastatin. www.regulations.gov. Submit both provide a meaningful opportunity for 31. Tofacitinib citrate. copies to the Division of Dockets the public to consider and comment on Management. If you do not wish your those recommendations. Under that II. Drug Products for Which Revised name and contact information to be process, draft recommendations are Draft Product-Specific BE made publicly available, you can posted on FDA’s Web site and Recommendations Are Available provide this information on the cover announced periodically in the Federal FDA is announcing the availability of sheet and not in the body of your Register. The public is encouraged to a revised draft guidance for industry on comments and you must identify this submit comments on those product-specific BE recommendations information as ‘‘confidential.’’ Any recommendations within 60 days of for drug products containing the information marked as ‘‘confidential’’ their announcement in the Federal following active ingredients: will not be disclosed except in Register. FDA considers any comments accordance with 21 CFR 10.20 and other received and either publishes final TABLE 2—REVISED DRAFT PRODUCT- applicable disclosure law. For more recommendations or publishes revised SPECIFIC BE RECOMMENDATIONS information about FDA’s posting of draft recommendations for comment. FOR DRUG PRODUCTS comments to public dockets, see 80 FR Recommendations were last announced 56469, September 18, 2015, or access in the Federal Register on October 5, Acyclovir. the information at: http://www.fda.gov/ 2016 (81 FR 69064). This notice Albuterol sulfate. regulatoryinformation/dockets/ announces draft product-specific BE Buprenorphine hydrochloride; Naloxone hy- default.htm. recommendations, either new or drochloride (multiple reference listed Docket: For access to the docket to revised, that are posted on FDA’s Web drugs). read background documents or the site. Cobicistat; Darunavir ethanolate. electronic and written/paper comments Divalproex sodium (multiple reference listed II. Drug Products for Which New Draft drugs). received, go to https:// Product-Specific BE Recommendations Levomilnacipran hydrochloride. www.regulations.gov and insert the Are Available Medroxyprogesterone acetate. docket number, found in brackets in the Nepafenac (multiple reference listed drugs). heading of this document, into the FDA is announcing the availability of Omega-3-acid ethyl esters. ‘‘Search’’ box and follow the prompts a new draft guidance for industry on Omega-3-carboxylic acids. and/or go to the Division of Dockets product-specific BE recommendations Ruxolitinib phosphate. Management, 5630 Fishers Lane, Rm. for drug products containing the Tedizolid phosphate. 1061, Rockville, MD 20852. following active ingredients: Venlafaxine hydrochloride. Submit written requests for single copies of the draft guidance to the TABLE 1—NEW DRAFT PRODUCT-SPE- For a complete history of previously Division of Drug Information, Center for CIFIC BE RECOMMENDATIONS FOR published Federal Register notices DRUG PRODUCTS related to product-specific BE Drug Evaluation and Research, Food recommendations, go to https:// and Drug Administration, 10001 New www.regulations.gov and enter Docket Hampshire Ave., Hillandale Building, 1. Adapalene; benzoyl peroxide. 2. Amphetamine. No. FDA–2007–D–0369. 4th Floor, Silver Spring, MD 20993– These draft guidances are being 0002. Send one self-addressed adhesive 3. Betamethasone valerate. 4. Budesonide. issued consistent with FDA’s good label to assist that office in processing 5. Cephalexin. guidance practices regulation (21 CFR your requests. See the SUPPLEMENTARY 6. Cetirizine hydrochloride. 10.115). These draft guidances, when INFORMATION section for electronic 7. Clozapine. finalized, will represent the current access to the draft guidance document. 8. Colchicine. thinking of FDA on the product-specific FOR FURTHER INFORMATION CONTACT: 9. Doxycycline hyclate. design of BE studies to support ANDAs. Xiaoqiu Tang, Center for Drug 10. Emtricitabine; Rilpivirine hydrochloride; Tenofovir alafenamide fumarate. They do not establish any rights for any Evaluation and Research, Food and 11. Emtricitabine; Tenofovir alafenamide fu- person and are not binding on FDA or Drug Administration, 10903 New marate. the public. You can use an alternative Hampshire Ave., Bldg. 75, Rm. 4730, 12. Epinephrine. approach if it satisfies the requirements Silver Spring, MD 20993–0002, 301– 13. Esomeprazole Magnesium. of the applicable statutes and 796–5850. 14. Ethiodized oil. regulations. 15. Fenofibrate. mstockstill on DSK3G9T082PROD with NOTICES SUPPLEMENTARY INFORMATION: 16. Fluocinonide. III. Electronic Access I. Background 17. Fluoxetine hydrochloride. Persons with access to the Internet 18. Halcinonide. In the Federal Register of June 11, may obtain the draft guidance at either 19. Ibuprofen; pseudoephedrine hydro- 2010 (75 FR 33311), FDA announced the chloride. http://www.fda.gov/Drugs/Guidance availability of a guidance for industry 20. Lidocaine. ComplianceRegulatoryInformation/ entitled ‘‘Bioequivalence 21. Morphine sulfate. Guidances/default.htm or https:// Recommendations for Specific 22. Nicotine polacrilex. www.regulations.gov. VerDate Sep<11>2014 18:33 Dec 22, 2016 Jkt 241001 PO 00000 Frm 00084 Fmt 4703 Sfmt 4703 E:\FR\FM\23DEN1.SGM 23DEN1

94396 Federal Register / Vol. 81, No. 247 / Friday, December 23, 2016 / Notices Dated: December 16, 2016. FOR FURTHER INFORMATION CONTACT: ash/carb/ when it has been finalized. Leslie Kux, Bruce Gellin, Designated Federal All agenda items are tentative and Associate Commissioner for Policy. Officer, Presidential Advisory Council subject to change. [FR Doc. 2016–30984 Filed 12–22–16; 8:45 am] on Combating Antibiotic-Resistant Public attendance at the meeting is BILLING CODE 4164–01–P Bacteria, Office of the Assistant limited to the available space. Secretary for Health, U.S. Department of Individuals who plan to attend and Health and Human Services, Room need special assistance, such as sign DEPARTMENT OF HEALTH AND 715H, Hubert H. Humphrey Building, language interpretation or other HUMAN SERVICES 200 Independence Avenue SW., reasonable accommodations, should Washington, DC 20201. Phone: (202) notify the Advisory Council at the Meeting of the Presidential Advisory 260–6638; email: CARB@hhs.gov. address/telephone number listed above Council on Combating Antibiotic- SUPPLEMENTARY INFORMATION: Under at least one week prior to the meeting. Resistant Bacteria Executive Order 13676, dated For those unable to attend in person, a September 18, 2014, authority was given live webcast will be available. More AGENCY: Office of the Assistant information on registration and Secretary for Health, Office of the to the Secretary of HHS to establish the Advisory Council, in consultation with accessing the webcast can be found at Secretary, Department of Health and http://www.hhs.gov/ash/carb/. Human Services. the Secretaries of Defense and Agriculture. Activities of the Advisory Members of the public will have the ACTION: Notice. Council are governed by the provisions opportunity to provide comments prior of Public Law 92–463, as amended (5 to the Advisory Council meeting by SUMMARY: As stipulated by the Federal emailing CARB@hhs.gov. Public Advisory Committee Act, the U.S.C. App.), which sets forth standards for the formation and use of federal comments should be sent in by Department of Health and Human midnight January 20, 2017, and should Services (HHS) is hereby giving notice advisory committees. The Advisory Council provides be limited to no more than one page. All that a meeting is scheduled to be held public comments received prior to for the Presidential Advisory Council on advice, information, and recommendations to the Secretary of January 20, 2017, will be provided to Combating Antibiotic-Resistant Bacteria Advisory Council members; comments (Advisory Council). The meeting will be HHS regarding programs and policies intended to support and evaluate the are limited to two minutes per speaker. open to the public; a public comment session will be held during the meeting. implementation of Executive Order Dated: December 16, 2016. Pre-registration is required for members 13676, including the National Strategy Bruce Gellin, of the public who wish to attend the for Combating Antibiotic-Resistant Designated Federal Officer, Presidential meeting and who wish to participate in Bacteria and the National Action Plan Advisory Council on Combating Antibiotic- the public comment session. Individuals for Combating Antibiotic-Resistant Resistant Bacteria, Deputy Assistant Secretary who wish to attend the meeting and/or Bacteria. The Advisory Council for Health. send in their public comment via email functions solely for advisory purposes. [FR Doc. 2016–30904 Filed 12–22–16; 8:45 am] should send an email to CARB@hhs.gov. In carrying out its mission, the BILLING CODE 4150–44–P Registration information is available on Advisory Council provides advice, the Web site http://www.hhs.gov/ash/ information, and recommendations to carb/ and must be completed by January the Secretary regarding programs and DEPARTMENT OF HEALTH AND 20, 2017; all in-person attendees must policies intended to preserve the HUMAN SERVICES pre-register by this date. Additional effectiveness of antibiotics by optimizing their use; advance research National Institutes of Health information about registering for the meeting and providing public comment to develop improved methods for combating antibiotic resistance and Center for Scientific Review; Notice of can be obtained at http://www.hhs.gov/ Closed Meetings ash/carb/ on the Meetings page. conducting antibiotic stewardship; strengthen surveillance of antibiotic- Pursuant to section 10(d) of the DATES: The meeting is scheduled to be resistant bacterial infections; prevent Federal Advisory Committee Act, as held on January 25, 2017, from 9:30 a.m. the transmission of antibiotic-resistant amended (5 U.S.C. App.), notice is to 5:00 p.m. ET (times are tentative and bacterial infections; advance the hereby given of the following meetings. subject to change). The confirmed times development of rapid point-of-care and The meetings will be closed to the and agenda items for the meeting will be agricultural diagnostics; further research public in accordance with the posted on the Web site for the Advisory on new treatments for bacterial provisions set forth in sections Council at http://www.hhs.gov/ash/ infections; develop alternatives to 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., carb/ when this information becomes antibiotics for agricultural purposes; as amended. The grant applications and available. Pre-registration for attending maximize the dissemination of up-to- the discussions could disclose the meeting in person is required to be date information on the appropriate and confidential trade secrets or commercial completed no later than January 20, proper use of antibiotics to the general property such as patentable material, 2017; public attendance at the meeting public and human and animal and personal information concerning is limited to the available space. healthcare providers; and improve individuals associated with the grant ADDRESSES: U.S. Department of Health international coordination of efforts to applications, the disclosure of which and Human Services, Hubert H. combat antibiotic resistance. mstockstill on DSK3G9T082PROD with NOTICES would constitute a clearly unwarranted Humphrey Building, Great Hall, 200 The January public meeting will be invasion of personal privacy. Independence Avenue SW., dedicated to presentations from federal Name of Committee: Center for Scientific Washington, DC 20201. and non-federal stakeholders Review Special Emphasis Panel; PAR Panel: The meeting can also be accessed surrounding the topic areas of infection Global Infectious Diseases Research Training through a live webcast on the day of the prevention and control. The meeting Program. meeting. For more information, visit agenda will be posted on the Advisory Date: January 5, 2017. http://www.hhs.gov/ash/carb/. Council Web site at http://www.hhs.gov/ Time: 9:00 a.m. to 12:00 p.m. VerDate Sep<11>2014 18:33 Dec 22, 2016 Jkt 241001 PO 00000 Frm 00085 Fmt 4703 Sfmt 4703 E:\FR\FM\23DEN1.SGM 23DEN1


Document Created: 2016-12-23 12:30:05
Document Modified: 2016-12-23 12:30:05
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice of availability.
DatesAlthough you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by February 21, 2017.
ContactXiaoqiu 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 Citation81 FR 94394 
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