83_FR_12453 83 FR 12398 - Drug Products Labeled as Homeopathic; Draft Guidance for Staff and Industry; Availability; Extension of Comment Period

83 FR 12398 - Drug Products Labeled as Homeopathic; Draft Guidance for Staff and Industry; Availability; Extension of Comment Period

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 55 (March 21, 2018)

Page Range12398-12399
FR Document2018-05659

The Food and Drug Administration (FDA or Agency) is extending the comment period for the notice entitled ``Drug Products Labeled as Homeopathic; Draft Guidance for Food and Drug Administration Staff and Industry; Availability'' that appeared in the Federal Register of December 20, 2017. The Agency is taking this action to allow interested persons additional time to submit comments.

Federal Register, Volume 83 Issue 55 (Wednesday, March 21, 2018) 
[Federal Register Volume 83, Number 55 (Wednesday, March 21, 2018)]
[Notices]
[Pages 12398-12399]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-05659]



[[Page 12398]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-6580]


Drug Products Labeled as Homeopathic; Draft Guidance for Staff 
and Industry; Availability; Extension of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability; extension of comment period.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is extending 
the comment period for the notice entitled ``Drug Products Labeled as 
Homeopathic; Draft Guidance for Food and Drug Administration Staff and 
Industry; Availability'' that appeared in the Federal Register of 
December 20, 2017. The Agency is taking this action to allow interested 
persons additional time to submit comments.

DATES: FDA is extending the comment period on the notice published 
December 20, 2017 (82 FR 60403). Submit either electronic or written 
comments on the draft guidance by May 21, 2018, to ensure that the 
Agency considers your comment on this draft guidance before it begins 
work on the final version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time 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): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, 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-2017-D-6580 for ``Drug Products Labeled as Homeopathic; Draft 
Guidance for Staff and Industry; Availability; Extension of Comment 
Period.'' 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 Dockets Management Staff 
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 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 https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. 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: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    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 Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    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; or to the 
Office of Communication, Outreach and Development, Center for Biologics 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 71, Rm. 3128, 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: Elaine Lippmann, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6238, Silver Spring, MD 20993-0002, 301-
796-3600; or Stephen Ripley, Center for Biologics Evaluation and 
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911.

SUPPLEMENTARY INFORMATION: 

I. Background

    In the Federal Register of December 20, 2017 (82 FR 60403), FDA 
published a notice with a 90-day comment period to request comments on 
the draft guidance for industry and staff entitled ``Drug Products 
Labeled as Homeopathic.'' FDA is extending the comment period until May 
21, 2018. The Agency believes that a 60-day extension allows adequate 
time for interested persons to submit comments without significantly 
delaying publication of the final version of the guidance.

II. Electronic Access

    Persons with access to the internet may obtain the draft guidance 
at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/

[[Page 12399]]

Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or 
https://www.regulations.gov.

    Dated: March 15, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-05659 Filed 3-20-18; 8:45 am]
 BILLING CODE 4164-01-P

12398 Federal Register / Vol. 83, No. 55 / Wednesday, March 21, 2018 / Notices DEPARTMENT OF HEALTH AND manner detailed (see ‘‘Written/Paper Docket: For access to the docket to HUMAN SERVICES Submissions’’ and ‘‘Instructions’’). read background documents or the electronic and written/paper comments Food and Drug Administration Written/Paper Submissions received, go to https:// Submit written/paper submissions as www.regulations.gov and insert the [Docket No. FDA–2017–D–6580] follows: docket number, found in brackets in the Drug Products Labeled as • Mail/Hand delivery/Courier (for heading of this document, into the Homeopathic; Draft Guidance for Staff written/paper submissions): Dockets ‘‘Search’’ box and follow the prompts and Industry; Availability; Extension of Management Staff (HFA–305), Food and and/or go to the Dockets Management Comment Period Drug Administration, 5630 Fishers Staff, 5630 Fishers Lane, Rm. 1061, Lane, Rm. 1061, Rockville, MD 20852. Rockville, MD 20852. AGENCY: Food and Drug Administration, • For written/paper comments You may submit comments on any HHS. submitted to the Dockets Management guidance at any time (see 21 CFR ACTION:Notice of availability; extension Staff, FDA will post your comment, as 10.115(g)(5)). of comment period. well as any attachments, except for Submit written requests for single information submitted, marked and copies of the draft guidance to the SUMMARY: The Food and Drug identified, as confidential, if submitted Division of Drug Information, Center for Administration (FDA or Agency) is as detailed in ‘‘Instructions.’’ Drug Evaluation and Research, Food extending the comment period for the Instructions: All submissions received and Drug Administration, 10001 New notice entitled ‘‘Drug Products Labeled must include the Docket No. FDA– Hampshire Ave., Hillandale Building, as Homeopathic; Draft Guidance for 2017–D–6580 for ‘‘Drug Products 4th Floor, Silver Spring, MD 20993– Food and Drug Administration Staff and Labeled as Homeopathic; Draft 0002; or to the Office of Industry; Availability’’ that appeared in Guidance for Staff and Industry; Communication, Outreach and the Federal Register of December 20, Availability; Extension of Comment Development, Center for Biologics 2017. The Agency is taking this action Period.’’ Received comments will be Evaluation and Research, Food and to allow interested persons additional placed in the docket and, except for Drug Administration, 10903 New time to submit comments. those submitted as ‘‘Confidential Hampshire Ave., Bldg. 71, Rm. 3128, DATES: FDA is extending the comment Submissions,’’ publicly viewable at Silver Spring, MD 20993–0002. Send period on the notice published https://www.regulations.gov or at the one self-addressed adhesive label to December 20, 2017 (82 FR 60403). Dockets Management Staff between 9 assist that office in processing your Submit either electronic or written a.m. and 4 p.m., Monday through requests. See the SUPPLEMENTARY comments on the draft guidance by May Friday. INFORMATION section for electronic 21, 2018, to ensure that the Agency • Confidential Submissions—To access to the draft guidance document. considers your comment on this draft submit a comment with confidential FOR FURTHER INFORMATION CONTACT: guidance before it begins work on the information that you do not wish to be Elaine Lippmann, Center for Drug final version of the guidance. made publicly available, submit your Evaluation and Research, Food and ADDRESSES: You may submit comments comments only as a written/paper Drug Administration, 10903 New on any guidance at any time as follows: submission. You should submit two Hampshire Ave., Bldg. 51, Rm. 6238, copies total. One copy will include the Silver Spring, MD 20993–0002, 301– Electronic Submissions information you claim to be confidential 796–3600; or Stephen Ripley, Center for Submit electronic comments in the with a heading or cover note that states Biologics Evaluation and Research, following way: ‘‘THIS DOCUMENT CONTAINS Food and Drug Administration, 10903 • Federal eRulemaking Portal: CONFIDENTIAL INFORMATION.’’ The New Hampshire Ave., Bldg. 71, Rm. https://www.regulations.gov. Follow the Agency will review this copy, including 7301, Silver Spring, MD 20993–0002, instructions for submitting comments. the claimed confidential information, in 240–402–7911. Comments submitted electronically, its consideration of comments. The SUPPLEMENTARY INFORMATION: including attachments, to https:// second copy, which will have the www.regulations.gov will be posted to claimed confidential information I. Background the docket unchanged. Because your redacted/blacked out, will be available In the Federal Register of December comment will be made public, you are for public viewing and posted on 20, 2017 (82 FR 60403), FDA published solely responsible for ensuring that your https://www.regulations.gov. Submit a notice with a 90-day comment period comment does not include any both copies to the Dockets Management to request comments on the draft confidential information that you or a Staff. If you do not wish your name and guidance for industry and staff entitled third party may not wish to be posted, contact information to be made publicly ‘‘Drug Products Labeled as such as medical information, your or available, you can provide this Homeopathic.’’ FDA is extending the anyone else’s Social Security number, or information on the cover sheet and not comment period until May 21, 2018. confidential business information, such in the body of your comments and you The Agency believes that a 60-day as a manufacturing process. Please note must identify this information as extension allows adequate time for that if you include your name, contact ‘‘confidential.’’ Any information marked interested persons to submit comments information, or other information that as ‘‘confidential’’ will not be disclosed without significantly delaying identifies you in the body of your except in accordance with 21 CFR 10.20 sradovich on DSK3GMQ082PROD with NOTICES publication of the final version of the comments, that information will be and other applicable disclosure law. For guidance. posted on https://www.regulations.gov. more information about FDA’s posting • If you want to submit a comment of comments to public dockets, see 80 II. Electronic Access with confidential information that you FR 56469, September 18, 2015, or access Persons with access to the internet do not wish to be made available to the the information at: https://www.gpo.gov/ may obtain the draft guidance at https:// public, submit the comment as a fdsys/pkg/FR-2015-09-18/pdf/2015- www.fda.gov/Drugs/Guidance written/paper submission and in the 23389.pdf. ComplianceRegulatoryInformation/ VerDate Sep<11>2014 18:34 Mar 20, 2018 Jkt 244001 PO 00000 Frm 00066 Fmt 4703 Sfmt 4703 E:\FR\FM\21MRN1.SGM 21MRN1

Federal Register / Vol. 83, No. 55 / Wednesday, March 21, 2018 / Notices 12399 Guidances/default.htm, https:// Immunodeficiency Syndrome Research Loan National Cancer Institute, NIH, 9609 Medical www.fda.gov/BiologicsBloodVaccines/ Repayment Program; 93.187, Undergraduate Center Drive, Room 7W264, Bethesda, MD GuidanceComplianceRegulatory Scholarship Program for Individuals from 20892–9750, 240–276–7286, salvucco@ Disadvantaged Backgrounds, National mail.nih.gov. Information/Guidances/default.htm, or Institutes of Health, HHS) (Catalogue of Federal Domestic Assistance https://www.regulations.gov. Dated: March 16, 2018. Program Nos. 93.392, Cancer Construction; Dated: March 15, 2018. 93.393, Cancer Cause and Prevention Natasha M. Copeland, Leslie Kux, Research; 93.394, Cancer Detection and Program Analyst, Office of Federal Advisory Diagnosis Research; 93.395, Cancer Associate Commissioner for Policy. Committee Policy. Treatment Research; 93.396, Cancer Biology [FR Doc. 2018–05659 Filed 3–20–18; 8:45 am] [FR Doc. 2018–05740 Filed 3–20–18; 8:45 am] Research; 93.397, Cancer Centers Support; BILLING CODE 4164–01–P BILLING CODE 4140–01–P 93.398, Cancer Research Manpower; 93.399, Cancer Control, National Institutes of Health, HHS) DEPARTMENT OF HEALTH AND DEPARTMENT OF HEALTH AND Dated: March 16, 2018. HUMAN SERVICES HUMAN SERVICES Melanie J. Pantoja, National Institutes of Health Program Analyst, Office of Federal Advisory National Institutes of Health Committee Policy. Office of The Director, National [FR Doc. 2018–05737 Filed 3–20–18; 8:45 am] National Cancer Institute; Notice of Institutes of Health; Notice of Meeting Closed Meetings BILLING CODE 4140–01–P Pursuant to section 10(d) of the Pursuant to section 10(d) of the Federal Advisory Committee Act, as Federal Advisory Committee Act, as DEPARTMENT OF HEALTH AND amended, notice is hereby given of a amended, notice is hereby given of the HUMAN SERVICES meeting of the Advisory Committee to following meetings. the Director, National Institutes of The meetings will be closed to the National Institutes of Health Health. public in accordance with the The meeting will be held as a National Center for Advancing provisions set forth in sections teleconference call only and is open to Translational Sciences; Notice of 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., the public to dial-in for participation. Meetings as amended. The grant applications and Individuals who plan to dial-in to the the discussions could disclose meeting and need special assistance or Pursuant to section 10(d) of the confidential trade secrets or commercial other reasonable accommodations in Federal Advisory Committee Act, as property such as patentable material, order to do so, should notify the Contact amended, notice is hereby given of and personal information concerning Person listed below in advance of the meetings of the National Center for individuals associated with grant meeting. Advancing Translational Sciences. applications, the disclosure of which Name of Committee: Advisory Committee would constitute a clearly unwarranted The meetings will be open to the to the Director, National Institutes of Health. invasion of personal privacy. public as indicated below, with Date: April 6, 2018. attendance limited to space available. Time: 4:00 p.m. to 5:30 p.m. Name of Committee: National Cancer Institute Special Emphasis Panel; Individuals who plan to attend and Agenda: Report from the Working Group on Ethical Consideration for Industry Approaches to Identify and Care for need special assistance, such as sign Partnership on Research to Help End the Individuals with Inherited Cancer language interpretation or other Opioid Crisis. Syndromes. reasonable accommodations, should Place: National Institutes of Health, Date: April 26, 2018. notify the Contact Person listed below Building 1, One Center Drive, Bethesda, MD Time: 11:00 a.m. to 3:00 p.m. in advance of the meeting. 20892 (Telephone Conference Call), 888– Agenda: To review and evaluate grant The meetings will be closed to the 324–9616, Access Code: 1986191. applications. Contact Person: Gretchen Wood, Staff Place: National Cancer Institute, Shady public in accordance with the Assistant, National Institutes of Health, Grove, 9609 Medical Center Drive, Room provisions set forth in sections Office of the Director, One Center Drive, 7W640 Rockville, MD 20850 (Telephone 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Building 1, Room 126, Bethesda, MD 20892, Conference Call). as amended. The grant applications and 301–496–4272, Woodgs@od.nih.gov. Contact Person: Saejeong J. Kim, Ph.D., the discussions could disclose Any interested person may file written Scientific Review Officer, Special Review confidential trade secrets or commercial comments with the committee by forwarding Branch, Division of Extramural Activities, property such as patentable material, the statement to the Contact Person listed on National Cancer Institute, NIH, 9609 Medical and personal information concerning this notice. The statement should include the Center Drive, Room 7W640, Bethesda, MD individuals associated with the grant name, address, telephone number and when 20892–9750, 240–276–5179, saejeong.kim@ nih.gov. applications, the disclosure of which applicable, the business or professional affiliation of the interested person. would constitute a clearly unwarranted Name of Committee: National Cancer Information is also available on the Institute Special Emphasis Panel; SEP–3: NCI invasion of personal privacy. Institute’s/Center’s home page: http:// Clinical and Translational Exploratory/ Name of Committee: Cures Acceleration acd.od.nih.gov, where an agenda and any Developmental Studies. Network Review Board. additional information for the meeting will Date: June 5–6, 2018. Date: May 10, 2018. be posted when available. Time: 4:00 p.m. to 5:00 p.m. Time: 8:30 a.m. to 3:00 p.m. sradovich on DSK3GMQ082PROD with NOTICES (Catalogue of Federal Domestic Assistance Agenda: To review and evaluate grant Agenda: Report from the Institute Director. Program Nos. 93.14, Intramural Research applications. Place: National Institutes of Health, Training Award; 93.22, Clinical Research Place: Bethesda North Marriott Hotel & Building 31, Conference Room 10, 31 Center Loan Repayment Program for Individuals Conference Center, 5701 Marinelli Road, Drive, Bethesda, MD 20892. from Disadvantaged Backgrounds; 93.232, North Bethesda, MD 20852. Contact Person: Anna L. Ramsey-Ewing, Loan Repayment Program for Research Contact Person: Ombretta Salvucci, Ph.D., Ph.D., Executive Secretary, National Center Generally; 93.39, Academic Research Scientific Review Officer, Special Review for Advancing Translational Sciences, 1 Enhancement Award; 93.936, NIH Acquired Branch, Division of Extramural Activities, Democracy Plaza, Room 1072, Bethesda, MD VerDate Sep<11>2014 18:34 Mar 20, 2018 Jkt 244001 PO 00000 Frm 00067 Fmt 4703 Sfmt 4703 E:\FR\FM\21MRN1.SGM 21MRN1


Document Created: 2018-03-21 00:45:29
Document Modified: 2018-03-21 00:45:29
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; extension of comment period.
DatesFDA is extending the comment period on the notice published December 20, 2017 (82 FR 60403). Submit either electronic or written comments on the draft guidance by May 21, 2018, to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.
ContactElaine Lippmann, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6238, Silver Spring, MD 20993-0002, 301- 796-3600; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911.
FR Citation83 FR 12398 
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