80 FR 32868 - Homeopathic Product Regulation: Evaluating the Food and Drug Administration's Regulatory Framework After a Quarter-Century; Extension of Comment Period

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 111 (June 10, 2015)

Page Range		32868-32869
FR Document		2015-14143

The Food and Drug Administration (FDA) is extending the comment period for the notice of public hearing that appeared in the Federal Register of March 27, 2015. In the notice of public hearing, FDA requested comments on a number of specific questions identified in the document. The Agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.

Federal Register, Volume 80 Issue 111 (Wednesday, June 10, 2015)

[Federal Register Volume 80, Number 111 (Wednesday, June 10, 2015)]
[Proposed Rules]
[Pages 32868-32869]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-14143]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 15

[Docket No. FDA-2015-N-0540]


Homeopathic Product Regulation: Evaluating the Food and Drug 
Administration's Regulatory Framework After a Quarter-Century; 
Extension of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public hearing; extension of comment period.

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SUMMARY: The Food and Drug Administration (FDA) is extending the 
comment period for the notice of public hearing that appeared in the 
Federal Register of March 27, 2015. In the notice of public hearing, 
FDA requested comments on a number of specific questions identified in 
the document. The Agency is taking this action in response to requests 
for an extension to allow interested persons additional time to submit 
comments.

DATES: FDA is extending the comment period on the notice of public 
hearing published March 27, 2015 (80 FR 16327). Submit either 
electronic or written comments by August 21, 2015.

ADDRESSES: You may submit comments by any of the following methods:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.

Written Submissions

    Submit written submissions in the following ways:
     Mail/Hand delivery/Courier (for paper submissions): 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Docket No. 
(FDA-2015-N-0540) for this notice of public hearing. All comments 
received may be posted without change to http://www.regulations.gov, 
including any personal information provided. For additional information 
on submitting comments, see the ``Comments'' heading of the 
SUPPLEMENTARY INFORMATION section of this document.
    Docket: For access to the docket to read background documents or 
comments received, go to http://www.regulations.gov and insert the 
docket number(s), 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.

FOR FURTHER INFORMATION CONTACT: Lesley DeRenzo, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 5161, Silver Spring, MD 20993-0002, 240-
402-4612.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of March 27, 2015, FDA published a notice 
of public hearing with a 60-day comment period following the public 
hearing and requested comments on a number of specific questions 
identified throughout the document. Comments on the notice

[[Page 32869]]

of public hearing will inform FDA's decision about whether and how to 
adjust the current enforcement policies for drug products labeled as 
homeopathic to reflect changes in the homeopathic product marketplace 
over the last approximately 25 years.
    FDA is extending the comment period for an additional 60 days, 
until August 21, 2015. The Agency believes that an additional 60-day 
extension of the comment period for the notice of public hearing will 
allow adequate time for interested persons to submit comments without 
significantly delaying Agency decision making on these important 
issues.

II. Request for Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). You should annotate and 
organize your comments to identify the specific questions or topic to 
which they refer. 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. 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.

    Dated: June 4, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-14143 Filed 6-9-15; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 80, No. 111 / Wednesday, June 10, 2015 / Proposed Rules 32869

of public hearing will inform FDA’s Accreditation (COA), the designated results in many renewal applications
decision about whether and how to accrediting entity. Permitting some coming due at the same time.
adjust the current enforcement policies agencies or persons to qualify for an This proposed rule will aid the
for drug products labeled as extension by one year of the accrediting entity in managing its
homeopathic to reflect changes in the accreditation or approval period will workload. In particular, the
homeopathic product marketplace over result in a more even distribution of amendments to this section will allow
the last approximately 25 years. applications for renewal in a given year. for a one-year extension of previously-
FDA is extending the comment period By distributing renewals, and the granted accreditation or approval, not to
for an additional 60 days, until August resources needed to process them, COA exceed five years total, based on criteria
21, 2015. The Agency believes that an will be further enabled to effectively included in the rule, and summarized
additional 60-day extension of the and consistently carry out its other here.
comment period for the notice of public functions. There will be criteria for selecting
hearing will allow adequate time for which agencies or persons are eligible
DATES: Comments are due by July 10, for the one-year extension. As a
interested persons to submit comments
2015. threshold matter, only agencies and
without significantly delaying Agency
decision making on these important ADDRESSES: • Internet: You may view persons that have no pending adoption-
issues. this proposed rule and submit your related complaint investigations or
comments by visiting the adverse actions will be eligible for an
II. Request for Comments Regulations.gov Web site at extension under this procedure. Also,
Interested persons may submit either www.regulations.gov, and searching for those entities that have undergone a
electronic comments regarding this docket number DOS–2014–0015. change in corporate or internal structure
document to http://www.regulations.gov • Mail or Delivery: You may send (such as a merger or a leadership change
or written comments to the Division of your paper, disk, or CD–ROM in chief executive or chief financial
Dockets Management (see ADDRESSES). submissions to the following address: officer) since their initial accreditation/
You should annotate and organize your Comments on Proposed Rule 22 CFR approval or last renewal will not qualify
comments to identify the specific part 96, Office of Legal Affairs, Overseas for an extension under this procedure.
questions or topic to which they refer. Citizen Services, U.S. Department of If the agency or person meets the
It is only necessary to send one set of State, CA/OCS/L, SA–17, Floor 10, threshold criteria, in order to ensure
comments. Identify comments with the Washington, DC 20522–1710. that the extension achieves its purpose
docket number found in brackets in the • All comments should include the of staggering renewals thereafter, the
heading of this document. Received commenter’s name and the organization Secretary, in his discretion may
comments may be seen in the Division the commenter represents (if consider additional factors including,
of Dockets Management between 9 a.m. applicable). If the Department is unable but not limited to, the agency’s or
and 4 p.m., Monday through Friday, and to read your comment for any reason, person’s volume of intercountry
will be posted to the docket at http:// the Department might not be able to adoption cases in the year preceding the
www.regulations.gov. consider your comment. Please be application for renewal or extension, the
Dated: June 4, 2015. advised that all comments will be agency’s or person’s U.S. state licensure
Leslie Kux, considered public comments and might record, and the number of extensions
Associate Commissioner for Policy. be viewed by other commenters; available.
therefore, do not include any Since the President signed into law
[FR Doc. 2015–14143 Filed 6–9–15; 8:45 am]
information you would not wish to be the Universal Accreditation Act of 2012,
BILLING CODE 4164–01–P approximately 40 new agencies received
made public. After the conclusion of the
comment period, the Department will accreditation, all in the same year. The
publish a final rule (in which it will resulting surge in the number of
DEPARTMENT OF STATE address relevant comments) as agencies requiring review in certain
expeditiously as possible. years argued strongly for establishing a
22 CFR Part 96 mechanism that would allow COA to
FOR FURTHER INFORMATION CONTACT:
[Public Notice 9165] Carine Rosalia, Office of Legal Affairs, better manage the distribution of
Overseas Citizen Services, U.S. renewals. The procedure outlined in
RIN 1400–AD82
Department of State, CA/OCS/L, SA–17, this rulemaking will allow a more even
Intercountry Adoptions: Regulatory Floor 10, Washington, DC 20522–1710; distribution of the number of renewals
Change To Prevent Accreditation and (202) 485–6079. an accrediting entity must review in a
Approval Renewal Requests From given year.
SUPPLEMENTARY INFORMATION: The Department invites comment on
Coming Due at the Same Time
Why is the Department promulgating the procedures described above.
AGENCY: Department of State. this rulemaking? Administrative Procedure Act
ACTION: Proposed rule.
This proposed rule amends The Department is publishing this
SUMMARY: This proposed rule would procedural aspects of the Intercountry notice of proposed rulemaking with a
amend the Department of State Adoption Accreditation Regulations 30-day period for public comments.
asabaliauskas on DSK5VPTVN1PROD with PROPOSALS

(Department) regulation on the concerning the length of accreditation or
accreditation and approval of adoption approval found in 22 CFR part 96. Regulatory Flexibility Act/Executive
service providers in intercountry Subpart G governs decisions on Order 13272: Small Business
adoptions. Most agencies and persons applications for accreditation and Consistent with section 605(b) of the
currently accredited received that approval. Section 96.60 provides for Regulatory Flexibility Act (5 U.S.C.
accreditation at approximately the same accreditation or approval for a period of 605(b)), the Department certifies that
time, which has resulted in a surge of four years. Section 96.60 does not this proposed rule does not have a
concurrent renewal applications for currently provide the opportunity to significant economic impact on a
consideration by the Council on stagger the renewal applications, which substantial number of small entities. For

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Document Created: 2015-12-15 15:17:30
Document Modified: 2015-12-15 15:17:30

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		Proposed Rules
Action		Notice of public hearing; extension of comment period.
Dates		FDA is extending the comment period on the notice of public hearing published March 27, 2015 (80 FR 16327). Submit either electronic or written comments by August 21, 2015.
Contact		Lesley DeRenzo, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 5161, Silver Spring, MD 20993-0002, 240- 402-4612.
FR Citation		80 FR 32868

80 FR 32868 - Homeopathic Product Regulation: Evaluating the Food and Drug Administration's Regulatory Framework After a Quarter-Century; Extension of Comment Period

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 111 (June 10, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration