Homeopathic Product Regulation: Evaluating the Food and Drug Administration's Regulatory Framework After a Quarter-Century; Extension of Comment Period, 32868-32869 [2015-14143]

Download as PDF 32868 Federal Register / Vol. 80, No. 111 / Wednesday, June 10, 2015 / Proposed Rules Justice Reform. If adopted, this rule: would have no retroactive effects: and would not require administrative proceedings before parties may file suit in court challenging this rule. Pursuant to section 23 of the EPIA (21 U.S.C. 1052), states or local jurisdictions are preempted from requiring the use of standards of quality, condition, weight, quantity, or grade which are in addition to or different from Federal standards for any eggs which have moved or are moving in interstate or foreign commerce. Executive Order 13175 This proposed rule has been reviewed in accordance with the requirements of Executive Order 13175. Consultation and coordination with Indian Tribal Governments. The review reveals that this regulation will not have substantial and direct effects on Tribal governments and will not have significant Tribal implications. Paperwork Reduction Act In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35.) the Office of Management and Budget (OMB) has approved the information collection and recordkeeping requirements included in this proposed rule, and there are no new requirements. Should any changes become necessary they would be submitted to OMB for approval. The assigned OMB control number is 0581– 0113. AMS is committed to compliance with the Government Paperwork Elimination Act, which requires Government agencies in general to provide the public the option of submitting information or transacting business electronically to the maximum extent possible. PART 57—INSPECTION OF EGGS (EGG PRODUCTS INSPECTION ACT) 1. The authority citation for part 57 continues to read as follows: ■ Authority: 21 U.S.C. 1031–1056. ■ 2. Revise § 57.920 to read as follows: § 57.920 Importer to make application for inspection of imported eggs. Each person importing any eggs as defined in these regulations, unless exempted by § 57.960 shall make application for inspection upon LPS Form 222—Import Request, to the Chief, Grading Branch, Poultry Programs, AMS, U.S. Department of Agriculture, Washington, DC 20250, or to the Poultry Programs, Grading Branch office nearest the port where the product is to be offered for importation. The application may be filed through electronic submission via QAD.importrequesteggs@ams.usda.gov, or by accessing the U.S. Customs and Border Protection’s International Trade Data System. Application shall be made as far in advance as possible prior to the arrival of the product. Each application shall state the approximate date of product arrival in the United States, the name of the ship or other carrier, the country from which the product was shipped, the destination, the quantity and class of product, and the point of first arrival in the United States. Dated: June 5, 2015. Rex A. Barnes, Associate Administrator, Agricultural Marketing Service. [FR Doc. 2015–14180 Filed 6–9–15; 8:45 am] BILLING CODE 3410–02–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 15 AMS is committed to complying with the E-Government Act to promote the use of the Internet and other information technologies to provide increased opportunities for citizen access to Government information and services, and for other purposes. asabaliauskas on DSK5VPTVN1PROD with PROPOSALS E-Government Act [Docket No. FDA–2015–N–0540] List of Subjects in 7 CFR Part 57 AGENCY: Eggs and egg products, Exports, Food grades and standards, Imports, Reporting and recordkeeping requirements. ACTION: 16:20 Jun 09, 2015 Jkt 235001 Food and Drug Administration, HHS. For the reasons set forth in this Proposed Rule, it is proposed that 7 CFR part 57 be amended as follows: VerDate Sep<11>2014 Homeopathic Product Regulation: Evaluating the Food and Drug Administration’s Regulatory Framework After a Quarter-Century; Extension of Comment Period Notice of public hearing; extension of comment period. 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 SUMMARY: PO 00000 Frm 00002 Fmt 4702 Sfmt 4702 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: https:// 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 https:// 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 https:// 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 E:\FR\FM\10JNP1.SGM 10JNP1 Federal Register / Vol. 80, No. 111 / Wednesday, June 10, 2015 / Proposed Rules 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 https://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 https:// 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 DEPARTMENT OF STATE 22 CFR Part 96 [Public Notice 9165] RIN 1400–AD82 Intercountry Adoptions: Regulatory Change To Prevent Accreditation and Approval Renewal Requests From Coming Due at the Same Time Accreditation (COA), the designated accrediting entity. Permitting some agencies or persons to qualify for an extension by one year of the accreditation or approval period will result in a more even distribution of applications for renewal in a given year. By distributing renewals, and the resources needed to process them, COA will be further enabled to effectively and consistently carry out its other functions. DATES: Comments are due by July 10, 2015. • Internet: You may view this proposed rule and submit your comments by visiting the Regulations.gov Web site at www.regulations.gov, and searching for docket number DOS–2014–0015. • Mail or Delivery: You may send your paper, disk, or CD–ROM submissions to the following address: Comments on Proposed Rule 22 CFR part 96, Office of Legal Affairs, Overseas Citizen Services, U.S. Department of State, CA/OCS/L, SA–17, Floor 10, Washington, DC 20522–1710. • All comments should include the commenter’s name and the organization the commenter represents (if applicable). If the Department is unable to read your comment for any reason, the Department might not be able to consider your comment. Please be advised that all comments will be considered public comments and might be viewed by other commenters; therefore, do not include any information you would not wish to be made public. After the conclusion of the comment period, the Department will publish a final rule (in which it will address relevant comments) as expeditiously as possible. FOR FURTHER INFORMATION CONTACT: Carine Rosalia, Office of Legal Affairs, Overseas Citizen Services, U.S. Department of State, CA/OCS/L, SA–17, Floor 10, Washington, DC 20522–1710; (202) 485–6079. SUPPLEMENTARY INFORMATION: ADDRESSES: AGENCY: Why is the Department promulgating this rulemaking? This proposed rule would amend the Department of State (Department) regulation on the accreditation and approval of adoption service providers in intercountry adoptions. Most agencies and persons currently accredited received that accreditation at approximately the same time, which has resulted in a surge of concurrent renewal applications for consideration by the Council on This proposed rule amends procedural aspects of the Intercountry Adoption Accreditation Regulations concerning the length of accreditation or approval found in 22 CFR part 96. Subpart G governs decisions on applications for accreditation and approval. Section 96.60 provides for accreditation or approval for a period of four years. Section 96.60 does not currently provide the opportunity to stagger the renewal applications, which Department of State. ACTION: Proposed rule. asabaliauskas on DSK5VPTVN1PROD with PROPOSALS SUMMARY: VerDate Sep<11>2014 16:20 Jun 09, 2015 Jkt 235001 PO 00000 Frm 00003 Fmt 4702 Sfmt 4702 32869 results in many renewal applications coming due at the same time. This proposed rule will aid the accrediting entity in managing its workload. In particular, the amendments to this section will allow for a one-year extension of previouslygranted accreditation or approval, not to exceed five years total, based on criteria included in the rule, and summarized here. There will be criteria for selecting which agencies or persons are eligible for the one-year extension. As a threshold matter, only agencies and persons that have no pending adoptionrelated complaint investigations or adverse actions will be eligible for an extension under this procedure. Also, those entities that have undergone a change in corporate or internal structure (such as a merger or a leadership change in chief executive or chief financial officer) since their initial accreditation/ approval or last renewal will not qualify for an extension under this procedure. If the agency or person meets the threshold criteria, in order to ensure that the extension achieves its purpose of staggering renewals thereafter, the Secretary, in his discretion may consider additional factors including, but not limited to, the agency’s or person’s volume of intercountry adoption cases in the year preceding the application for renewal or extension, the agency’s or person’s U.S. state licensure record, and the number of extensions available. Since the President signed into law the Universal Accreditation Act of 2012, approximately 40 new agencies received accreditation, all in the same year. The resulting surge in the number of agencies requiring review in certain years argued strongly for establishing a mechanism that would allow COA to better manage the distribution of renewals. The procedure outlined in this rulemaking will allow a more even distribution of the number of renewals an accrediting entity must review in a given year. The Department invites comment on the procedures described above. Administrative Procedure Act The Department is publishing this notice of proposed rulemaking with a 30-day period for public comments. Regulatory Flexibility Act/Executive Order 13272: Small Business Consistent with section 605(b) of the Regulatory Flexibility Act (5 U.S.C. 605(b)), the Department certifies that this proposed rule does not have a significant economic impact on a substantial number of small entities. For E:\FR\FM\10JNP1.SGM 10JNP1

Agencies

[Federal Register Volume 80, Number 111 (Wednesday, June 10, 2015)]
[Proposed Rules]
[Pages 32868-32869]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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.

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

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: https://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 https://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 https://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 https://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 https://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

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