Preparation for International Cooperation on Cosmetics Regulation, 41506-41507 [2015-17248]

Download as PDF 41506 Federal Register / Vol. 80, No. 135 / Wednesday, July 15, 2015 / Notices respondents to provide contact data for possible longer-term follow-up. Respondents: JSA study participants and program staff. Annual Burden Estimates EXTENSION OF PREVIOUSLY APPROVED INFORMATION COLLECTIONS Total number of respondents Instrument Baseline Information Form ................................................... Implementation Study Site Visits ......................................... JSA Staff Survey .................................................................. Annual number of respondents 6,400 600 440 Number of responses per respondent 3,200 300 220 1 1 1 Average burden hours per response Annual burden hours .2 1 .33 640 300 73 PROPOSED NEW INFORMATION COLLECTIONS Total number of respondents Instrument mstockstill on DSK4VPTVN1PROD with NOTICES 6 Month Follow-Up Survey .................................................. Contact Update Form .......................................................... Estimated Total Annual Burden Hours: 3,241. In compliance with the requirements of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Administration for Children and Families is soliciting public comment on the specific aspects of the information collection described above. Copies of the proposed collection of information can be obtained and comments may be forwarded by writing to the Administration for Children and Families, Office of Planning, Research and Evaluation, 370 L’Enfant Promenade SW., Washington, DC 20447, Attn: OPRE Reports Clearance Officer. Email address: OPREinfocollection@ acf.hhs.gov. All requests should be identified by the title of the information collection. The Department specifically requests comments on (a) whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency’s estimate of the burden of the proposed collection of information; (c) the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Consideration will be given to comments and suggestions submitted within 60 days of this publication. Karl Koerper, Reports Clearance Officer. [FR Doc. 2015–17264 Filed 7–14–15; 8:45 am] BILLING CODE 4184–01–P VerDate Sep<11>2014 18:52 Jul 14, 2015 Jkt 235001 Annual number of respondents 6,400 6,400 3,200 3,200 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2015–N–0001] Preparation for International Cooperation on Cosmetics Regulation AGENCY: Food and Drug Administration, HHS. ACTION: Notice of meeting. The Food and Drug Administration (FDA or we) is announcing a public meeting entitled ‘‘International Cooperation on Cosmetics Regulation (ICCR)—Preparation for ICCR–9 Meeting.’’ The purpose of the meeting is to invite public input on various topics pertaining to the regulation of cosmetics. We may use this input to help us prepare for the ICCR–9 meeting that will be held November 4–6, 2015, in Brussels, Belgium. Date and Time: The public meeting will be held on September 10, 2015, from 2 p.m. to 4 p.m. Location: This meeting will be held at the Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5100 Paint Branch Pkwy., Wiley Auditorium (first floor), College Park, MD 20740. Contact Person: Maria Rossana (Rosemary) Cook, Office of Cosmetics and Colors, Food and Drug Administration, 4300 River Rd., College Park, MD 20740, email: maria.cook@ fda.hhs.gov, or FAX: 301–436–2975. Registration and Requests for Oral Presentations: Send registration information (including your name, title, firm name, address, telephone number, fax number, and email address), written material, and requests to make an oral PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 Number of responses per respondent 1 11 Average burden hours per response Annual burden hours .333 .033 1,066 1,162 presentation, to the contact person by August 27, 2015. If you need special accommodations due to a disability, please contact Maria Rossana (Rosemary) Cook by September 3, 2015. You may present proposals for future ICCR agenda items, data, information, or views, orally or in writing, on issues pending at the public meeting. Time allotted for oral presentations may be limited to 10 minutes or less for each presenter. If you wish to make an oral presentation, you should notify the contact person by August 27, 2015, and submit a brief statement of the general nature of the evidence or arguments that you wish to present, your name, address, telephone number, fax number, and email address, and indicate the approximate amount of time you need to make your presentation. Transcripts: As soon as a transcript is available, it will be accessible at http://www.regulations.gov. It may also be viewed at the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20850. A transcript will also be available in either hardcopy or on CD–ROM, after submission of a Freedom of Information request. Written requests are to be sent to the Division of Freedom of Information, (ELEM– 1029), Food and Drug Administration, 12420 Parklawn Dr., Element Bldg., Rockville, MD 20857. The Purpose of the Multilateral Framework on the ICCR: The purpose of the multilateral framework on the ICCR is to pave the way for the removal of regulatory obstacles to international trade while maintaining global consumer protection. SUPPLEMENTARY INFORMATION: E:\FR\FM\15JYN1.SGM 15JYN1 41507 Federal Register / Vol. 80, No. 135 / Wednesday, July 15, 2015 / Notices ICCR is a voluntary international group of cosmetics regulatory authorities from the United States, Japan, the European Union, Canada, and Brazil. These regulatory authority members will enter into constructive dialogue with their relevant cosmetics industry trade associations and public advocacy groups. Currently, the ICCR members are: Health Canada; the European Commission DirectorateGeneral for Internal Market, Industry, Entrepreneurship, and Subject Matter Experts; the Ministry of Health, Labor, and Welfare of Japan; the Brazilian Health Surveillance Agency; and FDA. All decisions made by consensus will be compatible with the laws, policies, rules, regulations, and directives of the respective administrations and governments. Members will implement and/or promote actions or documents within their own jurisdictions and seek convergence of regulatory policies and practices. Successful implementation will need input from stakeholders. Agenda: We will make the agenda for the public meeting available on the Internet at http://www.fda.gov/ Cosmetics/InternationalActivities/ICCR/ default.htm. Depending on the number of requests for oral presentations, we intend to have an agenda available by September 3, 2015. We may use the information that you provide to us during the public meeting to help us prepare for the November 4–6, 2015, ICCR–9 meeting. Dated: July 9, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–17248 Filed 7–14–15; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES [Document Identifier: HHS–0990–0279–60D] Agency Information Collection Activities; Proposed Collection; Public Comment Request Office of the Assistant Secretary for Health, HHS. AGENCY: ACTION: approve, and have continuing oversight of research involving human subjects. The Office for Human Research Protections (OHRP) and the Food and Drug Administration (FDA) are requesting a three-year extension of the OMB No. 0990–0279, Institutional Review Board (IRB) Registration Form. This form was modified in 2009 to be consistent with IRB registration requirements, 45 CFR part 46, subpart E and 21 CFR 56.106 that were adopted in July 2009 OHRP and FDA, respectively. Need and Proposed Use of the Information: The information collected through the Institutional Review Board registration collection requirements is the minimum necessary to satisfy the registration requirements of Section 491 (a) of the Public Health Service Act, 45 CFR part 46, subpart E and 21 CFR 56.106. Likely Respondents: Institutions or organizations operating IRBs that review human subjects research conducted or supported by HHS, or, in the case of FDA’s regulations, IRBs in the United States that review clinical investigations regulated by FDA under sections 505(i) or 520(g) of the Federal Food, Drug and Cosmetic Act; and, IRBs in the United States that review clinical investigations that are intended to support applications for research or marketing permits for FDA-regulated products. Burden Statement: The burden estimates for the IRB registration form include those approved by OMB in March 2015 under Control Number 0990–0263, the Assurance Identification/IRB Certification/ Declaration of Exemption form (former Optional Form 310). Those burden estimates are not included as part of the burden estimate presented below. Notice. In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the Secretary, Department of Health and Human Services (HHS), announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). The ICR is for extending the use of the approved information collection assigned OMB control number 0990–0279, which expires on August 31, 2015. Prior to submitting that ICR to OMB, OS seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR. DATES: Comments on the ICR must be received on or before September 14, 2015. SUMMARY: Submit your comments to Information.CollectionClearance@ hhs.gov or by calling (202) 690–6162. FOR FURTHER INFORMATION CONTACT: Information Collection Clearance staff, Information.CollectionClearance@ hhs.gov or (202) 690–6162. SUPPLEMENTARY INFORMATION: When submitting comments or requesting information, please include the document identifier 0990–0279 for reference. Information Collection Request Title: Institutional Review Board Form—OMB No. 0990–0279, Assistant Secretary for Health, Office for Human Research Protections. Abstract: Section 491(a) of Public Law 99–158 states that the Secretary of HHS shall by regulation require that each entity applying for HHS support (e.g., a grant, contract, or cooperative agreement) to conduct research involving human subjects submit to HHS assurances satisfactory to the Secretary that it has established an institutional review board (IRB) to review the research in order to ensure protection of the rights and welfare of the human research subjects. IRBs are boards, committees, or groups formally designated by an entity to review, ADDRESSES: ESTIMATED ANNUALIZED BURDEN TABLE Number of respondents mstockstill on DSK4VPTVN1PROD with NOTICES Form name Number of responses per respondent Average burden per response (in hours) Total burden hours IRB Registration 0990–0279 ........................................................................... 5,900 500 2 2 1 1 11,800 1,000 Total .......................................................................................................... ........................ ........................ ........................ 12,800 VerDate Sep<11>2014 18:52 Jul 14, 2015 Jkt 235001 PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 E:\FR\FM\15JYN1.SGM 15JYN1

Agencies

[Federal Register Volume 80, Number 135 (Wednesday, July 15, 2015)]
[Notices]
[Pages 41506-41507]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-17248]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-0001]


Preparation for International Cooperation on Cosmetics Regulation

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of meeting.

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    The Food and Drug Administration (FDA or we) is announcing a public 
meeting entitled ``International Cooperation on Cosmetics Regulation 
(ICCR)--Preparation for ICCR-9 Meeting.'' The purpose of the meeting is 
to invite public input on various topics pertaining to the regulation 
of cosmetics. We may use this input to help us prepare for the ICCR-9 
meeting that will be held November 4-6, 2015, in Brussels, Belgium.
    Date and Time: The public meeting will be held on September 10, 
2015, from 2 p.m. to 4 p.m.
    Location: This meeting will be held at the Food and Drug 
Administration, Center for Food Safety and Applied Nutrition, 5100 
Paint Branch Pkwy., Wiley Auditorium (first floor), College Park, MD 
20740.
    Contact Person: Maria Rossana (Rosemary) Cook, Office of Cosmetics 
and Colors, Food and Drug Administration, 4300 River Rd., College Park, 
MD 20740, email: maria.cook@fda.hhs.gov, or FAX: 301-436-2975.
    Registration and Requests for Oral Presentations: Send registration 
information (including your name, title, firm name, address, telephone 
number, fax number, and email address), written material, and requests 
to make an oral presentation, to the contact person by August 27, 2015.
    If you need special accommodations due to a disability, please 
contact Maria Rossana (Rosemary) Cook by September 3, 2015.

SUPPLEMENTARY INFORMATION: You may present proposals for future ICCR 
agenda items, data, information, or views, orally or in writing, on 
issues pending at the public meeting. Time allotted for oral 
presentations may be limited to 10 minutes or less for each presenter. 
If you wish to make an oral presentation, you should notify the contact 
person by August 27, 2015, and submit a brief statement of the general 
nature of the evidence or arguments that you wish to present, your 
name, address, telephone number, fax number, and email address, and 
indicate the approximate amount of time you need to make your 
presentation.
    Transcripts: As soon as a transcript is available, it will be 
accessible at http://www.regulations.gov. It may also be viewed at the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20850. A transcript will 
also be available in either hardcopy or on CD-ROM, after submission of 
a Freedom of Information request. Written requests are to be sent to 
the Division of Freedom of Information, (ELEM-1029), Food and Drug 
Administration, 12420 Parklawn Dr., Element Bldg., Rockville, MD 20857.
    The Purpose of the Multilateral Framework on the ICCR: The purpose 
of the multilateral framework on the ICCR is to pave the way for the 
removal of regulatory obstacles to international trade while 
maintaining global consumer protection.

[[Page 41507]]

    ICCR is a voluntary international group of cosmetics regulatory 
authorities from the United States, Japan, the European Union, Canada, 
and Brazil. These regulatory authority members will enter into 
constructive dialogue with their relevant cosmetics industry trade 
associations and public advocacy groups. Currently, the ICCR members 
are: Health Canada; the European Commission Directorate-General for 
Internal Market, Industry, Entrepreneurship, and Subject Matter 
Experts; the Ministry of Health, Labor, and Welfare of Japan; the 
Brazilian Health Surveillance Agency; and FDA. All decisions made by 
consensus will be compatible with the laws, policies, rules, 
regulations, and directives of the respective administrations and 
governments. Members will implement and/or promote actions or documents 
within their own jurisdictions and seek convergence of regulatory 
policies and practices. Successful implementation will need input from 
stakeholders.
    Agenda: We will make the agenda for the public meeting available on 
the Internet at http://www.fda.gov/Cosmetics/InternationalActivities/ICCR/default.htm. Depending on the number of requests for oral 
presentations, we intend to have an agenda available by September 3, 
2015. We may use the information that you provide to us during the 
public meeting to help us prepare for the November 4-6, 2015, ICCR-9 
meeting.

    Dated: July 9, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-17248 Filed 7-14-15; 8:45 am]
BILLING CODE 4164-01-P