80 FR 62538 - Clarifying Current Roles and Responsibilities Described in the Coordinated Framework for the Regulation of Biotechnology and Developing a Long-Term Strategy for the Regulation of the Products of Biotechnology; Public Meeting
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 200 (October 16, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 200 (October 16, 2015)
| Page Range | 62538-62541 | |
| FR Document | 2015-26311 |
[Federal Register Volume 80, Number 200 (Friday, October 16, 2015)] [Notices] [Pages 62538-62541] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-26311] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-N-3403] Clarifying Current Roles and Responsibilities Described in the Coordinated Framework for the Regulation of Biotechnology and Developing a Long-Term Strategy for the Regulation of the Products of Biotechnology; Public Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public meeting. ----------------------------------------------------------------------- SUMMARY: Under the auspices of the National Science and Technology Council, the Food and Drug Administration (FDA or the Agency), along with the Office of Science and Technology Policy (OSTP), the Environmental Protection Agency (EPA), and the United States Department of Agriculture (USDA), is announcing a public meeting, to be held on October 30, 2015, to discuss the memorandum entitled, ``Modernizing the Regulatory System for Biotechnology Products,'' issued by the Executive Office of the President (EOP) in July 2015. The purpose of the meeting is to inform the public about the activities described in the July 2015 memorandum; invite oral comments from interested parties; and provide information about how to submit written comments, data, or other information to the docket. DATES: See section II, ``How to Participate in the Public Meeting'' in the SUPPLEMENTARY INFORMATION section of this document for the date and time of the public meeting, closing dates for advance registration, and information on deadlines for submitting either electronic or written comments to FDA's Division of Dockets Management. Comments may be submitted in writing until November 13, 2015. ADDRESSES: See section II, ``How to Participate in the Public Meeting'' in the SUPPLEMENTARY INFORMATION section of this document. [[Page 62539]] You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://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 http://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-2015-N-3403 for ``Clarifying Current Roles and Responsibilities Described in the Coordinated Framework for the Regulation of Biotechnology and Developing a Long-Term Strategy for the Regulation of the Products of Biotechnology; Public Meeting.'' Comments received will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at http://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 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 http://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. FOR FURTHER INFORMATION CONTACT: For general questions about the meeting, to request an opportunity to make an oral presentation at the public meeting, to submit the full text or summary of an oral presentation, or for special accommodations due to a disability, contact the Office of Policy, Office of the Commissioner, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301- 796-4830, email: [email protected]. For questions about the memorandum entitled, ``Modernizing the Regulatory System for Biotechnology Products,'' or related activities described in that memorandum, contact the National Science and Technology Council: Emerging Technologies Interagency Policy Coordination Committee, Office of Science and Technology Policy, Executive Office of the President, Eisenhower Executive Office Building, 1650 Pennsylvania Ave., Washington DC 20504, 202-456-4444, online: https://www.whitehouse.gov/webform/contact-emerging-technologies-interagency-policy-coordinating-committee-national-science-and. SUPPLEMENTARY INFORMATION: I. Background In 1986, OSTP issued the Coordinated Framework for Regulation of Biotechnology (CF), which outlined a comprehensive Federal regulatory policy for ensuring the safety of biotechnology products. The CF sought to achieve a balance between regulation adequate to ensure the protection of health and the environment while maintaining sufficient regulatory flexibility to avoid impeding innovation (51 FR 23302; June 26, 1986) (Ref. 1). In 1992, OSTP issued an update to the CF that set forth a risk- based, scientifically sound basis for the oversight of activities that introduce biotechnology products into the environment (57 FR 6753; February 27, 1992) (Ref. 2). The update affirmed that Federal oversight should focus on the characteristics of the product, the environment into which it is being introduced, and the intended use of the product, rather than the process by which the product is created. On July 2, 2015, the EOP issued a memorandum entitled, ``Modernizing the Regulatory System for Biotechnology Products,'' (the EOP memorandum) directing the primary federal Agencies that have oversight responsibilities for the products of biotechnology--EPA, FDA, and USDA--to update the CF to clarify current roles and responsibilities of the Agencies that regulate the products of biotechnology, develop a long-term strategy to ensure that the Federal biotechnology regulatory system is prepared for the future products of biotechnology, and commission an independent, expert analysis of the future landscape of biotechnology products (Ref. 3). These efforts will build on the regulatory principles described in the CF and the 1992 update to the CF. The EOP memorandum's objectives are to ensure public confidence in the regulatory system and to prevent unnecessary barriers to future innovation and competitiveness by improving the transparency, coordination, predictability, and efficiency of the regulation of biotechnology products while continuing to protect health and the environment. [[Page 62540]] The July 2, 2015, EOP memorandum stated that the update to the CF should clarify the current roles and responsibilities of the Agencies that regulate the products of biotechnology by accomplishing the following four objectives: 1. Clarifying which biotechnology product areas are within the authority and responsibility of each Agency. 2. Clarifying the roles that each Agency plays for different product areas, particularly for those product areas that fall within the responsibility of multiple agencies, and how those roles relate to each other in the course of a regulatory assessment. 3. Clarifying a standard mechanism for communication and, as appropriate, coordination among Agencies, while they perform their respective regulatory functions, and for identifying Agency designees responsible for this coordination function. 4. Clarifying the mechanism and timeline for regularly reviewing, and updating as appropriate, the CF to minimize delays, support innovation, protect health and the environment, and promote the public trust in the regulatory systems for biotechnology products. As noted in the EOP memorandum, ``biotechnology products'' refers to products developed through genetic engineering or the targeted or in vitro manipulation of genetic information of organisms, including plants, animals, and microbes. It also covers some of the products produced by such plants, animals, and microbes or their derived products as determined by existing statutes and regulations. Products such as human drugs and medical devices are not the focus of the activities described in the EOP memorandum. In addition, on October 6, 2015, OSTP issued a notice of request for information (RFI) to solicit data and information, including case studies, that can inform the development of the proposed update to the CF and the development of a long-term strategy consistent with the objectives described in the July 2, 2015, EOP memorandum (80 FR 60414). In addition to the RFI, the EOP noted that it will hold three public engagement sessions over the next 12 months (Ref. 4), and that the current update to the CF will undergo public notice and comment before it is finalized. This notice is announcing the first public engagement session. The purpose of this first public meeting is to inform the public about the activities described in the EOP memorandum; invite oral, stakeholder comments relevant to those activities; and provide information about how to submit written comments, data, or other information to the docket. At this public meeting, OSTP will provide an overview of the CF and the 1992 update to the CF, and discuss the activities described in the EOP memorandum. EPA, FDA, and USDA will provide an overview of their current approaches to regulating products of biotechnology. The agenda for this public meeting will be posted approximately 5 days before the meeting at: http://www.fda.gov/NewsEvents/MeetingsConferencesWorkshops/ucm463783.htm. II. How To Participate in the Public Meeting OSTP, EPA, FDA, and USDA (collectively referred to as ``we'' or ``us'') are holding the public meeting under the auspices of the National Science and Technology Council. The meeting will be held on October 30, 2015, in the White Oak Great Room, at FDA's White Oak Campus, Building 31 Conference Center, the Great Room (Rm. 1503 B&C), 10903 New Hampshire Ave., Silver Spring, MD 20993-002. Entrance for the public meeting participants (non-FDA employees) is through Building 1 where routine security check procedures will be performed. For parking and security information, please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm. Due to limited space and time, we encourage all persons who wish to attend the meeting to register early and in advance of the meeting. There is no fee to register for the public meeting, and registration will be on a first-come, first-served basis. Onsite registration will be accepted, as space permits, after all preregistered attendees are seated. Those requesting an opportunity to make an oral presentation during the time allotted for public comment at the meeting are asked to submit a request in advance and to provide information about any specific topic or issue to be addressed. There will not be an opportunity to display materials such as slide shows, videos, or other media during the meeting. If time permits, individuals or organizations that did not register in advance may be granted the opportunity to make an oral presentation. We would like to maximize the number of individuals who make a presentation at the meeting and will do our best to accommodate all persons who wish to make a presentation or express their opinions at the meeting. We encourage persons and groups who have similar interests to consolidate their information for presentation by a single representative. After reviewing the presentation requests, we will notify each participant before the meeting of the approximate start time of their presentation and of the amount of time allotted for the comment. While oral presentations from specific individuals and organizations will be necessarily limited due to time constraints during the public meeting, interested parties may submit electronic or written comments to the docket. All relevant data and documentation should be submitted with the comments to Docket No. FDA-2015-N-3403. Table 1 provides information on participation in the public meeting. Table 1--Information on Participation in the Public Meeting and on Submitting Comments to the Docket ---------------------------------------------------------------------------------------------------------------- Electronic Other Date address Address information ---------------------------------------------------------------------------------------------------------------- Public meeting............... October 30, 2015........... http:// FDA's White Oak www.fda.gov/ Campus, Food/NewsEvents/ Building 31 WorkshopsMeetin Conference gsConferences/ Center, the default.htm. Great Room (1503-B&C), 10903 New Hampshire Ave., Silver Spring, MD 20993-002. Deadline for registration.... October 21, 2015........... http:// We encourage you There is no www.fda.gov/ to use registration Food/NewsEvents/ electronic fee for the WorkshopsMeetin registration if public gsConferences/ possible \1\. meetings. Early default.htm. registration is Docket No. FDA- recommended 2015-N-3403. because seating is limited. [[Page 62541]] Request to make a public October 21, 2015........... http:// ................ Requests made on comment. www.fda.gov/ the day of the Food/NewsEvents/ meeting to make WorkshopsMeetin an oral gsConferences/ presentation default.htm. will be granted as time permits. Information on requests to make an oral presentation may be posted without change to http://www.regulations.gov, including any personal information provided. Request special October 21, 2015........... Email: Office of accommodations due to a BiotechnologyUp Policy, Office disability. [email protected] of the v. Commissioner, U.S. Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301- 796-4830. Closing date for written November 13, 2015.......... http:// See ADDRESSES comments. www.regulations above. .gov. ---------------------------------------------------------------------------------------------------------------- \1\ For questions about registering for the meeting, to register by phone, or to submit a notice of participation by mail, FAX or email, contact: Office of Policy, Office of the Commissioner, U.S. Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301-796-4830, email: [email protected]. III. Comments, Transcripts, and Recorded Video Information and data submitted voluntarily to us will become part of the administrative record for this activity, and will be accessible to the public at http://www.regulations.gov. The transcript of the proceedings from the public meeting will become part of the administrative record for this activity. Please be advised that as soon as a transcript is available, it will be accessible at http://www.regulations.gov and on FDA's Web site at: http://www.fda.gov/Food/NewsEvents/WorkshopsMeetingsConferences/default.htm. It may also be viewed at the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. 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, 5630 Fishers Lane, Rm. 1035, Rockville, MD 20857. Additionally, we will live webcast and record the public meeting. Once the recorded video is available, it will be accessible on FDA's Web site at: http://www.fda.gov/Food/NewsEvents/WorkshopsMeetingsConferences/default.htm. IV. References The following references have been placed on display in the Division of Dockets Management (see ADDRESSES) and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; they are also available electronically at http://www.regulations.gov. FDA has verified the Web site addresses as of the date this document publishes in the Federal Register, but Web sites are subject to change over time. 1. Executive Office of the President. Office of Science and Technology Policy. Coordinated Framework for Regulation of Biotechnology. 51 FR 23302, June 26, 1986. Available online at: http://www.aphis.usda.gov/brs/fedregister/coordinated_framework.pdf. 2. Executive Office of the President. Office of Science and Technology Policy. Exercise of Federal Oversight Within Scope of Statutory Authority: Planned Introductions of Biotechnology Products Into the Environment. 57 FR 6753, February 27, 1992. Available online at: https://www.whitehouse.gov/sites/default/files/microsites/ostp/57_fed_reg_6753__1992.pdf. 3. Executive Office of the President. Office of Science and Technology Policy, Office of Management and Budget, United States Trade Representative, and Council on Environmental Quality. Modernizing the Regulatory System for Biotechnology Products, July 2, 2015. Available online at: https://www.whitehouse.gov/sites/default/files/microsites/ostp/modernizing_the_reg_system_for_biotech_products_memo_final.pdf. 4. Executive Office of the President. Improving Transparency and Ensuring Continued Safety in Biotechnology, blog post, July 2, 2015. Available online at: https://www.whitehouse.gov/blog/2015/07/02/improving-transparency-and-ensuring-continued-safety-biotechnology. Dated: October 9, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-26311 Filed 10-15-15; 8:45 am] BILLING CODE 4164-01-P
![62538 Federal Register / Vol. 80, No. 200 / Friday, October 16, 2015 / Notices
Drug Administration, 10903 New reliable and more relevant toxicity data BiologicsBloodVaccines/
Hampshire Ave., Bldg. 71, Rm. 7212, were brought to the attention of the GuidanceCompliance
Silver Spring, MD 20993–0002, 301– group and the modified PDE could RegulatoryInformation/Guidances/
796–8377. result in a revision of the tables and list. default.htm.
SUPPLEMENTARY INFORMATION: In 1999, ICH instituted a Q3C Dated: October 9, 2015.
maintenance agreement and formed a
I. Background Leslie Kux,
maintenance EWG (Q3C EWG). The
In recent years, many important agreement provided for the revisitation Associate Commissioner for Policy.
initiatives have been undertaken by of solvent PDEs and allowed for minor [FR Doc. 2015–26361 Filed 10–15–15; 8:45 am]
regulatory authorities and industry changes to the tables and list that BILLING CODE 4164–01–P
associations to promote international include the existing PDEs. The
harmonization of regulatory agreement also provided that new
requirements. FDA has participated in solvents and PDEs could be added to the DEPARTMENT OF HEALTH AND
many meetings designed to enhance tables and list based on adequate HUMAN SERVICES
harmonization and is committed to toxicity data. In the Federal Register of
February 12, 2002 (67 FR 6542), FDA Food and Drug Administration
seeking scientifically based harmonized
technical procedures for pharmaceutical briefly described the process for
development. One of the goals of proposing future revisions to the PDE. [Docket No. FDA–2015–N–3403]
harmonization is to identify and then In the same notice, the Agency
Clarifying Current Roles and
reduce differences in technical announced its decision to delink the
Responsibilities Described in the
requirements for drug development tables and list from the Q3C guidance
and create a stand-alone document Coordinated Framework for the
among regulatory agencies.
ICH was organized to provide an entitled ‘‘Q3C: Tables and List’’ to Regulation of Biotechnology and
opportunity for tripartite harmonization facilitate making changes recommended Developing a Long-Term Strategy for
initiatives to be developed with input by ICH. the Regulation of the Products of
from both regulatory and industry In June 2015, the ICH Steering Biotechnology; Public Meeting
representatives. FDA also seeks input Committee agreed that draft AGENCY: Food and Drug Administration,
from consumer representatives and recommendations for a new PDE for the HHS.
others. ICH is concerned with residual solvent triethylamine and a
ACTION: Notice of public meeting.
harmonization of technical revised PDE for the residual solvent
requirements for the registration of methylisobutylketone should be made SUMMARY: Under the auspices of the
pharmaceutical products among three available for public comment. The draft National Science and Technology
regions: Europe, Japan, and North recommendations are the product of the Council, the Food and Drug
America. The eight ICH sponsors are the Quality Expert Working Group of the Administration (FDA or the Agency),
European Commission; the European ICH. Comments about this draft will be along with the Office of Science and
Federation of Pharmaceutical Industries considered by FDA and the Quality Technology Policy (OSTP), the
Associations; the Japanese Ministry of Expert Working Group. Environmental Protection Agency
Health, Labour, and Welfare; the The draft recommendations provide (EPA), and the United States
Japanese Pharmaceutical Manufacturers guidance on the new PDE for the solvent Department of Agriculture (USDA), is
Association; CDER and CBER, FDA; the trimethylamine and the revised PDE for announcing a public meeting, to be held
Pharmaceutical Research and the solvent methylisobutylketone. In on October 30, 2015, to discuss the
Manufacturers of America; Health addition, the data used to derive the memorandum entitled, ‘‘Modernizing
Canada; and Swissmedic. The ICH PDEs are summarized. The document is the Regulatory System for
Secretariat, which coordinates the intended to recommend acceptable Biotechnology Products,’’ issued by the
preparation of documentation, is amounts for the listed residual solvents Executive Office of the President (EOP)
provided by the International in pharmaceuticals for the safety of the in July 2015. The purpose of the
Federation of Pharmaceutical patient. meeting is to inform the public about
Manufacturers Associations (IFPMA). The draft recommendations are being the activities described in the July 2015
The ICH Steering Committee includes issued consistent with FDA’s good memorandum; invite oral comments
representatives from each of the ICH guidance practices regulation (21 CFR from interested parties; and provide
sponsors and the IFPMA, as well as 10.115). The draft recommendations for information about how to submit
observers from the World Health the solvents trimethylamine and written comments, data, or other
Organization. methylisobutylketone, when finalized,
In the Federal Register of December information to the docket.
will represent the current thinking of
24, 1997 (62 FR 67377), FDA published DATES: See section II, ‘‘How to
FDA on this topic. They do not establish
the ICH guidance for industry entitled any rights for any person and are not Participate in the Public Meeting’’ in the
‘‘Q3C Impurities: Residual Solvents.’’ SUPPLEMENTARY INFORMATION section of
binding on FDA or the public. You can
The guidance makes recommendations use an alternative approach if it satisfies this document for the date and time of
as to what amounts of residual solvents the requirements of the applicable the public meeting, closing dates for
are considered to be toxicologically statutes and regulations. advance registration, and information
acceptable for some residual solvents. on deadlines for submitting either
Upon issuance in 1997, the text and II. Electronic Access electronic or written comments to FDA’s
srobinson on DSK5SPTVN1PROD with NOTICES
appendix 1 of the guidance contained Persons with access to the Internet Division of Dockets Management.
several tables and a list of solvents may obtain the document at http:// Comments may be submitted in writing
categorizing residual solvents by www.regulations.gov, http:// until November 13, 2015.
toxicity, classes 1 through 3, with class www.fda.gov/Drugs/ ADDRESSES: See section II, ‘‘How to
1 being the most toxic. The ICH Quality GuidanceCompliance Participate in the Public Meeting’’ in the
Expert Working Group (EWG) agreed RegulatoryInformation/Guidances/ SUPPLEMENTARY INFORMATION section of
that the PDE could be modified if default.htm, or http://www.fda.gov/ this document.
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![Federal Register / Vol. 80, No. 200 / Friday, October 16, 2015 / Notices 62541
TABLE 1—INFORMATION ON PARTICIPATION IN THE PUBLIC MEETING AND ON SUBMITTING COMMENTS TO THE DOCKET—
Continued
Date Electronic address Address Other information
Request to make a October 21, 2015 ...... http://www.fda.gov/Food/News ................................................. Requests made on the day of
public comment. Events/WorkshopsMeetings the meeting to make an oral
Conferences/default.htm. presentation will be granted
as time permits. Information
on requests to make an oral
presentation may be posted
without change to http://
www.regulations.gov, in-
cluding any personal infor-
mation provided.
Request special ac- October 21, 2015 ...... Email: BiotechnologyUpdate@ Office of Policy, Office of the
commodations due fda.hhs.gov. Commissioner, U.S. Food
to a disability. and Drug Administration,
10903 New Hampshire
Ave., Silver Spring, MD
20993, 301–796–4830.
Closing date for writ- November 13, 2015 .. http://www.regulations.gov ...... See ADDRESSES above.
ten comments.
1 For questions about registering for the meeting, to register by phone, or to submit a notice of participation by mail, FAX or email, contact: Of-
fice of Policy, Office of the Commissioner, U.S. Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301–796–
4830, email: BiotechnologyUpdate@fda.hhs.gov.
III. Comments, Transcripts, and also available electronically at http:// Dated: October 9, 2015.
Recorded Video www.regulations.gov. FDA has verified Leslie Kux,
Information and data submitted the Web site addresses as of the date Associate Commissioner for Policy.
voluntarily to us will become part of the this document publishes in the Federal [FR Doc. 2015–26311 Filed 10–15–15; 8:45 am]
administrative record for this activity, Register, but Web sites are subject to BILLING CODE 4164–01–P
and will be accessible to the public at change over time.
http://www.regulations.gov. The 1. Executive Office of the President. Office of
transcript of the proceedings from the Science and Technology Policy.
DEPARTMENT OF HEALTH AND
public meeting will become part of the Coordinated Framework for Regulation
HUMAN SERVICES
administrative record for this activity. of Biotechnology. 51 FR 23302, June 26,
Please be advised that as soon as a National Institutes of Health
1986. Available online at: http://
transcript is available, it will be www.aphis.usda.gov/brs/fedregister/ Proposed Collection; 60-day Comment
accessible at http://www.regulations.gov coordinated_framework.pdf. Request; Media-Smart Youth Leaders
and on FDA’s Web site at: http:// 2. Executive Office of the President. Office of Program (NICHD)
www.fda.gov/Food/NewsEvents/Work Science and Technology Policy. Exercise
shopsMeetingsConferences/default.htm. of Federal Oversight Within Scope of SUMMARY: In compliance with the
It may also be viewed at the Division of Statutory Authority: Planned requirement of Section 3506(c)(2)(A) of
Dockets Management (HFA–305), Food Introductions of Biotechnology Products the Paperwork Reduction Act of 1995,
and Drug Administration, 5630 Fishers Into the Environment. 57 FR 6753, for opportunity for public comment on
Lane, Rm. 1061, Rockville, MD 20852. A February 27, 1992. Available online at: proposed data collection projects, the
transcript will also be available in either https://www.whitehouse.gov/sites/ Eunice Kennedy Shriver National
hardcopy or on CD–ROM, after default/files/microsites/ostp/57_fed_reg_ Institute of Child Health and Human
submission of a Freedom of Information 6753__1992.pdf. Development (NICHD), National
request. Written requests are to be sent 3. Executive Office of the President. Office of Institutes of Health (NIH), will issue a
to the Division of Freedom of Science and Technology Policy, Office of funding announcement for the Media-
Information, 5630 Fishers Lane, Rm. Management and Budget, United States Smart Youth Leaders Program to the
1035, Rockville, MD 20857. Trade Representative, and Council on Office of Management and Budget
Additionally, we will live webcast and Environmental Quality. Modernizing the (OMB) for review and approval.
record the public meeting. Once the Regulatory System for Biotechnology Written comments and/or suggestions
recorded video is available, it will be Products, July 2, 2015. Available online from the public and affected agencies
accessible on FDA’s Web site at: http:// at: https://www.whitehouse.gov/sites/ are invited on one or more of the
www.fda.gov/Food/NewsEvents/ default/files/microsites/ostp/ following points: Whether the proposed
WorkshopsMeetingsConferences/ modernizing_the_reg_system_for_ collection of information is necessary
default.htm. biotech_products_memo_final.pdf. for the proper selection of facilitators to
4. Executive Office of the President. serve as local health educators, using
srobinson on DSK5SPTVN1PROD with NOTICES
IV. References Improving Transparency and Ensuring the Media-Smart Youth curriculum; the
The following references have been Continued Safety in Biotechnology, blog accuracy of the agency’s estimate of the
placed on display in the Division of post, July 2, 2015. Available online at: burden of the proposed collection of
Dockets Management (see ADDRESSES) https://www.whitehouse.gov/blog/2015/ information; ways to enhance the
and are available for viewing by 07/02/improving-transparency-and- quality, utility, and clarity of the
interested persons between 9 a.m. and 4 ensuring-continued-safety- information to be collected; and ways to
p.m., Monday through Friday; they are biotechnology. minimize the burden of the collection of
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Document Created: 2015-12-14 15:23:51
Document Modified: 2015-12-14 15:23:51
| 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 | Notices | |
| Action | Notice of public meeting. | |
| Dates | See section II, ``How to Participate in the Public Meeting'' in the SUPPLEMENTARY INFORMATION section of this document for the date and time of the public meeting, closing dates for advance registration, and information on deadlines for submitting either electronic or written comments to FDA's Division of Dockets Management. Comments may be submitted in writing until November 13, 2015. | |
| Contact | For general questions about the meeting, to request an opportunity to make an oral presentation at the public meeting, to submit the full text or summary of an oral presentation, or for special accommodations due to a disability, contact the Office of Policy, Office of the Commissioner, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301- 796-4830, email: [email protected] | |
| FR Citation | 80 FR 62538 |
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