Impact of the Select Agent Regulations, 13639-13641 [2015-05906]

Download as PDF Federal Register / Vol. 80, No. 50 / Monday, March 16, 2015 / Notices contacting the identified DFO. Moreover, in view of the possibility that the schedule for ACRS meetings may be adjusted by the Chairman as necessary to facilitate the conduct of the meeting, persons planning to attend should check with these references if such rescheduling would result in a major inconvenience. If attending this meeting, please enter through the One White Flint North building, 11555 Rockville Pike, Rockville, MD. After registering with security, please contact Mr. Theron Brown (Telephone 240–888–9835) to be escorted to the meeting room. Dated: March 9, 2015. Mark L. Banks, Chief, Technical Support Branch, Advisory Committee on Reactor Safeguards. [FR Doc. 2015–05946 Filed 3–13–15; 8:45 am] BILLING CODE 7590–01–P NUCLEAR REGULATORY COMMISSION Advisory Committee on Reactor Safeguards (ACRS); Meeting of the ACRS Subcommittee on Fukushima; Notice of Meeting Rmajette on DSK2VPTVN1PROD with NOTICES The ACRS Subcommittee on Fukushima will hold a meeting on March 20, 2015, Room T–2B1, 11545 Rockville Pike, Rockville, Maryland. The meeting will be open to public attendance. The agenda for the subject meeting shall be as follows: Friday, March 20, 2015—8:30 a.m. Until 12:00 p.m. The Subcommittee will review and discuss the development of an Interim Staff Guidance in support of Order EA– 13–109, Reliable Hardened Vents, Phase 2. The Subcommittee will hear presentations by and hold discussions with the NRC staff and other interested persons regarding this matter. The Subcommittee will gather information, analyze relevant issues and facts, and formulate proposed positions and actions, as appropriate, for deliberation by the Full Committee. Members of the public desiring to provide oral statements and/or written comments should notify the Designated Federal Official (DFO), Weidong Wang (Telephone 301–415–6279 or Email: Weidong.Wang@nrc.gov) five days prior to the meeting, if possible, so that appropriate arrangements can be made. Thirty-five hard copies of each presentation or handout should be provided to the DFO thirty minutes before the meeting. In addition, one electronic copy of each presentation VerDate Sep<11>2014 14:09 Mar 13, 2015 Jkt 235001 should be emailed to the DFO one day before the meeting. If an electronic copy cannot be provided within this timeframe, presenters should provide the DFO with a CD containing each presentation at least thirty minutes before the meeting. Electronic recordings will be permitted only during those portions of the meeting that are open to the public. Detailed procedures for the conduct of and participation in ACRS meetings were published in the Federal Register on October 13, 2014, (79 FR 59307). Detailed meeting agendas and meeting transcripts are available on the NRC Web site at http://www.nrc.gov/readingrm/doc-collections/acrs. Information regarding topics to be discussed, changes to the agenda, whether the meeting has been canceled or rescheduled, and the time allotted to present oral statements can be obtained from the Web site cited above or by contacting the identified DFO. Moreover, in view of the possibility that the schedule for ACRS meetings may be adjusted by the Chairman as necessary to facilitate the conduct of the meeting, persons planning to attend should check with these references if such rescheduling would result in a major inconvenience. If attending this meeting, please enter through the One White Flint North building, 11555 Rockville Pike, Rockville, MD. After registering with security, please contact Mr. Theron Brown (Telephone 240–888–9835) to be escorted to the meeting room. 13639 hearing, and petition for leave to intervene; order, correction. The U.S. Nuclear Regulatory Commission (NRC) is correcting a notice that was published in the Federal Register on February 3, 2015, that contained an amendment request for Perry Nuclear Plant, Unit 1. This action is being taken to correct the date of the NRC’s Agencywide Documents Access and Management System (ADAMS) accession number for the amendment request from FirstEnergy Nuclear Operating Company. FOR FURTHER INFORMATION CONTACT: Eva A. Brown, Office of Nuclear Reactor Regulation, U.S. Nuclear Regulatory Commission, Washington, DC 20555– 0001; telephone: 301–415–2315; email: Eva.Brown@nrc.gov. SUPPLEMENTARY INFORMATION: In the Federal Register of February 3, 2015 (80 FR 5816), FR Doc. 2015–01917, on page 5819, in the middle of the second column, under ‘‘FirstEnergy Nuclear Operating Company, Docket No. 50– 440, Perry Nuclear Power Plant, Unit 1, Lake County, Perry Ohio,’’ after ‘‘Date of amendment request,’’ the date ‘‘September 12, 2014’’ is corrected to read ‘‘October 8, 2014.’’ SUMMARY: Dated in Rockville, Maryland, this 9th day of March, 2015. For the Nuclear Regulatory Commission. Eva A. Brown, Senior Project Manager, Plant Licensing III– 2 and Planning and Analysis Branch, Division of Operating Reactor Licensing, Office of Nuclear Reactor Regulation. Date: March 9, 2015. Mark L. Banks, Chief, Technical Support Branch, Advisory Committee on Reactor Safeguards. [FR Doc. 2015–05944 Filed 3–13–15; 8:45 am] [FR Doc. 2015–05988 Filed 3–13–15; 8:45 am] OFFICE OF SCIENCE AND TECHNOLOGY POLICY BILLING CODE 7590–01–P Impact of the Select Agent Regulations NUCLEAR REGULATORY COMMISSION ACTION: Applications and Amendments to Facility Operating Licenses and Combined Licenses Involving Proposed No Significant Hazards Considerations and Containing Sensitive Unclassified Non-Safeguards Information and Order Imposing Procedures for Access to Sensitive Unclassified Non-Safeguards Information; Corrections Nuclear Regulatory Commission. ACTION: License amendment request; opportunity to comment, request a AGENCY: Frm 00126 Fmt 4703 Request for Public Comment. Public comment is requested on the impact that the Select Agent Regulations have had on science, technology, and national security, and on the benefits, costs, and limitations of these regulations. Drawing on these comments and other information available to it, a Fast Track Action Committee under the Committee on Homeland and National Security of the National Science and Technology Council will review the impacts and consider options to address the identified challenges or gaps concerning those regulations. Comments of up to three pages or fewer (12,000 characters) are requested and must be received by SUMMARY: [NRC–2015–0007] PO 00000 BILLING CODE 7590–01–P Sfmt 4703 E:\FR\FM\16MRN1.SGM 16MRN1 13640 Federal Register / Vol. 80, No. 50 / Monday, March 16, 2015 / Notices 5:00 p.m. ET on March 30, 2015 to be considered. White House Memorandum for Enhancing Biosafety and Biosecurity Comments must be received by 5:00 p.m. ET on March 30, 2015 to be considered. Broad stakeholder engagement with respect to the impact of the SAR is one of the items called for in an August 18, 2014, White House memo on Enhancing Biosafety and Biosecurity in the United States, which outlined a series of immediate and longer-term steps the government would take to address the underlying causes of a series of biosafety incidents at U.S. government laboratories earlier that year. Though most of the actions were directed at federally funded laboratories, the Memo recognized that many stakeholders (e.g., regulators, regulated, or other parties interested in the SAR) could provide a broader, deeper understanding of the impact of the SAR. DATES: You may submit comments by any of the following methods: • Email: SAReview@hq.dhs.gov. Include ‘‘SAR Comments’’ in the subject line of the message. • Mail: Attn: Gerald L. Epstein, Ph.D., Co-Chair, Fast Track Action Committee, Deputy Assistant Secretary for Chemical, Biological, Radiological, and Nuclear Policy, U.S. Department of Homeland Security, 245 Murray Lane SW., Mail Stop #0315, Washington, DC 20528. Please allow sufficient time for security processing of postal mail. Instructions: Response to this request for public comment is voluntary. Responses exceeding 12,000 characters or three pages will not be considered. Submission via email is preferred. Responses to this request for public comment may be posted online. The Office of Science and Technology Policy (OSTP) therefore requests that no business proprietary information, copyrighted information, or sensitive personally identifiable information be submitted in response to this request. Please note that the U.S. Government will not pay for response preparation, or for the use of any information contained in the response. ADDRESSES: FOR FURTHER INFORMATION CONTACT: Gerald Epstein, Co-Chair, Fast Track Action Committee, at SAReview@ hq.dhs.gov, (202) 282–9078. This request for public comment offers the opportunity for interested individuals and organizations to comment on the impact that the Select Agent Regulations (SAR) have had on science, technology, and national security, and on the benefits, costs, and limitations of these regulations. The SAR (7 CFR part 331,9 CFR part 121, and 42 CFR part 73, http://www.selectagents.gov/ regulations.html) address the possession, use, and transfer of biological select agents and toxins— those agents and toxins that have been determined by the Secretary of Health and Human Services (HHS) or the Secretary of Agriculture as having the potential to pose a severe threat to public, animal or plant health or to animal or plant products. It is important that biological select agents and toxins are regulated in a way that effectively allows for research and development to enhance science, health, and national security. Rmajette on DSK2VPTVN1PROD with NOTICES SUPPLEMENTARY INFORMATION: VerDate Sep<11>2014 14:09 Mar 13, 2015 Jkt 235001 Questions Regarding the Select Agent and Toxin Regulations We invite comments on any aspect of the SAR. Comments are sought that identify concrete impacts and/or propose recommendations to ameliorate or resolve identified challenges or gaps. We welcome comments that separately address the implementation of the SAR (including the costs, benefits and impacts of implementation), the regulations themselves, and any broader issues pertaining to the safety and security of potentially dangerous biological microorganisms and toxins. While all comments are welcome, the following questions may help you frame your response: 1. What are the specific benefits, challenges, and impacts in implementing the SAR with respect to: (1) Scientific research (e.g., quality, breadth, international competitiveness, or other outcomes or consequences)?; (2) safety and security (e.g., biocontainment, biosafety, physical security, cybersecurity, and personnel suitability)?; and, 3. public or agricultural health and response (e.g. ability to respond rapidly and effectively to incidents and the development/availability of medical countermeasures)? 2. What gaps exist in the SAR (e.g., reporting, aggregated data collection, ability to transfer material across international borders) and what specific recommendations would fill those gaps? 3. Are facilities that possess, use, or transfer biological select agents and toxins in the U.S. safer than they were before the SAR went into effect in close to its current form in 2003? If so, to what extent are the SAR responsible? 4. The SAR strike a balance between avoiding harm (e.g., preventing safety or security lapses) and seeking benefits PO 00000 Frm 00127 Fmt 4703 Sfmt 4703 (e.g., conducting research and public or agricultural health activities). Do you think that balance has been struck appropriately? If not, what specific aspects of the SAR should be emphasized more, and what should be emphasized less? 5. Have the regulations unduly impaired research and other applications of select agents and toxins? If so, how? Please provide examples as appropriate, with specific sections of the SAR if possible. 6. If the SAR have unduly impaired research, how can the research and other applications be further promoted, while still protecting against misuse and accidental release? Please provide examples as appropriate, with specific aspects of the SAR if possible. 7. Have the regulations sufficiently protected public and agricultural health and safety against the misuse and accidental release of these agents? If so, or if not, how? Please provide examples as appropriate, with specific sections of the SAR if possible. 8. If the SAR are not sufficient for health and safety protection, how can health and safety be better protected while still facilitating legitimate use of select agents and toxins? Please provide recommended changes to the specific sections of the SAR if appropriate. 9. Describe how the overall costs of the SAR are or are not appropriately balanced with their overall benefits. 10. The SAR regulate the use, transfer, or possession of a specific list of potentially dangerous pathogens and toxins. Is designing the regulations around a list of agents advantageous or disadvantageous? If disadvantageous, in what other way can the regulations be organized and implemented? 11. Research today is a thoroughly international activity, with scientists and research materials constantly crossing national borders. Security threats today likewise extend across national borders. Are the SAR appropriately configured to accommodate these international issues? If not, how could they be improved? 12. Are the SAR appropriately configured to accommodate changes in science and technology such as, but not limited to, advances in synthetic biology, genetic engineering, or viral systematics? If not, how can they be reconfigured to better do so? What scientific and technical advances might E:\FR\FM\16MRN1.SGM 16MRN1 Federal Register / Vol. 80, No. 50 / Monday, March 16, 2015 / Notices improve the function or lessen the costs and burdens of the SAR? Ted Wackler, Deputy Chief of Staff and Assistant Director. [FR Doc. 2015–05906 Filed 3–13–15; 8:45 am] BILLING CODE 3710–F5–P SECURITIES AND EXCHANGE COMMISSION [Release No. 34–74460; File No. SR–Phlx– 2015–21] Self-Regulatory Organizations; NASDAQ OMX PHLX LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change Relating to Customer Rebate Program, Multiply Listed Options, PIXL Pricing March 10, 2015. Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (the ‘‘Act’’),1 and Rule 19b–4 thereunder,2 notice is hereby given that on February 26, 2015, NASDAQ OMX PHLX LLC (‘‘Phlx’’ or ‘‘Exchange’’) filed with the Securities and Exchange Commission (‘‘SEC’’ or ‘‘Commission’’) the proposed rule change as described in Items I, II, and III below, which Items have been prepared by the Exchange. The Commission is publishing this notice to solicit comments on the proposed rule change from interested persons. I. Self-Regulatory Organization’s Statement of the Terms of the Substance of the Proposed Rule Change The Exchange proposes to modify the Phlx Pricing Schedule (‘‘Pricing Schedule’’). Specifically, the Exchange proposes to amend pricing in Section B, entitled ‘‘Customer Rebate Program,’’ Section II, entitled ‘‘Multiply Listed Options Fees,’’ 3 and Section IV, Part A, entitled ‘‘PIXL Pricing,’’ 4 of the Pricing Schedule. The Exchange proposes these amendments in order to: (i) Establish a cap on rebates specifically for electronic Simple PIXL and Complex 5 PIXL 1 15 U.S.C. 78s(b)(1). CFR 240.19b–4. 3 This includes options overlying equities, exchange traded funds (‘‘ETFs’’), exchange traded notes (‘‘ETNs’’) and indexes which are Multiply Listed. 4 PIXLSM is the Exchange’s price improvement mechanism known as Price Improvement XL or PIXL. See Rule 1080(n). 5 A Complex Order is any order involving the simultaneous purchase and/or sale of two or more different options series in the same underlying security, priced at a net debit or credit based on the relative prices of the individual components, for the same account, for the purpose of executing a particular investment strategy. Furthermore, a Complex Order can also be a stock-option order, which is an order to buy or sell a stated number of units of an underlying stock or ETF coupled with Rmajette on DSK2VPTVN1PROD with NOTICES 2 17 VerDate Sep<11>2014 14:09 Mar 13, 2015 Jkt 235001 Orders and not pay rebates when electronic 6 Customer 7 Complex PIXL Orders execute against electronic Complex PIXL Initiating Orders; (ii) increase the assessment of fees for electronic Firm 8 Simple Orders underlying options in AAPL, BAC, EEM, FB, FXI, IWM, QQQ, TWTR, VXX and XLF; 9 (iii) increase the assessment of fees for electronic Complex Orders for Professionals,10 Firms and BrokerDealers; 11 (iv) increase the assessment of fees for adding liquidity in Penny Pilot Options 12 for Specialists 13 and Market Makers; 14 (v) clarify that the fee for Specialists and Market Makers that have reached their Monthly Market the purchase or sale of options contract(s). See Exchange Rule 1080, Commentary .08(a)(i) [sic]. 6 A transaction resulting from an order that was electronically delivered utilizes Phlx XL. See Exchange Rules 1014 and 1080. Electronically delivered orders do not include orders transacted on the Exchange floor. A transaction resulting from an order that is non-electronically-delivered is represented on the trading floor by a floor broker. See Exchange Rule 1063. All orders will be either electronically or non-electronically delivered. 7 The term ‘‘Customer’’ defines a person or entity that is neither a broker-dealer nor a direct or indirect affiliate of a broker-dealer, and includes a ‘‘Professional’’ as defined in Rule 1000(b)(14). See Securities Exchange Act Release Nos. 66755 (April 6, 2012), 77 FR 22037 (April 12, 2012) (SR–Phlx– 2012–42) (notice of filing and immediate effectiveness). 8 The term ‘‘Firm’’ applies to any transaction that is identified by a member or member organization for clearing in the Firm range at The Options Clearing Corporation. 9 AAPL, BAC, EEM, FB, FXI, IWM, QQQ, TWTR, VXX and XLF are currently Penny Pilot options (together ‘‘certain Penny Options’’). The $ 0.27 per contract pricing proposed herein is symbol-specific and will continue to apply to these symbols whether or not they are deleted from or added to the Penny Pilot. 10 The term ‘‘Professional’’ means any person or entity that (i) is not a broker or dealer in securities, and (ii) places more than 390 orders in listed options per day on average during a calendar month for its own beneficial account(s). See Rule 1000(b)(14). 11 The term ‘‘Broker-Dealer’’ applies to any transaction which is not subject to any of the other transaction fees applicable within a particular category. 12 The Penny Pilot was established in January 2007 and was last extended in 2014. See Securities Exchange Act Release Nos. 55153 (January 23, 2007), 72 FR 4553 (January 31, 2007) (SR–Phlx– 2006–74) (notice of filing and approval order establishing Penny Pilot); and 73688 (November 25, 2014), 79 FR 71484 (December 2, 2014) (SR–Phlx– 2014–77) (notice of filing and immediate effectiveness extending the Penny Pilot through June 30, 2015). All Penny Pilot Options listed on the Exchange can be found at http:// www.nasdaqtrader.com/Micro.aspx?id=phlx. 13 A Specialist is an Exchange member who is registered as an options specialist pursuant to Rule 1020(a). 14 A ‘‘Market Maker’’ includes Registered Options Traders (Rule 1014(b)(i) and (ii)), which includes Streaming Quote Traders (see Rule 1014(b)(ii)(A)) and Remote Streaming Quote Traders (see Rule 1014(b)(ii)(B)). Directed Participants are also market makers. PO 00000 Frm 00128 Fmt 4703 Sfmt 4703 13641 Maker Cap 15 in a non-complex electronic auction will include transactions which execute against an order for which the Exchange broadcast an order exposure alert; (vi) amend the Initiating Order Fee for Simple PIXL and Complex PIXL Initiating Orders; and (vii) amend the requirements to receive the PIXL Initiating Order Fee discount to require a member or member organization under Common Ownership 16 to qualify for a Tier 4 or Tier 5 Customer Rebate in Section B of the Pricing Schedule. The text of the proposed rule change is available on the Exchange’s Web site at http:// nasdaqomxphlx.cchwallstreet.com/, at the principal office of the Exchange, and at the Commission’s Public Reference Room. II. Self-Regulatory Organization’s Statement of the Purpose of, and Statutory Basis for, the Proposed Rule Change In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements. A. Self-Regulatory Organization’s Statement of the Purpose of, and Statutory Basis for, the Proposed Rule Change 1. Purpose The purpose of this filing is to modify the Pricing Schedule to specifically amend fees in Section B, entitled ‘‘Customer Rebate Program,’’ Section II, entitled ‘‘Multiply Listed Options Fees,’’ and Section IV, Part A, entitled ‘‘PIXL Pricing.’’ The Exchange proposes 15 Specialists and Market Makers are subject to a ‘‘Monthly Market Maker Cap’’ of $500,000 for: (i) Electronic and floor Option Transaction Charges; (ii) QCC Transaction Fees (as defined in Exchange Rule 1080(o) and Floor QCC Orders, as defined in 1064(e)); and (iii) fees related to an order or quote that is contra to a PIXL Order or specifically responding to a PIXL auction [sic]. The trading activity of separate Specialist and Market Maker member organizations is aggregated in calculating the Monthly Market Maker Cap if there is Common Ownership between the member organizations. All dividend, merger, short stock interest, reversal and conversion, jelly roll and box spread strategy executions (as defined in Section II) are excluded from the Monthly Market Maker Cap. 16 The term ‘‘Common Ownership’’ shall mean members or member organizations under 75% common ownership or control. E:\FR\FM\16MRN1.SGM 16MRN1

Agencies

[Federal Register Volume 80, Number 50 (Monday, March 16, 2015)]
[Notices]
[Pages 13639-13641]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-05906]


=======================================================================
-----------------------------------------------------------------------

OFFICE OF SCIENCE AND TECHNOLOGY POLICY


Impact of the Select Agent Regulations

ACTION: Request for Public Comment.

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

SUMMARY: Public comment is requested on the impact that the Select 
Agent Regulations have had on science, technology, and national 
security, and on the benefits, costs, and limitations of these 
regulations. Drawing on these comments and other information available 
to it, a Fast Track Action Committee under the Committee on Homeland 
and National Security of the National Science and Technology Council 
will review the impacts and consider options to address the identified 
challenges or gaps concerning those regulations. Comments of up to 
three pages or fewer (12,000 characters) are requested and must be 
received by

[[Page 13640]]

5:00 p.m. ET on March 30, 2015 to be considered.

DATES: Comments must be received by 5:00 p.m. ET on March 30, 2015 to 
be considered.

ADDRESSES: You may submit comments by any of the following methods:
     Email: SAReview@hq.dhs.gov. Include ``SAR Comments'' in 
the subject line of the message.
     Mail: Attn: Gerald L. Epstein, Ph.D., Co-Chair, Fast Track 
Action Committee, Deputy Assistant Secretary for Chemical, Biological, 
Radiological, and Nuclear Policy, U.S. Department of Homeland Security, 
245 Murray Lane SW., Mail Stop #0315, Washington, DC 20528. Please 
allow sufficient time for security processing of postal mail.
    Instructions: Response to this request for public comment is 
voluntary. Responses exceeding 12,000 characters or three pages will 
not be considered. Submission via email is preferred. Responses to this 
request for public comment may be posted online. The Office of Science 
and Technology Policy (OSTP) therefore requests that no business 
proprietary information, copyrighted information, or sensitive 
personally identifiable information be submitted in response to this 
request. Please note that the U.S. Government will not pay for response 
preparation, or for the use of any information contained in the 
response.

FOR FURTHER INFORMATION CONTACT: Gerald Epstein, Co-Chair, Fast Track 
Action Committee, at SAReview@hq.dhs.gov, (202) 282-9078.

SUPPLEMENTARY INFORMATION: This request for public comment offers the 
opportunity for interested individuals and organizations to comment on 
the impact that the Select Agent Regulations (SAR) have had on science, 
technology, and national security, and on the benefits, costs, and 
limitations of these regulations. The SAR (7 CFR part 331,9 CFR part 
121, and 42 CFR part 73, http://www.selectagents.gov/regulations.html) 
address the possession, use, and transfer of biological select agents 
and toxins--those agents and toxins that have been determined by the 
Secretary of Health and Human Services (HHS) or the Secretary of 
Agriculture as having the potential to pose a severe threat to public, 
animal or plant health or to animal or plant products. It is important 
that biological select agents and toxins are regulated in a way that 
effectively allows for research and development to enhance science, 
health, and national security.

White House Memorandum for Enhancing Biosafety and Biosecurity

    Broad stakeholder engagement with respect to the impact of the SAR 
is one of the items called for in an August 18, 2014, White House memo 
on Enhancing Biosafety and Biosecurity in the United States, which 
outlined a series of immediate and longer-term steps the government 
would take to address the underlying causes of a series of biosafety 
incidents at U.S. government laboratories earlier that year. Though 
most of the actions were directed at federally funded laboratories, the 
Memo recognized that many stakeholders (e.g., regulators, regulated, or 
other parties interested in the SAR) could provide a broader, deeper 
understanding of the impact of the SAR.

Questions Regarding the Select Agent and Toxin Regulations

    We invite comments on any aspect of the SAR. Comments are sought 
that identify concrete impacts and/or propose recommendations to 
ameliorate or resolve identified challenges or gaps. We welcome 
comments that separately address the implementation of the SAR 
(including the costs, benefits and impacts of implementation), the 
regulations themselves, and any broader issues pertaining to the safety 
and security of potentially dangerous biological microorganisms and 
toxins.
    While all comments are welcome, the following questions may help 
you frame your response:
    1. What are the specific benefits, challenges, and impacts in 
implementing the SAR with respect to: (1) Scientific research (e.g., 
quality, breadth, international competitiveness, or other outcomes or 
consequences)?; (2) safety and security (e.g., biocontainment, 
biosafety, physical security, cybersecurity, and personnel 
suitability)?; and, 3. public or agricultural health and response (e.g. 
ability to respond rapidly and effectively to incidents and the 
development/availability of medical countermeasures)?
    2. What gaps exist in the SAR (e.g., reporting, aggregated data 
collection, ability to transfer material across international borders) 
and what specific recommendations would fill those gaps?
    3. Are facilities that possess, use, or transfer biological select 
agents and toxins in the U.S. safer than they were before the SAR went 
into effect in close to its current form in 2003? If so, to what extent 
are the SAR responsible?
    4. The SAR strike a balance between avoiding harm (e.g., preventing 
safety or security lapses) and seeking benefits (e.g., conducting 
research and public or agricultural health activities). Do you think 
that balance has been struck appropriately? If not, what specific 
aspects of the SAR should be emphasized more, and what should be 
emphasized less?
    5. Have the regulations unduly impaired research and other 
applications of select agents and toxins? If so, how? Please provide 
examples as appropriate, with specific sections of the SAR if possible.
    6. If the SAR have unduly impaired research, how can the research 
and other applications be further promoted, while still protecting 
against misuse and accidental release? Please provide examples as 
appropriate, with specific aspects of the SAR if possible.
    7. Have the regulations sufficiently protected public and 
agricultural health and safety against the misuse and accidental 
release of these agents? If so, or if not, how? Please provide examples 
as appropriate, with specific sections of the SAR if possible.
    8. If the SAR are not sufficient for health and safety protection, 
how can health and safety be better protected while still facilitating 
legitimate use of select agents and toxins? Please provide recommended 
changes to the specific sections of the SAR if appropriate.
    9. Describe how the overall costs of the SAR are or are not 
appropriately balanced with their overall benefits.
    10. The SAR regulate the use, transfer, or possession of a specific 
list of potentially dangerous pathogens and toxins. Is designing the 
regulations around a list of agents advantageous or disadvantageous? If 
disadvantageous, in what other way can the regulations be organized and 
implemented?
    11. Research today is a thoroughly international activity, with 
scientists and research materials constantly crossing national borders. 
Security threats today likewise extend across national borders. Are the 
SAR appropriately configured to accommodate these international issues? 
If not, how could they be improved?
    12. Are the SAR appropriately configured to accommodate changes in 
science and technology such as, but not limited to, advances in 
synthetic biology, genetic engineering, or viral systematics? If not, 
how can they be reconfigured to better do so? What scientific and 
technical advances might

[[Page 13641]]

improve the function or lessen the costs and burdens of the SAR?

Ted Wackler,
Deputy Chief of Staff and Assistant Director.
[FR Doc. 2015-05906 Filed 3-13-15; 8:45 am]
BILLING CODE 3710-F5-P