80 FR 11208 - Announcement of Requirements and Registration for “A Wearable Alcohol Biosensor” Challenge
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health Federal Register Volume 80, Issue 40 (March 2, 2015)
National Institutes of Health
Federal Register Volume 80, Issue 40 (March 2, 2015)
| Page Range | 11208-11210 | |
| FR Document | 2015-04254 |
[Federal Register Volume 80, Number 40 (Monday, March 2, 2015)] [Notices] [Pages 11208-11210] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-04254] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Announcement of Requirements and Registration for ``A Wearable Alcohol Biosensor'' Challenge Authority: 15 U.S.C. 3719. Award Approving Official: Dr. Lawrence A. Tabak, Principal Deputy Director, National Institutes of Health (NIH). SUMMARY: Through the ``A Wearable Alcohol Biosensor'' Challenge (the ``Challenge''), the National Institute on Alcohol Abuse and Alcoholism (NIAAA), a component of the National Institutes of Health (NIH), is searching for a wearable or otherwise discreet device capable of measuring blood alcohol level in real time. The advent of alcohol biosensors that can be worn discreetly and used by individuals in the course of their daily lives will advance the mission of NIAAA in the arenas of research, treatment, and rehabilitation. NIAAA has supported academic and small business grants and contracts to advance the development and use of alcohol biosensors in the past. Current technological developments in electronics, miniaturization, wireless technology, and biophysical techniques of alcohol detection in humans increase the likelihood of successful development of a useful alcohol biosensor in the near future. The NIH believes that this challenge will stimulate investment from public and private sectors in the development of functional alcohol biosensors that will be appealing to individuals, treatment providers, and researchers. DATES: Submission period begins March 2, 2015, 9:00 a.m. ET. Submission period ends: December 1, 2015. Judging period: January 2016. Winners announced: On or after February 15, 2016. The NIH will announce any changes to this timeline by amending this Federal Register notice. FOR FURTHER INFORMATION CONTACT: M. Katherine Jung, Ph.D., Program Director, Division of Metabolism and Health Effects, National Institute on Alcohol Abuse and Alcoholism, Phone: 301-443-8744, Email Kathy.jung@nih.gov. F.L. Dammann, M.P.A., Management Analyst and Special Assistant to the Executive, National Institute on Alcohol Abuse and Alcoholism, Phone: 301-480-9433, Email: fl.dammann@nih.gov. SUPPLEMENTARY INFORMATION: Subject of Challenge Current technologies for real time monitoring of alcohol consumption, used in criminal justice applications, have performed adequately, but have disadvantages for broader use. NIAAA seeks the design and production of a wearable device to monitor blood alcohol levels in real time. The device should be inconspicuous, low profile, and appealing to the wearer. The design can take the form of jewelry, clothing, or any other format located in contact with the human body. A non-invasive technology is preferred. Current technology for continuous alcohol monitoring takes a reading every 30 minutes. We are seeking a solution that improves on this interval and most closely approximates real time monitoring and data collection. The device should be able to quantitate blood alcohol level, interpret and store the data, or transmit it to a smartphone or other device by wireless transmission. Data storage and transmission must be completely secure in order to protect the privacy of the individual. The device should have the ability to verify standardization at regular intervals and to indicate loss of functionality. The power source should be dependable and rechargeable. A form of subject identification would be an added benefit. The device can be removable. This is a reduction to practice challenge that requires written documentation and a working prototype of the submitted solution. NIAAA is open to a range of design forms which can accomplish the above tasks. Statutory Authority of the Funding Source This Challenge is consistent with and advances the mission of NIAAA, as described in 42 U.S.C. 285n, to conduct and support biomedical and behavioral research, health services research, research training, and health information dissemination with respect to the prevention of alcohol abuse and the treatment of alcoholism, and to conduct a study of alternative approaches for alcoholism and alcohol abuse treatment and rehabilitation. Eligibility Rules for the Challenge 1. To Participate This Challenge is open to any ``Solver'' where ``Solver'' is defined as an individual, a group of individuals (i.e., a team), or an entity. Whether singly or as part of a group or entity, individuals younger than 18 participating in the Challenge must provide parental consent and must abide by the Children's Online Privacy Protection Act. 2. To Win To be eligible to win a prize under this Challenge, the Solver-- 1. Shall have registered to participate in the Challenge at www.challenge.gov. 2. Shall have complied with all the requirements under this section on Eligibility. 3. In the case of a private entity, shall be incorporated in and maintain a primary place of business in the United States; and in the case of an individual, whether participating singly or in a group, shall be a citizen or permanent resident of the United States. Note: Non- U.S. citizens and nonpermanent residents can participate as a member of a team that otherwise satisfies the eligibility criteria but will not be eligible to win a monetary prize (in whole or in part); however, their participation as part of a winning team, if applicable, may be recognized when results are announced. 4. In the case of an individual, he/she may not be an employee of the NIH; an individual involved in formulation of the Challenge and/or serving on the technical evaluation panel; any other individual involved with the design, [[Page 11209]] production, execution, distribution, or evaluation of this Challenge; or members of the individual's immediate family (specifically, a parent, stepparent, spouse, domestic partner, child, sibling, or step- sibling). 5. An individual, team, or entity that is currently on the Excluded Parties List (https://www.epls.gov/) will not be selected as a Finalist or prize winner. 6. In the case of an entity, may not be a federal entity; and in the case of an individual, may not be a federal employee acting within the scope of his or her employment. 7. Federal employees otherwise permitted to participate in the Challenge shall not work on their submission during assigned duty hours. Note: Federal ethical conduct rules may restrict or prohibit federal employees from engaging in certain outside activities, so any federal employee not excluded under the prior paragraph seeking to participate in this Challenge outside the scope of employment should consult his/her agency's ethics official prior to developing a submission. 8. Federal grantees may not use federal funds to develop Challenge submissions. 9. Federal contractors may not use federal funds from a contract to develop Challenge submissions or to fund efforts in support of a Challenge submission. 10. An individual shall not be deemed ineligible to win because the individual used federal facilities or consulted with federal employees during the Challenge provided that such facilities and/or employees, as applicable, are made available on an equitable basis to all individuals and teams participating in the Challenge. All questions regarding the Challenge should be directed to Dr. Jung or Mr. Dammann, identified above, and answers will be posted and updated as necessary at http://www.niaaa.nih.gov/research/challenge-prize under Frequently Asked Questions. Questions from Solvers that may reveal proprietary information related to solutions under development addressed to NIAAA will be held in strictest confidence. Submission Requirements The submission to the Challenge should include the following: (1) The final solution set for challenge award must include reduction to practice of a working prototype of a wearable alcohol biosensor. (2) Solutions should also include written evidence of successful data storage and retrieval, of consistent function, reliability and robust reproducibility of alcohol quantification. A detailed description of the proposed Solution must include an instructive account of the method of alcohol detection, interval of data sampling, the means of subject identification, proposed process of manufacture, verification of data security and integrity, and standardization of measurements. (3) Image or images of the proposed wearable, to include overall dimensions. (4) A video demonstrating the wearable's required capabilities. Registration and Submission Process for Solvers Solvers must register and submit their Solutions on www.challenge.gov Web site under the link for ``A Wearable Alcohol Biosensor''. Amount of the Prize First Prize: $200,000 Second Prize: $100,000 The NIH reserves the right to cancel, suspend, and/or modify this Challenge at any time through amendment to this Federal Register notice. In addition, the NIH reserves the right to not award any prizes if no solutions are deemed worthy. The award approving official for this Challenge is the NIH Principal Deputy Director. Payment of the Prize Prizes awarded under this competition will be paid by electronic funds transfer and may be subject to Federal income taxes. NIAAA will comply with the Internal Revenue Service withholding and reporting requirements, where applicable. Basis Upon Which Winners Will Be Evaluated Submissions will be judged by a qualified panel selected by NIAAA. The panel will evaluate submissions based on the following judging criteria: 1. Accuracy, reliability, and frequency of blood alcohol measurement 2. Functionality, accuracy, and integration of data collection, data transmission and data storage 3. Safeguards for privacy protection and data integrity 4. Plans for process of manufacture 5. Marketability and likelihood of bringing the product to market 6. Appeal and acceptability to wearers 7. Feasibility The award is contingent upon experimental validation of the submitted Solution by the Seeker. During the judging period, the expert panel may request additional information or clarification in order to evaluate the entry. Challenge Judges Director, National Institute on Alcohol Abuse and Alcoholism A senior staff member from the National Institute of Biomedical Imaging and Bioengineering One or more members from the National Advisory Council of the National Institute on Alcohol Abuse and Alcoholism Program Staff from the National Institute on Alcohol Abuse and Alcoholism The challenge judges will be advised by a technical panel consisting of individuals with expertise in the following areas: Chemistry Engineering Information Technology and Information System Security Behavioral and Social Sciences Development of vehicular alcohol detection systems Additional Information Intellectual Property: By submitting the Submission, each Solver warrants that he or she is the sole author and owner of any patentable works that the Submission comprises, that the works are wholly original with the Solver (or is an improved version of an existing work that the Solver has sufficient rights to use and improve), and that the Submission does not infringe on any copyright, patent or any other rights of any third party of which Solver is aware. To receive an award, Solvers will not be required to transfer their exclusive intellectual property rights to the NIH. Instead, Solvers will grant to the federal government a nonexclusive license to practice their solutions and use the materials that describe them. To participate in the Challenge, each Solver must warrant that there are no legal obstacles to providing a nonexclusive license of Solver's rights to the federal government. This license will grant to the United States government a nonexclusive, nontransferable, irrevocable, paid-up license to practice or have practiced for or on behalf of the United States throughout the world any invention made by the Solvers that covers the Submission. In addition, the license will grant to the federal government and others acting on its behalf, a paid-up, nonexclusive, irrevocable, worldwide license in any copyrightable works that the Submission comprises, including the right to reproduce, prepare derivative works, distribute copies to the public, and perform publicly and display publicly said copyrightable works. [[Page 11210]] Liability and Indemnification: By participating in this Challenge, each Solver agrees to assume any and all risks and waive claims against the federal government and its related entities, except in the case of willful misconduct, for any injury, death, damage, or loss of property, revenue, or profits, whether direct, indirect, or consequential, arising from participation in this Challenge, whether the injury, death, damage, or loss arises through negligence or otherwise. By participating in this Challenge, each Solver agrees to indemnify the federal government against third party claims for damages arising from or related to Challenge activities. Insurance: Based on the subject matter of the Challenge, the type of work that it will possibly require, as well as an analysis of the likelihood of any claims for death, bodily injury, or property damage, or loss potentially resulting from competition participation. Solvers are not required to obtain liability insurance or demonstrate financial responsibility in order to participate in this Challenge. Privacy, Data Security, Ethics, and Compliance: Solvers are required to identify and address privacy and security issues in their proposed projects and describe specific solutions for meeting them. In addition to complying with appropriate policies, procedures, and protections for data that ensures all privacy requirements and institutional policies are met, use of data should not allow the identification of the individual from whom the data was collected. Solvers are responsible for compliance with all applicable federal, state, local, and institutional laws, regulations, and policies. These may include, but are not limited to, Health Information Portability and Accountability Act (HIPAA) protections, Department of Health and Human Services (HHS) Protection of Human Subjects regulations, and Food and Drug Administration (FDA) regulations. It is the responsibility of the Solver to obtain approvals (e.g., from an Institutional Review Board), if required. The following links are intended as a starting point for addressing regulatory requirements but should not be interpreted as a complete list of resources on these issues: HIPAA Main link: http://www.hhs.gov/ocr/privacy/index.html. Summary of the HIPAA Privacy Rule: http://www.hhs.gov/ocr/privacy/hipaa/understanding/summary/index.html. Summary of the HIPAA Security Rule: http://www.hhs.gov/ocr/privacy/hipaa/understanding/srsummary.html. Human Subjects--HHS Office for Human Research Protections: http://www.hhs.gov/ohrp/index.html. Protection of Human Subjects Regulations: http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html. Policy & Guidance: http://www.hhs.gov/ohrp/policy/index.html. Institutional Review Boards &Assurances: http://www.hhs.gov/ohrp/assurances/index.html. Human Subjects--FDA Clinical Trials: http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/default.htm. Office of Good Clinical Practice: http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/OfficeofScienceandHealthCoordination/ucm2018191. Consumer Protection--Federal Trade Commission Bureau of Consumer Protection: http://business.ftc.gov/privacy-and-security. Dated: February 23, 2015. Lawrence A. Tabak, Deputy Director, National Institutes of Health. [FR Doc. 2015-04254 Filed 2-27-15; 8:45 am] BILLING CODE 4140-01-P
![11208 Federal Register / Vol. 80, No. 40 / Monday, March 2, 2015 / Notices
collecting, validating and verifying a useful alcohol biosensor in the near added benefit. The device can be
information, processing and future. The NIH believes that this removable.
maintaining information, and disclosing challenge will stimulate investment This is a reduction to practice
and providing information; to train from public and private sectors in the challenge that requires written
personnel and to be able to respond to development of functional alcohol documentation and a working prototype
a collection of information, to search biosensors that will be appealing to of the submitted solution.
data sources, to complete and review individuals, treatment providers, and NIAAA is open to a range of design
the collection of information; and to researchers. forms which can accomplish the above
transmit or otherwise disclose the tasks.
DATES:
information.
All written comments will be Submission period begins March 2, Statutory Authority of the Funding
available for public inspection on 2015, 9:00 a.m. ET. Source
Regulations.gov. Submission period ends: December 1, This Challenge is consistent with and
An agency may not conduct or 2015. advances the mission of NIAAA, as
sponsor, and a person is not required to Judging period: January 2016. described in 42 U.S.C. 285n, to conduct
respond to, a collection of information Winners announced: On or after and support biomedical and behavioral
unless it displays a currently valid OMB February 15, 2016. research, health services research,
control number. The NIH will announce any changes research training, and health
Comment Due Date: Your comments to this timeline by amending this information dissemination with respect
regarding this information collection are Federal Register notice. to the prevention of alcohol abuse and
best assured of having full effect if FOR FURTHER INFORMATION CONTACT: M. the treatment of alcoholism, and to
received within 30 days of the date of Katherine Jung, Ph.D., Program Director, conduct a study of alternative
this publication. Division of Metabolism and Health approaches for alcoholism and alcohol
Dated: February 20, 2015. Effects, National Institute on Alcohol abuse treatment and rehabilitation.
Robert G. McSwain, Abuse and Alcoholism, Phone: 301–
Eligibility Rules for the Challenge
Acting Director, Indian Health Service. 443–8744, Email Kathy.jung@nih.gov.
[FR Doc. 2015–04112 Filed 2–27–15; 8:45 am]
F.L. Dammann, M.P.A., Management 1. To Participate
BILLING CODE 4165–16–P
Analyst and Special Assistant to the This Challenge is open to any
Executive, National Institute on Alcohol ‘‘Solver’’ where ‘‘Solver’’ is defined as
Abuse and Alcoholism, Phone: 301– an individual, a group of individuals
DEPARTMENT OF HEALTH AND 480–9433, Email: fl.dammann@nih.gov. (i.e., a team), or an entity. Whether
HUMAN SERVICES SUPPLEMENTARY INFORMATION: singly or as part of a group or entity,
Subject of Challenge individuals younger than 18
National Institutes of Health participating in the Challenge must
Current technologies for real time provide parental consent and must
Announcement of Requirements and monitoring of alcohol consumption, abide by the Children’s Online Privacy
Registration for ‘‘A Wearable Alcohol used in criminal justice applications, Protection Act.
Biosensor’’ Challenge have performed adequately, but have
disadvantages for broader use. 2. To Win
Authority: 15 U.S.C. 3719.
NIAAA seeks the design and To be eligible to win a prize under
Award Approving Official: Dr. production of a wearable device to this Challenge, the Solver—
Lawrence A. Tabak, Principal Deputy monitor blood alcohol levels in real 1. Shall have registered to participate
Director, National Institutes of Health time. The device should be in the Challenge at www.challenge.gov.
(NIH). inconspicuous, low profile, and 2. Shall have complied with all the
SUMMARY: Through the ‘‘A Wearable appealing to the wearer. The design can requirements under this section on
Alcohol Biosensor’’ Challenge (the take the form of jewelry, clothing, or any Eligibility.
‘‘Challenge’’), the National Institute on other format located in contact with the 3. In the case of a private entity, shall
Alcohol Abuse and Alcoholism human body. A non-invasive technology be incorporated in and maintain a
(NIAAA), a component of the National is preferred. primary place of business in the United
Institutes of Health (NIH), is searching Current technology for continuous States; and in the case of an individual,
for a wearable or otherwise discreet alcohol monitoring takes a reading every whether participating singly or in a
device capable of measuring blood 30 minutes. We are seeking a solution group, shall be a citizen or permanent
alcohol level in real time. The advent of that improves on this interval and most resident of the United States. Note: Non-
alcohol biosensors that can be worn closely approximates real time U.S. citizens and nonpermanent
discreetly and used by individuals in monitoring and data collection. The residents can participate as a member of
the course of their daily lives will device should be able to quantitate a team that otherwise satisfies the
advance the mission of NIAAA in the blood alcohol level, interpret and store eligibility criteria but will not be eligible
arenas of research, treatment, and the data, or transmit it to a smartphone to win a monetary prize (in whole or in
rehabilitation. NIAAA has supported or other device by wireless part); however, their participation as
academic and small business grants and transmission. Data storage and part of a winning team, if applicable,
asabaliauskas on DSK5VPTVN1PROD with NOTICES
contracts to advance the development transmission must be completely secure may be recognized when results are
and use of alcohol biosensors in the in order to protect the privacy of the announced.
past. Current technological individual. The device should have the 4. In the case of an individual, he/she
developments in electronics, ability to verify standardization at may not be an employee of the NIH; an
miniaturization, wireless technology, regular intervals and to indicate loss of individual involved in formulation of
and biophysical techniques of alcohol functionality. The power source should the Challenge and/or serving on the
detection in humans increase the be dependable and rechargeable. A form technical evaluation panel; any other
likelihood of successful development of of subject identification would be an individual involved with the design,
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![11210 Federal Register / Vol. 80, No. 40 / Monday, March 2, 2015 / Notices
Liability and Indemnification: By hipaa/understanding/summary/ 30 days for public comment. The Office
participating in this Challenge, each index.html. of the Director (OD), National Institutes
Solver agrees to assume any and all Summary of the HIPAA Security Rule: of Health, may not conduct or sponsor,
risks and waive claims against the http://www.hhs.gov/ocr/privacy/ and the respondent is not required to
federal government and its related hipaa/understanding/ respond to, an information collection
entities, except in the case of willful srsummary.html. that has been extended, revised, or
misconduct, for any injury, death, implemented on or after October 1,
Human Subjects—HHS
damage, or loss of property, revenue, or 1995, unless it displays a currently valid
profits, whether direct, indirect, or Office for Human Research Protections: OMB control number.
consequential, arising from http://www.hhs.gov/ohrp/index.html. Direct Comments to OMB: Written
participation in this Challenge, whether Protection of Human Subjects comments and/or suggestions regarding
the injury, death, damage, or loss arises Regulations: http://www.hhs.gov/ the item(s) contained in this notice,
through negligence or otherwise. By ohrp/humansubjects/guidance/ especially regarding the estimated
participating in this Challenge, each 45cfr46.html. public burden and associated response
Solver agrees to indemnify the federal Policy & Guidance: http://www.hhs.gov/ time, should be directed to the: Office
government against third party claims ohrp/policy/index.html. of Management and Budget, Office of
for damages arising from or related to Institutional Review Boards Regulatory Affairs, OIRA_submission@
Challenge activities. &Assurances: http://www.hhs.gov/ omb.eop.gov or by fax to 202–395–6974,
Insurance: Based on the subject ohrp/assurances/index.html. Attention: NIH Desk Officer.
matter of the Challenge, the type of
Human Subjects—FDA Comment Due Date: Comments
work that it will possibly require, as
well as an analysis of the likelihood of Clinical Trials: http://www.fda.gov/ regarding this information collection are
any claims for death, bodily injury, or ScienceResearch/SpecialTopics/ best assured of having their full effect if
property damage, or loss potentially RunningClinicalTrials/default.htm. received within 30-days of the date of
resulting from competition Office of Good Clinical Practice: this publication.
participation. Solvers are not required to http://www.fda.gov/AboutFDA/ FOR FURTHER INFORMATION CONTACT: To
obtain liability insurance or CentersOffices/ obtain a copy of the data collection
demonstrate financial responsibility in OfficeofMedicalProductsandTobacco/ plans and instruments or request more
order to participate in this Challenge. OfficeofScienceandHealthCoordination/ information on the proposed project
Privacy, Data Security, Ethics, and ucm2018191. contact: Ms. Sarah Carr, Acting Director,
Compliance: Solvers are required to Office of Clinical Research and
Consumer Protection—Federal Trade
identify and address privacy and Bioethics Policy, Office of Science
Commission
security issues in their proposed Policy, NIH, 6705 Rockledge Dr., Suite
projects and describe specific solutions Bureau of Consumer Protection: 750, Bethesda, MD 20892, or call non-
for meeting them. In addition to http://business.ftc.gov/privacy-and- toll-free number (301) 496–9838, or
complying with appropriate policies, security. Email your request, including your
procedures, and protections for data that Dated: February 23, 2015. address to: OCRBP-OSP@od.nih.gov.
ensures all privacy requirements and Lawrence A. Tabak, Formal requests for additional plans and
institutional policies are met, use of instruments must be requested in
Deputy Director, National Institutes of Health.
data should not allow the identification writing.
[FR Doc. 2015–04254 Filed 2–27–15; 8:45 am]
of the individual from whom the data Proposed Collection: The Genetic
was collected. Solvers are responsible BILLING CODE 4140–01–P
Testing Registry, 0925–0651,
for compliance with all applicable EXTENSION—Office of the Director
federal, state, local, and institutional (OD), National Institutes of Health
DEPARTMENT OF HEALTH AND
laws, regulations, and policies. These (NIH).
HUMAN SERVICES
may include, but are not limited to,
Health Information Portability and Need and Use of Information
National Institutes of Health Collection: Clinical laboratory tests are
Accountability Act (HIPAA) protections,
Department of Health and Human available for more than 5,000 genetic
Submission for OMB Review; 30-Day conditions. The Genetic Testing Registry
Services (HHS) Protection of Human Comment Request; The Genetic
Subjects regulations, and Food and Drug (GTR) provides a centralized, online
Testing Registry location for test developers,
Administration (FDA) regulations. It is
the responsibility of the Solver to obtain SUMMARY: Under the provisions of manufacturers, and researchers to
approvals (e.g., from an Institutional Section 3507(a)(1)(D) of the Paperwork voluntarily submit detailed information
Review Board), if required. The Reduction Act of 1995, the National about the availability and scientific
following links are intended as a Institutes of Health (NIH) has submitted basis of their genetic tests. The GTR is
starting point for addressing regulatory to the Office of Management and Budget of value to clinicians by providing
requirements but should not be (OMB) a request for review and information about the accuracy,
interpreted as a complete list of approval of the information collection validity, and usefulness of genetic tests.
resources on these issues: listed below. This proposed information The GTR also highlights evidence gaps
collection was previously published in where additional research is needed.
asabaliauskas on DSK5VPTVN1PROD with NOTICES
HIPAA the Federal Register on November 25, OMB approval is requested for 3
Main link: http://www.hhs.gov/ocr/ 2014, page 70194 and allowed 60 days years. There are no costs to respondents
privacy/index.html. for public comment. No public other than their time. The total
Summary of the HIPAA Privacy Rule: comments were received. The purpose estimated annualized burden hours are
http://www.hhs.gov/ocr/privacy/ of this notice is to allow an additional 5,536.
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Document Created: 2015-12-18 12:07:55
Document Modified: 2015-12-18 12:07:55
| 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 | |
| Dates | Submission period begins March 2, 2015, 9:00 a.m. ET. | |
| Contact | M. Katherine Jung, Ph.D., Program Director, Division of Metabolism and Health Effects, National Institute on Alcohol Abuse and Alcoholism, Phone: 301-443-8744, Email [email protected] F.L. Dammann, M.P.A., Management Analyst and Special Assistant to the Executive, National Institute on Alcohol Abuse and Alcoholism, Phone: 301-480-9433, Email: [email protected] | |
| FR Citation | 80 FR 11208 |
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