83_FR_35811 83 FR 35666 - National Institute of Neurological Disorders and Stroke, Muscular Dystrophy Coordinating Committee Call for Committee Membership Nominations

83 FR 35666 - National Institute of Neurological Disorders and Stroke, Muscular Dystrophy Coordinating Committee Call for Committee Membership Nominations

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 83, Issue 145 (July 27, 2018)

Page Range35666-35667
FR Document2018-16112

The Office of the Secretary of the Department of Health and Human Services (HHS) is seeking nominations for an individual to serve as a nonfederal public member on the Muscular Dystrophy Coordinating Committee.

Federal Register, Volume 83 Issue 145 (Friday, July 27, 2018) 
[Federal Register Volume 83, Number 145 (Friday, July 27, 2018)]
[Notices]
[Pages 35666-35667]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-16112]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Institute of Neurological Disorders and Stroke, Muscular 
Dystrophy Coordinating Committee Call for Committee Membership 
Nominations

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: The Office of the Secretary of the Department of Health and 
Human Services (HHS) is seeking nominations for an individual to serve 
as a nonfederal public member on the Muscular Dystrophy Coordinating 
Committee.

DATES: Nominations are due by 5 p.m. EDT on August 31, 2018.

ADDRESSES: Nominations must be sent to Glen Nuckolls, Ph.D., by email 
to nuckollg@ninds.nih.gov.

FOR FURTHER INFORMATION CONTACT: Glen Nuckolls, Ph.D., by email to 
nuckollg@ninds.nih.gov. or (301) 496-5745.

SUPPLEMENTARY INFORMATION: The Muscular Dystrophy Coordinating 
Committee (MDCC) is a federal advisory committee established in 
accordance with the Muscular Dystrophy Community Assistance, Research, 
and Education Amendments of 2001 (MD-CARE Act; Pub. L. 107-84). The MD-
CARE Act was reauthorized in 2008 by Public Law 110-361, and again in 
2014 by Public Law 113-166. The MD-CARE Act specifies that the 
committee membership be composed of \2/3\ governmental agency 
representatives and \1/3\ public members. We are seeking nominations 
for two non-federal, public members at this time, due to turnover of 
committee membership. Nominations will be accepted between July 31 and 
August 31, 2018.
    Who is Eligible: Nominations are encouraged for new or 
reappointment of non-federal public members who can provide the public 
and/or patient perspectives to discussions of issues considered by the 
Committee. Self-nominations and nominations of other individuals are 
both permitted. Only one nomination per individual is required. 
Multiple nominations for the same individual will not increase 
likelihood of selection. Non-federal, public members may be selected 
from the pool of submitted nominations or other sources as needed to 
meet statutory requirements and to form a balanced committee that 
represents the diversity within the muscular dystrophy communities. 
Nominations are especially encouraged from leaders or representatives 
of muscular dystrophy research, advocacy, or service organizations, 
individuals with muscular dystrophy or their parents or guardians. In 
accordance with White House Office of Management and Budget guidelines 
(FR Doc. 2014- 19140), federally-registered lobbyists are not eligible.
    Committee Composition: The Department strives to ensure that the 
membership of HHS Federal advisory committees is fairly balanced in 
terms of points of view represented and the committee's function. Every 
effort is made to ensure that the views of all genders, all ethnic and 
racial groups, and people with disabilities are

[[Page 35667]]

represented on HHS Federal advisory committees and, therefore, the 
Department encourages nominations of qualified candidates from these 
groups. The Department also encourages geographic diversity in the 
composition of the Committee. Appointment to this Committee shall be 
made without discrimination on the basis of age, race, ethnicity, 
gender, sexual orientation, disability, and cultural, religious, or 
socioeconomic status. Requests for reasonable accommodation to enable 
participation on the Committee should be indicated in the nomination 
submission.
    Member Terms: Non-Federal public members of the Committee serve for 
a term of 3 years, and may serve for an unlimited number of terms if 
reappointed. Members may serve after the expiration of their terms, 
until their successors have taken office.
    Meetings and Travel: As specified by Public Law 113-166, the MDCC 
``shall meet no fewer than two times per calendar year.'' Travel 
expenses are provided for non-federal public Committee members to 
facilitate attendance at in-person meetings. Members are expected to 
make every effort to attend all full committee meetings, twice per 
year, either in person or via remote access. Participation in relevant 
subcommittee, working and planning group meetings, and workshops, is 
also encouraged.
    Submission Instructions and Deadline: Nominations are due by 5 p.m. 
EDT on August 31, 2018, and should be sent to Glen Nuckolls, Ph.D., by 
email to nuckollg@ninds.nih.gov.
    Nominations must include contact information for the nominee, a 
current curriculum vitae or resume of the nominee and a paragraph 
describing the qualifications of the person to represent some 
portion(s) of the muscular dystrophy research, advocacy and/or patient 
care communities.
    More information about the MDCC is available at https://mdcc.nih.gov/.

     Dated: July 24, 2018.
Walter J. Koroshetz,
Director, National Institute of Neurological Disorders and Stroke, 
National Institutes of Health.
[FR Doc. 2018-16112 Filed 7-26-18; 8:45 am]
 BILLING CODE 4140-01-P

35666 Federal Register / Vol. 83, No. 145 / Friday, July 27, 2018 / Notices proposed collection of information, Need and Use of Information toward research independence, as well including the validity of the Collection: The new Intramural as fosters and sustains diversity in the methodology and assumptions used; (3) Continuing Umbrella of Research biomedical research pipeline. Like the Ways to enhance the quality, utility, and Experiences (iCURE) program supports CURE program, iCURE strongly clarity of the information to be mentored research experiences for encourages the participation of collected; and (4) Ways to minimize the qualified post-baccalaureate (including individuals from underrepresented burden of the collection of information post masters) individuals, graduate populations and is aligned with NCI’s on those who are to respond, including students, and postdoctoral fellows in interest in diversity. The benefit of the use of appropriate automated, the multidisciplinary National Cancer collecting this information is to enable electronic, mechanical, or other Institute (NCI) intramural research the selection of the best matching technological collection techniques or environment. This information candidates for the iCURE program. The other forms of information technology. collection request are applications and a iCURE program aims to, 1. Enhance the reference letter to help evaluate the Proposed Collection Title: Intramural diversity of the NCI Intramural Research merits of the candidates and their Continuing Umbrella of Research Program (IRP), and 2. Promote the career potential match for the iCURE program. Experiences (iCURE) Application, 0925– progress of the iCURE scholars in cancer iCURE is an extension of the highly XXXX, Exp., Date XX/XXXX, EXISTING successful NCI Center to Reduce Cancer research. COLLECTION IN USE WITHOUT OMB Health Disparities’ (CRCHD) Continuing OMB approval is requested for 3 APPROVAL, National Cancer Institute Umbrella of Research Experiences years. There are no costs to respondents (NCI), National Institutes of Health (CURE) program which helps support other than their time. The total (NIH). the career progress of its scholars estimated burden hours are 305. ESTIMATED ANNUALIZED BURDEN HOURS Average Number of Number of time per Total annual Form name Type of respondent responses per respondents response burden hour respondent (in hours) Postbac Supplemental Application ... Post-Baccalaureate (Including Post- 50 1 30/60 25 Master’s) Individuals. Graduate Student Application ........... Graduate Students ........................... 30 1 2 60 Postdoctoral Fellowship Application Postdoctoral Candidates .................. 50 1 2 100 Reference Letter ............................... PIs, professors, supervisors ............. 240 1 30/60 120 Total ........................................... ........................................................... 370 370 ........................ 305 Patricia M. Busche, ADDRESSES: Nominations must be sent nominations and nominations of other Project Clearance Liaison, National Cancer to Glen Nuckolls, Ph.D., by email to individuals are both permitted. Only Institute, National Institutes of Health. nuckollg@ninds.nih.gov. one nomination per individual is [FR Doc. 2018–16053 Filed 7–26–18; 8:45 am] FOR FURTHER INFORMATION CONTACT: Glen required. Multiple nominations for the BILLING CODE 4140–01–P Nuckolls, Ph.D., by email to nuckollg@ same individual will not increase ninds.nih.gov. or (301) 496–5745. likelihood of selection. Non-federal, SUPPLEMENTARY INFORMATION: The public members may be selected from DEPARTMENT OF HEALTH AND Muscular Dystrophy Coordinating the pool of submitted nominations or HUMAN SERVICES Committee (MDCC) is a federal advisory other sources as needed to meet committee established in accordance statutory requirements and to form a National Institutes of Health with the Muscular Dystrophy balanced committee that represents the Community Assistance, Research, and diversity within the muscular dystrophy National Institute of Neurological Education Amendments of 2001 (MD– communities. Nominations are Disorders and Stroke, Muscular CARE Act; Pub. L. 107–84). The MD– especially encouraged from leaders or Dystrophy Coordinating Committee CARE Act was reauthorized in 2008 by representatives of muscular dystrophy Call for Committee Membership Public Law 110–361, and again in 2014 research, advocacy, or service Nominations by Public Law 113–166. The MD–CARE organizations, individuals with Act specifies that the committee muscular dystrophy or their parents or AGENCY: National Institutes of Health, guardians. In accordance with White membership be composed of 2⁄3 HHS. House Office of Management and governmental agency representatives ACTION: Notice. and 1⁄3 public members. We are seeking Budget guidelines (FR Doc. 2014– nominations for two non-federal, public 19140), federally-registered lobbyists are SUMMARY: The Office of the Secretary of members at this time, due to turnover of not eligible. the Department of Health and Human committee membership. Nominations Committee Composition: The Services (HHS) is seeking nominations will be accepted between July 31 and Department strives to ensure that the amozie on DSK3GDR082PROD with NOTICES1 for an individual to serve as a August 31, 2018. membership of HHS Federal advisory nonfederal public member on the Who is Eligible: Nominations are committees is fairly balanced in terms of Muscular Dystrophy Coordinating encouraged for new or reappointment of points of view represented and the Committee. non-federal public members who can committee’s function. Every effort is provide the public and/or patient made to ensure that the views of all DATES:Nominations are due by 5 p.m. perspectives to discussions of issues genders, all ethnic and racial groups, EDT on August 31, 2018. considered by the Committee. Self- and people with disabilities are VerDate Sep<11>2014 17:38 Jul 26, 2018 Jkt 244001 PO 00000 Frm 00063 Fmt 4703 Sfmt 4703 E:\FR\FM\27JYN1.SGM 27JYN1

Federal Register / Vol. 83, No. 145 / Friday, July 27, 2018 / Notices 35667 represented on HHS Federal advisory DEPARTMENT OF HEALTH AND chemically conjugated residue derived committees and, therefore, the HUMAN SERVICES from (((R-)-1-carboxy-2- Department encourages nominations of mercaptoethyl)carbamoyl)-L-glutamic qualified candidates from these groups. National Institutes of Health acid that is further bound to an Evans The Department also encourages blue analog (EB). The EB analog Prospective Grant of Exclusive Patent reversibly binds to circulating serum geographic diversity in the composition License: Radiotherapy for Metastatic albumin to provide a of the Committee. Appointment to this Castration-Resistant Prostate Cancer Committee shall be made without radiopharmaceutical that retains affinity discrimination on the basis of age, race, AGENCY: National Institutes of Health, and specificity to prostate specific ethnicity, gender, sexual orientation, HHS. membrane antigen (PSMA; in this case disability, and cultural, religious, or ACTION: Notice. PSMA-617). PSMA is a surface molecule shown to be specifically expressed by socioeconomic status. Requests for SUMMARY: The National Heart, Lung and prostate tumor cells. PSMA expression reasonable accommodation to enable Blood Institute (NHLBI), National levels correlate with disease stage and participation on the Committee should Institutes of Health, Department of with hormone refractory cancers. be indicated in the nomination Although most PSMA expression Health and Human Services, is submission. appears to be restricted to the prostate contemplating the grant of an exclusive Member Terms: Non-Federal public commercialization patent license to cancer, low levels of expression can also members of the Committee serve for a Sinotau Pharmaceutical Group, be detected in the brain, kidneys, term of 3 years, and may serve for an headquartered in Beijing, China, to salivary glands, and small intestine. The unlimited number of terms if practice the inventions embodied in the antigen is also shown to be expressed by reappointed. Members may serve after patent application(s) listed in the neovascular tumor vessels of multiple the expiration of their terms, until their Supplementary Information section of other cancers. Inclusion of the Evans successors have taken office. this notice. blue analog promotes high DATES: Only written comments and/or internalization and retention rates of the Meetings and Travel: As specified by conjugated target ligand, and therefore, applications for a license which are Public Law 113–166, the MDCC ‘‘shall higher accumulation in PSMA positive received by the NHLBI Office of meet no fewer than two times per tumors. Labeling EB-PSMA-617 Technology Transfer and Development calendar year.’’ Travel expenses are August 27, 2018 will be considered. derivatives with the therapeutic beta provided for non-federal public emitters, e.g., 90Y, 86Y, and 177Lu gives ADDRESSES: Requests for copies of the Committee members to facilitate rise to improved tumor response and patent applications, inquiries, and attendance at in-person meetings. survival rates. comments relating to the contemplated Members are expected to make every exclusive patent license should be This notice is made in accordance effort to attend all full committee directed to: Michael Shmilovich, Esq., with 35 U.S.C. 209 and 37 CFR part 404. meetings, twice per year, either in Senior Licensing and Patent Manager, The prospective exclusive patent license person or via remote access. 31 Center Drive, Room 4A29, MSC2479, will be royalty bearing and may be Participation in relevant subcommittee, Bethesda, MD 20892–2479, phone granted unless within fifteen (15) days working and planning group meetings, number 301–435–5019, or shmilovm@ from the date of this published notice, and workshops, is also encouraged. mail.nih.gov. the NHLBI receives written evidence Submission Instructions and SUPPLEMENTARY INFORMATION: The and argument that establishes that the Deadline: Nominations are due by 5 following and all continuing U.S. and grant of the license would not be p.m. EDT on August 31, 2018, and foreign patents/patent applications consistent with the requirements of 35 should be sent to Glen Nuckolls, Ph.D., thereof are the intellectual properties to U.S.C. 209 and 37 CFR part 404. by email to nuckollg@ninds.nih.gov. be licensed under the prospective Complete applications for a license in agreement to Sinotau Pharmaceutical the prospective field of use that are Nominations must include contact Group: U.S. Provisional Patent timely filed in response to this notice information for the nominee, a current Application 62/633,648, ‘‘Chemical will be treated as objections to the grant curriculum vitae or resume of the Conjugates Of Evans Blue Derivatives of the contemplated exclusive patent nominee and a paragraph describing the And Their Use As Radiotherapy And qualifications of the person to represent license. Imaging Agents For Targeting Prostate some portion(s) of the muscular Comments and objections submitted Cancer,’’ filed February 22, 2018 (HHS dystrophy research, advocacy and/or to this notice will not be made available Ref. No. E–054–2018–0). The patent patient care communities. for public inspection and, to the extent rights in this invention have been permitted by law, will not be released More information about the MDCC is assigned to the Government of the under the Freedom of Information Act, available at https://mdcc.nih.gov/. United States of America. The 5 U.S.C. 552. perspective license would be granted Dated: July 24, 2018. Dated: July 19, 2018. worldwide and in a field of use not Walter J. Koroshetz, broader than radiotherapeutics for Michael A. Shmilovich, Director, National Institute of Neurological metastatic castration-resistant prostate Senior Licensing and Patenting Manager, amozie on DSK3GDR082PROD with NOTICES1 Disorders and Stroke, National Institutes of cancer. National Heart, Lung, and Blood Institute, Health. The invention covered by the patents Office of Technology Transfer and [FR Doc. 2018–16112 Filed 7–26–18; 8:45 am] and patent applications pertaining to Development. BILLING CODE 4140–01–P HHS Ref. No. E–054–2018–0 pertain to [FR Doc. 2018–16066 Filed 7–26–18; 8:45 am] a therapeutic agent that includes a BILLING CODE 4140–01–P VerDate Sep<11>2014 17:38 Jul 26, 2018 Jkt 244001 PO 00000 Frm 00064 Fmt 4703 Sfmt 4703 E:\FR\FM\27JYN1.SGM 27JYN1


Document Created: 2018-07-27 04:04:31
Document Modified: 2018-07-27 04:04:31
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesNominations are due by 5 p.m. EDT on August 31, 2018.
ContactGlen Nuckolls, Ph.D., by email to [email protected] or (301) 496-5745.
FR Citation83 FR 35666 
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