83 FR 50668 - Submission for OMB Review; 30-Day Comment Request; Generic Clearance To Conduct Voluntary Customer/Partner Surveys (NLM)
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health Federal Register Volume 83, Issue 195 (October 9, 2018)
National Institutes of Health
Federal Register Volume 83, Issue 195 (October 9, 2018)
| Page Range | 50668-50669 | |
| FR Document | 2018-21818 |
[Federal Register Volume 83, Number 195 (Tuesday, October 9, 2018)] [Notices] [Pages 50668-50669] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-21818] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Submission for OMB Review; 30-Day Comment Request; Generic Clearance To Conduct Voluntary Customer/Partner Surveys (NLM) AGENCY: National Institutes of Health, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: In compliance with the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. DATES: Comments regarding this information collection are best assured of having their full effect if received within 30-days of the date of this publication. ADDRESSES: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, [email protected] or by fax to 202-395-6974, Attention: Desk Officer for NIH. FOR FURTHER INFORMATION CONTACT: To request more information on the proposed project or to obtain a copy of [[Page 50669]] the data collection plans and instruments, contact: contact: David Sharlip, National Library of Medicine, Building 38A, Room B2N12, 8600 Rockville Pike, Bethesda, MD 20894, or call non-toll-free number 301- 827-6361 or email your request to [email protected]. SUPPLEMENTARY INFORMATION: This proposed information collection was previously published in the Federal Register on July 20, 2018, pages 34599-34600 (83 FR 34599-34600) and allowed 60 days for public comment. NLM received one comment in response to the 60-Day Federal Register Notice. The purpose of this notice is to allow an additional 30 days for public comment. The National Library of Medicine (NLM), National Institutes of Health, may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. Proposed Collection: Generic Clearance to Conduct Voluntary Customer/Partner Surveys (NLM), 0925-0476, Expiration Date 09/30/2018, REINSTATEMENT WITHOUT CHANGE, National Library of Medicine (NLM), National Institutes of Health (NIH). Need and Use of Information Collection: In 1994, the NLM was designated a ``Federal Reinvention Laboratory'' with a major objective of improving its methods of delivering information to the public. At a minimum, necessary elements in improving the delivery of information include: (1) Development of easy-to-use access and delivery mechanisms that promote the public's understanding of health information, drawing on research in lay terminology, graphical and multimedia presentations; (2) assisting those providing health information to the public to make effective use of electronic services through internet connections, training, and other means, with an emphasis on those serving minority groups, low income populations, and seniors; (3) promoting integrations of NLM services with other electronic services covering regional, state, or local health information; and (4) conducting and supporting research, development, and evaluation of the public's health information needs, information seeking behavior and learning styles, information systems that meet the public's needs, and the impact of access to information. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 750. Estimated Annualized Burden Hours -------------------------------------------------------------------------------------------------------------------------------------------------------- Table A.12-1 Estimates of Annual Burden Hours --------------------------------------------------------------------------------------------------------------------------------------------------------- Annual Average time Type of collection Type of respondents Number of frequency per per response Total burden respondents response (minutes/hour) hours -------------------------------------------------------------------------------------------------------------------------------------------------------- Customer Satisfaction Surveys.............. General Public............................. 1,000 1 20/60 333 Focus Groups............................... Health Professionals....................... 500 1 15/60 125 Usability and Pilot Testing................ Librarians................................. 500 1 20/60 167 Interviews or Small Discussion Groups...... Health Educators........................... 500 1 15/60 125 --------------------------------------------------------------- Total.................................. ........................................... 2,500 2,500 .............. 750 -------------------------------------------------------------------------------------------------------------------------------------------------------- Dated: September 21, 2018. David H. Sharlip, Project Clearance Liaison, National Library of Medicine, National Institutes of Health. [FR Doc. 2018-21818 Filed 10-5-18; 8:45 am] BILLING CODE 4140-01-P
![50668 Federal Register / Vol. 83, No. 195 / Tuesday, October 9, 2018 / Notices
neutralizing antibody.’’ Science Recombinant RSV B1 Expressing eGFP • In vitro data assessment
352.6287 (2016): 828–833. as a Reporter Gene Inventors: Ursula Buchholz (NIAID),
(b) Xu, Kai, et al. ‘‘Epitope-based Description of Technology: The Peter Collins (NIAID).
vaccine design yields fusion inventors have created a reverse Publications: None.
peptide-directed antibodies that genetics system for RSV strain B1 of Intellectual Property: HHS Reference
neutralize diverse strains of HIV– antigenic subgroup B encoding a No. E–159–2018–0.
1.’’ Nature Medicine 24, 857–867 replication-competent recombinant RSV Licensing Contact: Peter Soukas, J.D.,
(2018). that contains a codon-optimized G ORF 301–594–8730; peter.soukas@nih.gov.
and expresses enhanced green Collaborative Research Opportunity:
Intellectual Property: HHS Reference fluorescence protein (GFP). There are The National Institute of Allergy and
Number E–279–2016 includes U.S. two antigenic subgroups of RSV, Infectious Diseases is seeking statements
Provisional Patent Application Number subgroups A and B, and most of the of capability or interest from parties
62/403,266 filed 10/03/2016 and PCT available information and reagents are interested in collaborative research to
Application Number PCT/US2017/ for subgroup A. Immunity against either further develop, evaluate or
054959 filed 10/03/2017 (pending). subgroup has reduced effectiveness in commercialize for development of a
Licensing Contact: Barry Buchbinder, restricting the heterologous subgroup, vaccine for respiratory or other
Ph.D., 240–627–3678; suggesting that an effective RSV vaccine infections. For collaboration
barry.buchbinder@nih.gov might need to contain both subgroups. opportunities, please contact Peter
Dated: September 25, 2018. The sequence of the wild type G gene Soukas, J.D., 301–594–8730;
was refractory to cloning into full-length peter.soukas@nih.gov.
Suzanne M. Frisbie,
Deputy Director, Technology Transfer and antigenomic cDNA in E. coli, and so the Dated: September 25, 2018.
Intellectual Property Office, National Institute inventors made and successfully used a Suzanne M. Frisbie,
of Allergy and Infectious Diseases. codon optimized version. In addition, Deputy Director, Technology Transfer and
[FR Doc. 2018–21762 Filed 10–5–18; 8:45 am] the inventors inserted an eGFP gene into Intellectual Property Office, National Institute
BILLING CODE 4140–01–P
the first gene position (promoter of Allergy and Infectious Diseases.
proximal). The resulting virus is [FR Doc. 2018–21767 Filed 10–5–18; 8:45 am]
replication-competent and efficiently BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND expresses GFP in infected cells. This
HUMAN SERVICES virus can be used as a tool to detect
RSV-neutralizing antibodies to RSV DEPARTMENT OF HEALTH AND
National Institutes of Health subgroup B in a plaque-reduction assay. HUMAN SERVICES
It also can be used to evaluate RSV
Government-Owned Inventions; infection in vitro and in vivo using GFP National Institutes of Health
Availability for Licensing fluorescence to track infection. The
antigenomic cDNA clone also provides Submission for OMB Review; 30-Day
AGENCY: National Institutes of Health, the starting material for making live- Comment Request; Generic Clearance
HHS. attenuated subgroup B-specific RSV To Conduct Voluntary Customer/
ACTION: Notice. vaccine candidates containing defined Partner Surveys (NLM)
mutations. These defined mutations can AGENCY: National Institutes of Health,
SUMMARY: The invention listed below is include ones that we previously HHS.
owned by an agency of the U.S. developed for RSV subgroup A, and
ACTION: Notice.
Government and is available for include stabilized point mutations,
licensing to achieve expeditious stabilized codon-deletions, and gene- SUMMARY: In compliance with the
commercialization of results of deletions. Paperwork Reduction Act of 1995, the
federally-funded research and The present invention provides a National Institutes of Health (NIH) has
development. Foreign patent reverse genetics system encoding strain submitted to the Office of Management
applications are filed on selected B1 of RSV subgroup B containing a and Budget (OMB) a request for review
inventions to extend market coverage codon-optimized G ORF and encoding and approval of the information
for companies and may also be available eGFP. This provides a tool for RSV collection listed below.
for licensing. subgroup B serology assays, for tracking DATES: Comments regarding this
RSV infection, and a starting point for information collection are best assured
FOR FURTHER INFORMATION CONTACT:
making attenuated subgroup B strains of having their full effect if received
Peter Soukas, J.D., 301–594–8730; for vaccine purposes.
peter.soukas@nih.gov. Licensing within 30-days of the date of this
This technology is available for
information and copies of the patent publication.
licensing for commercial development
applications listed below may be in accordance with 35 U.S.C. 209 and 37 ADDRESSES: Written comments and/or
obtained by communicating with the CFR part 404, as well as for further suggestions regarding the item(s)
indicated licensing contact at the development and evaluation under a contained in this notice, especially
Technology Transfer and Intellectual research collaboration. regarding the estimated public burden
Property Office, National Institute of Potential Commercial Applications: and associated response time, should be
Allergy and Infectious Diseases, 5601 • Viral diagnostics directed to the: Office of Management
amozie on DSK3GDR082PROD with NOTICES1
Fishers Lane, Rockville, MD, 20852; tel. • Vaccine research and Budget, Office of Regulatory Affairs,
301–496–2644. A signed Confidential • Serology assays OIRA_submission@omb.eop.gov or by
Disclosure Agreement will be required • Vaccine manufacture fax to 202–395–6974, Attention: Desk
to receive copies of unpublished patent Competitive Advantages: Officer for NIH.
applications. • Ease of manufacture FOR FURTHER INFORMATION CONTACT: To
SUPPLEMENTARY INFORMATION: • Unique research tool request more information on the
Technology description follows. Development Stage: proposed project or to obtain a copy of
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![Federal Register / Vol. 83, No. 195 / Tuesday, October 9, 2018 / Notices 50669
the data collection plans and In compliance with Section health information, drawing on research
instruments, contact: contact: David 3507(a)(1)(D) of the Paperwork in lay terminology, graphical and
Sharlip, National Library of Medicine, Reduction Act of 1995, the National multimedia presentations; (2) assisting
Building 38A, Room B2N12, 8600 Institutes of Health (NIH) has submitted those providing health information to
Rockville Pike, Bethesda, MD 20894, or to the Office of Management and Budget the public to make effective use of
call non-toll-free number 301–827–6361 (OMB) a request for review and electronic services through internet
or email your request to sharlipd@ approval of the information collection connections, training, and other means,
mail.nih.gov. listed below. with an emphasis on those serving
SUPPLEMENTARY INFORMATION: This Proposed Collection: Generic minority groups, low income
proposed information collection was Clearance to Conduct Voluntary populations, and seniors; (3) promoting
previously published in the Federal Customer/Partner Surveys (NLM), 0925– integrations of NLM services with other
Register on July 20, 2018, pages 34599– 0476, Expiration Date 09/30/2018, electronic services covering regional,
34600 (83 FR 34599–34600) and REINSTATEMENT WITHOUT state, or local health information; and
allowed 60 days for public comment. CHANGE, National Library of Medicine
(4) conducting and supporting research,
NLM received one comment in response (NLM), National Institutes of Health
development, and evaluation of the
to the 60-Day Federal Register Notice. (NIH).
public’s health information needs,
The purpose of this notice is to allow an Need and Use of Information
information seeking behavior and
additional 30 days for public comment. Collection: In 1994, the NLM was
designated a ‘‘Federal Reinvention learning styles, information systems that
The National Library of Medicine
(NLM), National Institutes of Health, Laboratory’’ with a major objective of meet the public’s needs, and the impact
may not conduct or sponsor, and the improving its methods of delivering of access to information.
respondent is not required to respond information to the public. At a OMB approval is requested for 3
to, an information collection that has minimum, necessary elements in years. There are no costs to respondents
been extended, revised, or implemented improving the delivery of information other than their time. The total
on or after October 1, 1995, unless it include: (1) Development of easy-to-use estimated annualized burden hours are
displays a currently valid OMB control access and delivery mechanisms that 750.
number. promote the public’s understanding of
ESTIMATED ANNUALIZED BURDEN HOURS
Table A.12–1 Estimates of Annual Burden Hours
Annual Average time
Type of Number of Total burden
Type of collection frequency per per response
respondents respondents hours
response (minutes/hour)
Customer Satisfaction Surveys .............................. General Public ............ 1,000 1 20/60 333
Focus Groups ......................................................... Health Professionals ... 500 1 15/60 125
Usability and Pilot Testing ..................................... Librarians .................... 500 1 20/60 167
Interviews or Small Discussion Groups ................. Health Educators ........ 500 1 15/60 125
Total ................................................................ ..................................... 2,500 2,500 ........................ 750
Dated: September 21, 2018. dated October 8, 2017, and related Brown Fund; 97.032, Crisis Counseling;
David H. Sharlip, determinations. 97.033, Disaster Legal Services; 97.034,
Project Clearance Liaison, National Library Disaster Unemployment Assistance (DUA);
DATES: The change occurred on August
of Medicine, National Institutes of Health. 97.046, Fire Management Assistance Grant;
29, 2018. 97.048, Disaster Housing Assistance to
[FR Doc. 2018–21818 Filed 10–5–18; 8:45 am]
FOR FURTHER INFORMATION CONTACT: Individuals and Households In Presidentially
BILLING CODE 4140–01–P
Dean Webster, Office of Response and Declared Disaster Areas; 97.049,
Recovery, Federal Emergency Presidentially Declared Disaster Assistance—
Management Agency, 500 C Street SW, Disaster Housing Operations for Individuals
DEPARTMENT OF HOMELAND Washington, DC 20472, (202) 646–2833. and Households; 97.050, Presidentially
SECURITY
SUPPLEMENTARY INFORMATION: The Declared Disaster Assistance to Individuals
Federal Emergency Management Federal Emergency Management Agency and Households—Other Needs; 97.036,
(FEMA) hereby gives notice that Disaster Grants—Public Assistance
Agency
pursuant to the authority vested in the (Presidentially Declared Disasters); 97.039,
[Internal Agency Docket No. FEMA–3395– Administrator, under Executive Order Hazard Mitigation Grant.
EM; Docket ID FEMA–2018–0001] 12148, as amended, Thomas J. McCool,
Brock Long,
of FEMA is appointed to act as the
Florida; Amendment No. 3 to Notice of Administrator, Federal Emergency
Federal Coordinating Officer for this
an Emergency Declaration Management Agency.
emergency.
amozie on DSK3GDR082PROD with NOTICES1
This action terminates the [FR Doc. 2018–21792 Filed 10–5–18; 8:45 am]
AGENCY: Federal Emergency
Management Agency, DHS. appointment of Allan Jarvis as Federal BILLING CODE 9111–11–P
ACTION: Notice. Coordinating Officer for this emergency.
The following Catalog of Federal Domestic
SUMMARY: This notice amends the notice Assistance Numbers (CFDA) are to be used
of an emergency declaration for the for reporting and drawing funds: 97.030,
State of Florida (FEMA–3395–EM), Community Disaster Loans; 97.031, Cora
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Document Created: 2018-10-06 00:59:08
Document Modified: 2018-10-06 00:59:08
| 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. | |
| Dates | Comments regarding this information collection are best assured of having their full effect if received within 30-days of the date of this publication. | |
| Contact | To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact: contact: David Sharlip, National Library of Medicine, Building 38A, Room B2N12, 8600 Rockville Pike, Bethesda, MD 20894, or call non-toll-free number 301- 827-6361 or email your request to [email protected] | |
| FR Citation | 83 FR 50668 |
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