81 FR 30541 - Submission for OMB Review; 30-Day Comment Request; National Institutes of Health (NIH) Loan Repayment Programs; Office of the Director (OD)
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health Federal Register Volume 81, Issue 95 (May 17, 2016)
National Institutes of Health
Federal Register Volume 81, Issue 95 (May 17, 2016)
| Page Range | 30541-30543 | |
| FR Document | 2016-11618 |
[Federal Register Volume 81, Number 95 (Tuesday, May 17, 2016)] [Notices] [Pages 30541-30543] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-11618] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Submission for OMB Review; 30-Day Comment Request; National Institutes of Health (NIH) Loan Repayment Programs; Office of the Director (OD) Summary: Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Division of Loan Repayment (DLR), the National Institutes of Health (NIH), has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. This proposed information collection was previously published in the Federal Register on February 19, 2016, and page numbers 8514-8516, and allowed 60 days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The NIH 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. Direct Comments to OMB: 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 [[Page 30542]] of Management and Budget, Office of Regulatory Affairs, [email protected] or by fax to 202-395-6974, Attention: NIH Desk Officer. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30 days of the date of this publication. For Further Information: To obtain a copy of the data collection plans and instruments or request more information on the proposed project contact: Steve Boehlert, Director of Operations, Division of Loan Repayment, National Institutes of Health, 6011 Executive Blvd., Room 206 (MSC 7650), Bethesda, Maryland 20892-7650. Mr. Boehlert may be contacted via email at [email protected] or by calling 301-451-4465. Formal requests for additional plans and instruments must be requested in writing. Proposed Collection: National Institutes of Health (NIH) Loan Repayment Programs (LRP). Type of Information Collection Request: Extension of a currently approved collection (OMB No. 0925-0361, expiration date 06/30/17). Form Numbers: NIH 2674-1, NIH 2674-2, NIH 2674-3, NIH 2674-4, NIH 2674-5, NIH 2674-6, NIH 2674-7, NIH 2674-8, NIH 2674-9, NIH 2674-10, NIH 2674-11, NIH 2674-12, NIH 2674-13, NIH 2674- 14, NIH 2674-15, NIH 2674-16, NIH 2674-17, NIH 2674-18, NIH 2674-19, and NIH 2674-20. Need and Use of Information Collection: The NIH makes available financial assistance, in the form of educational loan repayment, to M.D., Ph.D., Pharm.D., Psy.D., D.O., D.D.S., D.M.D., D.P.M., DC, N.D., O.D., D.V.M., or equivalent degree holders who perform biomedical or behavioral research in NIH intramural laboratories or as extramural grantees or scientists funded by domestic non-profit organizations for a minimum of two years (three years for the General Research Loan Repayment Program (LRP)) in research areas supporting the mission and priorities of the NIH. The AIDS Research Loan Repayment Program (AIDS-LRP) is authorized by Section 487A of the Public Health Service Act (42 U.S.C. 288-1); the Clinical Research Loan Repayment Program for Individuals from Disadvantaged Backgrounds (CR-LRP) is authorized by Section 487E (42 U.S.C. 288-5); the General Research Loan Repayment Program (GR-LRP) is authorized by Section 487C of the Public Health Service Act (42 U.S.C. 288-3); the Clinical Research Loan Repayment Program (LRP-CR) is authorized by Section 487F (42 U.S.C. 288-5a); the Pediatric Research Loan Repayment Program (PR-LRP) is authorized by Section 487F (42 U.S.C. 288-6); the Extramural Clinical Research LRP for Individuals from Disadvantaged Backgrounds (ECR-LRP) is authorized by an amendment to Section 487E (42 U.S.C. 288-5); the Contraception and Infertility Research LRP (CIR-LRP) is authorized by Section 487B (42 U.S.C. 288-2); and the Health Disparities Research Loan Repayment Program (HD-LRP) is authorized by Section 485G (42 U.S.C. 287c-33). The Loan Repayment Programs can repay up to $35,000 per year toward a participant's extant eligible educational loans, directly to financial institutions. The information proposed for collection will be used by the Division of Loan Repayment to determine an applicant's eligibility for participation in the program. Frequency of Response: Initial application and one or two-year renewal application. Affected Public: Individuals or households; Nonprofits; and Businesses or other for-profit. Type of Respondents: Physicians, other scientific or medical personnel, and institutional representatives. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 33,242. Estimated Annualized Burden Hours ---------------------------------------------------------------------------------------------------------------- Estimated Number of number of Average burden Annual burden Type of respondent respondents responses per hours per hours respondent response requested ---------------------------------------------------------------------------------------------------------------- Intramural LRPs: Initial Applicants.......................... 40 1 10 400 Advisors/Supervisors........................ 40 1 1 40 Recommenders................................ 120 1 30/60 60 Financial Institutions...................... 8 1 15/60 2 --------------------------------------------------------------- Subtotal................................ 208 .............. .............. 502 --------------------------------------------------------------- Extramural LRPs: Initial Applicants.......................... 1,650 1 11 18,150 Advisors/Supervisors........................ 1,480 1 1 1,480 Recommenders................................ 4,950 1 30/60 2,475 Financial Institutions...................... 100 1 15/60 25 --------------------------------------------------------------- Subtotal................................ 8,180 .............. .............. 22,130 --------------------------------------------------------------- Intramural LRPs: Renewal Applicants.......................... 40 1 7 280 Advisors/Supervisors........................ 40 1 2 80 --------------------------------------------------------------- Subtotal................................ 80 .............. .............. 360 --------------------------------------------------------------- Extramural LRPS: Renewal Applicants.......................... 1,000 1 8 8,000 Advisors/Supervisors........................ 750 1 1 750 Recommenders................................ 3,000 1 30/60 1,500 --------------------------------------------------------------- Subtotal............................ 4,750 .............. .............. 10,250 --------------------------------------------------------------- [[Page 30543]] Total................................... 13,218 .............. .............. 33,242 ---------------------------------------------------------------------------------------------------------------- Dated: May 11, 2016. Lawrence A. Tabak, Deputy Director, National Institutes of Health. [FR Doc. 2016-11618 Filed 5-16-16; 8:45 am] BILLING CODE 4140-01-P
![Federal Register / Vol. 81, No. 95 / Tuesday, May 17, 2016 / Notices 30541
regulated clinical investigations. In including capital costs or operating and Bethesda, MD 20892–9823, (240) 669–5082,
particular, the draft guidance provides maintenance costs, because sponsors Travis.Taylor@nih.gov.
recommendations on the following: (1) and others already have and are Name of Committee: National Institute of
Deciding whether and how to use EHRs experienced with using computer-based Allergy and Infectious Diseases, Special
as a source of data in clinical equipment and software necessary to be Emphasis Panel, Rapid Assessment of Zika
Virus (ZIKV) Complications (R21).
investigations; (2) using EHRs that are consistent with the draft guidance. Date: June 14, 2016.
interoperable with electronic systems Time: 12:00 p.m. to 7:00 p.m.
supporting clinical investigations; (3) III. Electronic Access
Agenda: To review and evaluate grant
ensuring the quality and the integrity of Persons with access to the Internet applications.
EHR data that are collected and used as may obtain the draft guidance at http:// Place: National Institutes of Health 3F100,
electronic source data in clinical www.fda.gov/Drugs/ 5601 Fishers Lane, Rockville, MD 20892
investigations; and (4) ensuring that the (Telephone Conference Call).
GuidanceCompliance
use of EHR data collected and used as Contact Person: Amir E. Zeituni, Ph.D.,
RegulatoryInformation/Guidances/ Scientific Review Officer, Scientific Review
electronic source data in clinical default.htm, http://www.fda.gov/ Program, Division of Extramural Activities
investigations meet FDA’s inspection, BiologicsBloodVaccines/ NIAID/NIH/DHHS, 5601 Fishers Lane, MSC–
recordkeeping, and record retention GuidanceCompliance 9834 Rockville, MD 20852, 301–496–2550,
requirements. In an effort to modernize RegulatoryInformation/Guidances/ amir.zeituni@nih.gov.
and streamline clinical investigations, default.htm, http://www.fda.gov/ (Catalogue of Federal Domestic Assistance
the goals of the draft guidance are to MedicalDevices/DeviceRegulation Program Nos. 93.855, Allergy, Immunology,
facilitate use of EHR data in clinical andGuidance/GuidanceDocuments/ and Transplantation Research; 93.856,
investigations and to promote the Microbiology and Infectious Diseases
default.htm, or http://
interoperability of EHRs and electronic Research, National Institutes of Health, HHS)
www.regulations.gov.
systems supporting the clinical Dated: May 11, 2016.
investigation. Dated: May 11, 2016.
This draft guidance is being issued Leslie Kux, Natasha M. Copeland,
consistent with FDA’s good guidance Associate Commissioner for Policy. Program Analyst, Office of Federal Advisory
Committee Policy.
practices regulation (21 CFR 10.115). [FR Doc. 2016–11564 Filed 5–16–16; 8:45 am]
The draft guidance, when finalized, will [FR Doc. 2016–11554 Filed 5–16–16; 8:45 am]
BILLING CODE 4164–01–P
represent the current thinking of FDA BILLING CODE 4140–01–P
on the use of EHR data in clinical
investigations. It does not establish any DEPARTMENT OF HEALTH AND
rights for any person and is not binding HUMAN SERVICES DEPARTMENT OF HEALTH AND
on FDA or the public. You can use an HUMAN SERVICES
alternative approach if it satisfies the National Institutes of Health
National Institutes of Health
requirements of the applicable statutes
and regulations. National Institute of Allergy and
Infectious Diseases; Notice of Closed Submission for OMB Review; 30-Day
II. Paperwork Reduction Act of 1995 Meetings Comment Request; National Institutes
of Health (NIH) Loan Repayment
This draft guidance refers to Programs; Office of the Director (OD)
collections of information that are Pursuant to section 10(d) of the
subject to review by the Office of Federal Advisory Committee Act, as Summary: Under the provisions of
Management and Budget (OMB) under amended (5 U.S.C. App.), notice is Section 3507(a)(1)(D) of the Paperwork
the Paperwork Reduction Act of 1995 hereby given of the following meetings. Reduction Act of 1995, the Division of
(44 U.S.C. 3501–3520). The draft The meetings will be closed to the Loan Repayment (DLR), the National
guidance pertains to sponsors, clinical public in accordance with the Institutes of Health (NIH), has submitted
investigators, contract research provisions set forth in sections to the Office of Management and Budget
organizations, IRBs, and other interested 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., (OMB) a request to review and approve
parties who use EHR systems as as amended. The contract proposals and the information collection listed below.
electronic source data in FDA-regulated the discussions could disclose This proposed information collection
clinical investigations and who send confidential trade secrets or commercial was previously published in the Federal
certain information to FDA or others or property such as patentable material, Register on February 19, 2016, and page
who keep certain records and make and personal information concerning numbers 8514–8516, and allowed 60
them available to FDA inspectors. The individuals associated with the contract days for public comment. No public
collections of information discussed in proposals, the disclosure of which comments were received. The purpose
the draft guidance are contained in our would constitute a clearly unwarranted of this notice is to allow an additional
investigational new drug regulations in invasion of personal privacy. 30 days for public comment. The NIH
part 312 (21 CFR part 312), approved Name of Committee: National Institute of may not conduct or sponsor, and the
under OMB control number 0910–0014, Allergy and Infectious Diseases, Special respondent is not required to respond
including §§ 312.58(a) and 312.62(b); Emphasis Panel, NIAID Peer Review Meeting. to, an information collection that has
investigational device exemption Date: June 9, 2016. been extended, revised, or implemented
regulations in § 812.140 (21 CFR Time: 1:00 p.m. to 5:00 p.m. on or after October 1, 1995, unless it
812.140) approved under OMB control Agenda: To review and evaluate contract
jstallworth on DSK7TPTVN1PROD with NOTICES
displays a currently valid OMB control
number 0910–0078; and electronic proposals. number.
records; electronic signatures Place: National Institutes of Health, Room Direct Comments to OMB: Written
3G61, 5601 Fishers Lane, Rockville, MD
regulations in 21 CFR part 11, approved 20892 (Telephone Conference Call).
comments and/or suggestions regarding
under OMB control number 0910–0303. Contact Person: Travis J Taylor, Ph.D., the item(s) contained in this notice,
The use of EHR systems as a source of Scientific Review Officer, Scientific Review especially regarding the estimated
data, as described in the draft guidance, Program, Division of Extramural Activities, public burden and associated response
would not result in any new costs, Room 3G62B 5601 Fishers Lane, MSC 9823, time, should be directed to the: Office
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![Federal Register / Vol. 81, No. 95 / Tuesday, May 17, 2016 / Notices 30543
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Estimated Average Annual
Number of number of
Type of respondent burden hours burden hours
respondents responses per per response requested
respondent
Total ................................................................................................... 13,218 ........................ ........................ 33,242
Dated: May 11, 2016. diafiltering the biologic composition 2. US Food and Drug Administration.
Lawrence A. Tabak, into a composition comprising FDA approves first therapy for high-risk
Deputy Director, National Institutes of Health. phosphate buffered saline (PBS) to neuroblastoma.http://www.fda.gov/
[FR Doc. 2016–11618 Filed 5–16–16; 8:45 am] obtain a purified composition. The NewsEvents/Newsroom/
BILLING CODE 4140–01–P
method is particularly useful for PressAnnouncements/ucm437460.htm
removing one or more impurities from 3. WO2016015048 METHOD FOR
the biologic composition, such as bis(2- PURIFYING ANTIBODIES https://
DEPARTMENT OF HEALTH AND hydroxyethyl)amino- patentscope.wipo.int/search/en/
HUMAN SERVICES tris(hydroxymethyl)methane (Bis- detail.jsf?docId=WO2016015048
tris).The technology is directed to large Contact Information: Requests for
National Institutes of Health scale manufacturing of Chimeric 14.18 copies of the patent application or
(Ch14.18) monoclonal antibodies. inquiries about licensing, research
Government-Owned Inventions; Ch14.18 is an anti-GD2 monoclonal collaborations, and co-development
Availability for Licensing antibody and has been described in opportunities should be sent to John D.
AGENCY: National Institutes of Health, Gillies et al., Journal of Immunological Hewes, Ph.D., email: john.hewes@
HHS. Methods 125:191–202 (1989). nih.gov.
Potential Commercial Applications:
ACTION: Notice. • Large scale manufacturing of Dated: May 11, 2016.
chimeric monoclonal antibodies John D. Hewes,
SUMMARY: The invention listed below is
owned by an agency of the U.S. Value Proposition: Technology Transfer Specialist, Technology
• Cost effective means of removing Transfer Center, National Cancer Institute.
Government and is available for
impurities to produce GMP grade [FR Doc. 2016–11556 Filed 5–16–16; 8:45 am]
licensing and/or co-development in the
chimeric antibodies for regulatory BILLING CODE 4140–01–P
U.S. in accordance with 35 U.S.C. 209
approval.
and 37 CFR part 404 to achieve Development Stage: Clinical Phase II,
expeditious commercialization of FDA/EMA approved Chemistry, DEPARTMENT OF HEALTH AND
results of federally-funded research and Manufacturing and Controls (CMC) large HUMAN SERVICES
development. Foreign patent scale manufacturing to produce GMP
applications are filed on selected grade chimeric antibodies. National Institutes of Health
inventions to extend market coverage Inventor(s): David A. Meh (United
for companies and may also be available Therapeutics Corporation), Timothy Government-Owned Inventions;
for licensing and/or co-development. Atolagbe (United Therapeutics Availability for Licensing
ADDRESSES: Invention Development and Corporation), G. Mark Farquharson AGENCY: National Institutes of Health,
Marketing Unit, Technology Transfer (United Therapeutics Corporation), HHS.
Center, National Cancer Institute, 9609 Samir Shaban (National Cancer ACTION: Notice.
Medical Center Drive, Mail Stop 9702, Institute), Mary Koleck (National Cancer
Rockville, MD 20850–9702. Institute), George Mitra (National Cancer SUMMARY: The invention listed below is
FOR FURTHER INFORMATION CONTACT: Institute). owned by an agency of the U.S.
Information on licensing and co- Intellectual Property: Government and is available for
development research collaborations, HHS Ref. No. E–291–2014/0–US–01, licensing and/or co-development in the
and copies of the U.S. patent corresponding to US Provisional Patent U.S. in accordance with 35 U.S.C. 209
applications listed below may be App. No. 62/028,994, filed July 25, and 37 CFR part 404 to achieve
obtained by contacting: Attn. Invention 2014, entitled ‘‘Method for Purifying expeditious commercialization of
Development and Marketing Unit, Antibodies using PBS’’ results of federally-funded research and
Technology Transfer Center, National HHS Ref. No. E–291–2014/0–US–02, development. Foreign patent
Cancer Institute, 9609 Medical Center corresponding to US Patent App. No. applications are filed on selected
Drive, Mail Stop 9702, Rockville, MD 14/809,211, filed July 25, 2015, entitled inventions to extend market coverage
20850–9702, Tel. 240–276–5515 or ‘‘Method for Purifying Antibodies using for companies and may also be available
email ncitechtransfer@mail.nih.gov. A PBS’’ for licensing and/or co-development.
signed Confidential Disclosure HHS Ref. No. E–291–2014/0–PCT–03, ADDRESSES: Invention Development and
Agreement may be required to receive corresponding to International Patent Marketing Unit, Technology Transfer
copies of the patent applications. App. No. PCT/US2015/042241, filed Center, National Cancer Institute, 9609
jstallworth on DSK7TPTVN1PROD with NOTICES
SUPPLEMENTARY INFORMATION: July 27, 2015, entitled ‘‘Method for Medical Center Drive, Mail Stop 9702,
Technology description follows. Purifying Antibodies’’ Rockville, MD 20850–9702.
Title of invention: Method for Publications: FOR FURTHER INFORMATION CONTACT:
Purifying Antibodies. 1. FDA published document: http:// Information on licensing and co-
Description of Technology: This www.accessdata.fda.gov/drugsatfda_ development research collaborations,
technology is a method for purifying a docs/nda/2015/ and copies of the U.S. patent
biologic composition, comprising 125516Orig1s000TOC.cfm applications listed below may be
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Document Created: 2018-02-07 15:05:23
Document Modified: 2018-02-07 15:05:23
| 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 | Comments regarding this information collection are best assured of having their full effect if received within 30 days of the date of this publication. | |
| FR Citation | 81 FR 30541 |
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