80 FR 75120 - Proposed Collection; 60-Day Comment Request: NIH Information Collection Forms To Support Genomic Data Sharing for Research Purposes (OD)
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health Federal Register Volume 80, Issue 230 (December 1, 2015)
National Institutes of Health
Federal Register Volume 80, Issue 230 (December 1, 2015)
| Page Range | 75120-75122 | |
| FR Document | 2015-30465 |
[Federal Register Volume 80, Number 230 (Tuesday, December 1, 2015)] [Notices] [Pages 75120-75122] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-30465] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Proposed Collection; 60-Day Comment Request: NIH Information Collection Forms To Support Genomic Data Sharing for Research Purposes (OD) SUMMARY: In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the Office of the Director, the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Written comments and/or suggestions from the public and affected agencies are invited to address one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the [[Page 75121]] methodology and assumptions used; (3) The quality, utility, and clarity of the information to be collected; and (4) Minimization of the burden of the collection of information from those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. To Submit Comments and For Further Information: To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: Dina N. Paltoo, Ph.D., MPH, Director, Genetics, Health, and Society Program, Office of Clinical Research and Bioethics Policy, Office of Science Policy, 6705 Rockledge Drive, Suite 750, Bethesda, MD 20892 or call non-toll-free number 301-496-9838 or Email your request, including your address to: [email protected]. Formal requests for additional plans and instruments must be requested in writing. DATES: Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication. Proposed Collection: National Institutes of Health Information Collection Forms to Support Genomic Data Sharing for Research Purposes--0925-0670--Expiration Data 03/31/2016--Revision--Office of the Director (OD), National Institutes of Health (NIH). Need and Use of Information Collection: Sharing research data supports the NIH mission and is essential to facilitate the translation of research results into knowledge, products, and procedures that improve human health. The NIH has longstanding policies to make a broad range of research data, including genomic data, publicly available in a timely manner from the research activities that it funds. Genomic research data sharing is an integral element of the NIH mission as it facilitates advances in our understanding of factors that influence health and disease, while also providing opportunities to accelerate research through the power of combining large and information-rich datasets. To promote robust sharing of human and non-human data from a wide range of large-scale genomic research and provide appropriate protections for research involving human data, the National Institutes of Health (NIH) issued the NIH Genomic Data Sharing Policy (GDS Policy). Human genomic data submissions and controlled-access are managed through a central data repository, the database of Genotypes and Phenotypes (dbGaP) which is administered by the National Center for Biotechnology Information (NCBI), part of the National Library of Medicine at NIH. Under the GDS Policy, all investigators who receive NIH funding to conduct large-scale genomic research are expected to register studies with human genomic data in dbGaP, no matter which NIH-designated data repository will maintain the data. As part of the registration process, investigators must provide basic study information such as the type of data that will be submitted to dbGaP, a description of the study, and an institutional assurance (i.e. Institutional Certification) of the data submission which delineates any limitations on the secondary use of the data (e.g., data cannot be shared with for-profit companies, data can be used only for research of particular diseases). Investigators interested in using controlled-access data for secondary research must apply through dbGaP and be granted permission from the relevant NIH Data Access Committee(s). As part of the application process, investigators and their institutions must provide information such as a description of the proposed research use of controlled-access datasets that conforms to any data use limitations, agree to the Genomic Data User Code of Conduct, and agree to the terms of access through a Data Use Certification agreement. Requests to renew data access and reports to close out data use are similar to the initial data access request, requiring sign-off by both the requestor and the institution, but also ask for information about how the data have been used, and about publications, presentations, or intellectual property based on the research conducted with the accessed data as well as any data security issues or other data management incidents. The NIH has developed online forms, available through dbGaP, in an effort to reduce the burden for researchers and their institutional officials to complete the study registration, data submission, data access, and renewal and closeout processes. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 2,505. Estimated Annualized Burden Hours ---------------------------------------------------------------------------------------------------------------- Number of Average time Type of form Number of responses per per response Total annual respondents respondent (in hours) burden hour ---------------------------------------------------------------------------------------------------------------- Study Registration and Data Submission ---------------------------------------------------------------------------------------------------------------- Investigator Submitting Data.................... 150 1 1 150 Institutional Official to Certify............... 150 1 30/60 75 ---------------------------------------------------------------------------------------------------------------- Initial Data Access Request ---------------------------------------------------------------------------------------------------------------- Investigator Requesting Data.................... 633 2 45/60 950 Signing Official to Certify..................... 633 2 30/60 633 ---------------------------------------------------------------------------------------------------------------- Renewal and Close-out of Data Access ---------------------------------------------------------------------------------------------------------------- Investigator Requesting Data.................... 633 2 15/60 317 Signing Official to Certify..................... 633 2 18/60 380 ---------------------------------------------------------------------------------------------------------------- [[Page 75122]] Dated: November 23, 2015. Lawrence A. Tabak, Deputy Director, National Institutes of Health. [FR Doc. 2015-30465 Filed 11-30-15; 8:45 am] BILLING CODE 4140-01-P
![75120 Federal Register / Vol. 80, No. 230 / Tuesday, December 1, 2015 / Notices
http://www.regulations.gov or at the Pl., Rockville, MD 20855, 240–402– rights for any person and is not binding
Division of Dockets Management 5944, dragan.momcilovic@fda.hhs.gov. on FDA or the public. You can use an
between 9 a.m. and 4 p.m., Monday SUPPLEMENTARY INFORMATION: alternative approach if it satisfies the
through Friday. requirements of the applicable statutes
I. Background and regulations.
• Confidential Submissions—To
submit a comment with confidential FDA is announcing the availability of
a draft guidance for industry #233 III. Paperwork Reduction Act of 1995
information that you do not wish to be
made publicly available, submit your entitled ‘‘Veterinary Feed Directive This draft guidance refers to
comments only as a written/paper Common Format Questions and previously approved collections of
submission. You should submit two Answers.’’ information found in FDA regulations.
In 1996, Congress enacted the Animal These collections of information are
copies total. One copy will include the
Drug Availability Act (ADAA) to subject to review by the Office of
information you claim to be confidential
facilitate the approval and marketing of Management and Budget (OMB) under
with a heading or cover note that states
new animal drugs and medicated feeds. the Paperwork Reduction Act of 1995
‘‘THIS DOCUMENT CONTAINS
In passing the ADAA, Congress created (44 U.S.C. 3501–3520). The collections
CONFIDENTIAL INFORMATION.’’ The
a new regulatory category for certain of information in § 514.1 have been
Agency will review this copy, including
animal drugs used in or on animal feed approved under OMB control number
the claimed confidential information, in
called VFD drugs. VFD drugs are new 0910–0032. The collections of
its consideration of comments. The
animal drugs intended for use in or on information in § 558.6 have been
second copy, which will have the
animal feed which are limited to use approved under OMB control number
claimed confidential information under the professional supervision of a
redacted/blacked out, will be available 0910–0363.
licensed veterinarian. FDA published
for public viewing and posted on final regulations at § 558.6 (21 CFR IV. Electronic Access
http://www.regulations.gov. Submit 558.6) implementing the VFD-related Persons with access to the Internet
both copies to the Division of Dockets provisions of the ADAA in 2000. On may obtain the draft guidance at either
Management. If you do not wish your June 3, 2015 (80 FR 31707), FDA http://www.fda.gov/AnimalVeterinary/
name and contact information to be published a VFD final rule that revised GuidanceComplianceEnforcement/
made publicly available, you can those VFD regulations and introduced GuidanceforIndustry/default.htm or
provide this information on the cover clarifying changes to specified http://www.regulations.gov.
sheet and not in the body of your definitions.
comments and you must identify this Dated: November 25, 2015.
During the latest rulemaking process,
information as ‘‘confidential.’’ Any Leslie Kux,
FDA received a few comments
information marked as ‘‘confidential’’ requesting the Agency to require a Associate Commissioner for Policy.
will not be disclosed except in uniform VFD format. We declined this [FR Doc. 2015–30411 Filed 11–30–15; 8:45 am]
accordance with 21 CFR 10.20 and other request because we thought that BILLING CODE 4164–01–P
applicable disclosure law. For more requiring a specific format would be too
information about FDA’s posting of prescriptive. However, we acknowledge
comments to public dockets, see 80 FR that a common VFD format would help DEPARTMENT OF HEALTH AND
56469, September 18, 2015, or access clients, veterinarians, and distributors HUMAN SERVICES
the information at: http://www.fda.gov/ (including feed mills) quickly identify
regulatoryinformation/dockets/ National Institutes of Health
relevant information on the VFD.
default.htm. We are issuing this draft guidance to Proposed Collection; 60-Day Comment
Docket: For access to the docket to recommend a common VFD format. In Request: NIH Information Collection
read background documents or the the draft guidance, we use the term Forms To Support Genomic Data
electronic and written/paper comments ‘‘VFD’’ to refer to the form used to Sharing for Research Purposes (OD)
received, go to http:// convey the VFD order. This draft
www.regulations.gov and insert the guidance describes the requirements in SUMMARY: In compliance with the
docket number, found in brackets in the § 514.1(b)(9) (21 CFR 514.1(b)(9)) for requirement of Section 3506(c)(2)(A) of
heading of this document, into the sponsor submission of a VFD to FDA as the Paperwork Reduction Act of 1995,
‘‘Search’’ box and follow the prompts part of the application process for for opportunity for public comment on
and/or go to the Division of Dockets approval of a new animal drug for use proposed data collection projects, the
Management, 5630 Fishers Lane, Rm. in or on animal feed as a VFD drug, as Office of the Director, the National
1061, Rockville, MD 20852. well as the required and optional Institutes of Health (NIH) will publish
information to be included on the VFD. periodic summaries of proposed
Submit written requests for single
This draft guidance provides examples projects to be submitted to the Office of
copies of the draft guidance to the
that illustrate how a common VFD Management and Budget (OMB) for
Policy and Regulations Staff (HFV–6),
format might appear and how some of review and approval.
Center for Veterinary Medicine, Food
the information on the VFD may be Written comments and/or suggestions
and Drug Administration, 7519 Standish
prepopulated by a sponsor. from the public and affected agencies
Pl., Rockville, MD 20855. Send one self-
are invited to address one or more of the
addressed adhesive label to assist that II. Significance of Guidance following points: (1) Whether the
office in processing your requests. See
This level 1 draft guidance is being proposed collection of information is
the SUPPLEMENTARY INFORMATION section
tkelley on DSK3SPTVN1PROD with NOTICES
issued consistent with FDA’s good necessary for the proper performance of
for electronic access to the draft guidance practices regulation (21 CFR the function of the agency, including
guidance document. 10.115). The draft guidance, when whether the information will have
FOR FURTHER INFORMATION CONTACT: finalized, will represent the current practical utility; (2) The accuracy of the
Dragan Momcilovic, Center for thinking of FDA on ‘‘Veterinary Feed agency’s estimate of the burden of the
Veterinary Medicine (HFV–226), Food Directive Common Format Questions proposed collection of information,
and Drug Administration, 7519 Standish and Answers.’’ It does not establish any including the validity of the
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![75122 Federal Register / Vol. 80, No. 230 / Tuesday, December 1, 2015 / Notices
Dated: November 23, 2015. Name of Committee: Center for Scientific DEPARTMENT OF HEALTH AND
Lawrence A. Tabak, Review Special Emphasis Panel; Member HUMAN SERVICES
Conflict: Cardiovascular Sciences.
Deputy Director, National Institutes of Health.
Date: December 9–10, 2015. Substance Abuse and Mental Health
[FR Doc. 2015–30465 Filed 11–30–15; 8:45 am] Time: 8:00 a.m. to 4:00 p.m. Services Administration
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A notice listing all currently HHS-
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Conflicts and Continuous Submissions. days prior to the meeting due to the timing certified laboratories and IITFs is
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Agenda: To review and evaluate grant Name of Committee: Center for Scientific any laboratory or IITF certification is
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(Virtual Meeting). Time: 11:30 a.m. to 12:30 p.m. full certification under the Mandatory
Contact Person: Chee Lim, Center for Agenda: To review and evaluate grant Guidelines.
Scientific Review, National Institutes of applications. If any laboratory or IITF has
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funding cycle. 1051, One Choke Cherry Road,
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Ph.D., Chief, CVRS IRG, Center for Scientific developed in accordance with Executive
Institutes of Health, HHS)
Review, National Institutes of Health, 6701
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This notice is being published less than 15 Program Analyst, Office of Federal Advisory Programs,’’ as amended in the revisions
Committee Policy. listed above, requires strict standards
days prior to the meeting due to the timing
limitations imposed by the review and [FR Doc. 2015–30351 Filed 11–30–15; 8:45 am] that laboratories and IITFs must meet in
funding cycle. BILLING CODE 4140–01–P order to conduct drug and specimen
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Document Created: 2018-03-02 09:10:33
Document Modified: 2018-03-02 09:10:33
| 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 | Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication. | |
| FR Citation | 80 FR 75120 |
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