81 FR 8208 - Agency Information Collection Activities; Submission to OMB for Review and Approval; Public Comment Request
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary Federal Register Volume 81, Issue 32 (February 18, 2016)
Office of the Secretary
Federal Register Volume 81, Issue 32 (February 18, 2016)
| Page Range | 8208-8209 | |
| FR Document | 2016-03249 |
[Federal Register Volume 81, Number 32 (Thursday, February 18, 2016)] [Notices] [Pages 8208-8209] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-03249] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the Secretary [Document Identifier OS-4040-0005 60D] Agency Information Collection Activities; Submission to OMB for Review and Approval; Public Comment Request AGENCY: Electronic Government Office, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: In compliance with section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Electronic Government Office (EGOV), Department of Health and Human Services, has submitted an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB) for review and approval. The ICR is for a 3-year extension for OMB Control Number 4040-0005. The ICR will expire on July 31, 2016. The ICR also requests categorizing the form as a common form, meaning HHS will only request approval for its own use of the form rather than aggregating the burden estimate across all Federal Agencies as was done for previous actions on this OMB control number. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public on this ICR during the review and approval period. DATES: Comments on the ICR must be received on or before April 18, 2016. [[Page 8209]] ADDRESSES: Submit your comments to [email protected] or (202) 690- 7569. FOR FURTHER INFORMATION CONTACT: Information Collection Clearance staff, [email protected] or (202) 690-6162. SUPPLEMENTARY INFORMATION: When submitting comments or requesting information, please include the OMB control number 4040-0005. Form is available http://www.grants.gov or upon request. Information Collection Request Title: SF-424 Application for Federal Assistance--Individual. OMB No.: 4040-0005. Abstract: The SF-424 Application for Federal Assistance--Individual is a common form used by Federal grant-making agencies for individual applicants without DUNS numbers to apply for Federal financial assistance. Need and Proposed Use of the Information: The SF-424 Application for Federal Assistance--The Individual common form is used by individuals not associated with organizations to apply for Federal financial assistance in the form of grants. These forms are submitted to the Federal grant-making agencies for evaluation and review. Likely Respondents: Organizations and institutions seeking grants. Burden Statement: Burden in this context means the time expended by persons to generate, maintain, retain, disclose or provide the information requested. This includes the time needed to review instructions, to develop, acquire, install and utilize technology and systems for the purpose of collecting, validating and verifying information, processing and maintaining information, and disclosing and providing information, to train personnel and to be able to respond to a collection of information, to search data sources, to complete and review the collection of information, and to transmit or otherwise disclose the information. The total annual burden hours estimated for this ICR are summarized in the table below. HHS does not use the form; however, HHS estimates that the SF-424 Application for Federal Assistance--Individual's will take 1 hour to complete. Once OMB approves the use of this common form, federal agencies may request OMB approval to use this common form without having to publish notices and request public comments for 60 and 30 days. Each agency must account for the burden associated with their use of the common form. EGOV specifically requests comments on (1) the necessity and utility of the proposed information collection for the proper performance of the agency's functions, (2) the accuracy of the estimated burden, (3) ways to enhance the quality, utility, and clarity of the information to be collected, and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden. Total Estimated Annualized Burden Hours ---------------------------------------------------------------------------------------------------------------- Number of Average burden Form name Number of responses per per response Total burden respondents respondent (in hours) hours ---------------------------------------------------------------------------------------------------------------- SF-424 Application for Federal Assistance-- 0 1 1 0 Individual..................................... --------------------------------------------------------------- Total....................................... 0 .............. .............. 0 ---------------------------------------------------------------------------------------------------------------- Terry S. Clark, Asst Information Collection Clearance Officer. [FR Doc. 2016-03249 Filed 2-17-16; 8:45 am] BILLING CODE 4150-57-P
![8208 Federal Register / Vol. 81, No. 32 / Thursday, February 18, 2016 / Notices
C. Gastroenterology and Urology I. Neurological Devices Panel more individuals to serve as a nonvoting
Devices Panel Reviews and evaluates data industry representative. Contact
concerning the safety and effectiveness information, a current curriculum vitae,
Reviews and evaluates data and the name of the Committee of
concerning the safety and effectiveness of marketed and investigational devices
for use in the neurological system and interest may be submitted to the FDA
of marketed and investigational Advisory Committee Membership
gastroenterology, urology and makes appropriate recommendations to
the Commissioner of Food and Drugs. Nomination Portal (see ADDRESSES)
nephrology devices and makes within 30 days of publication of this
appropriate recommendations to the J. Orthopaedic and Rehabilitation document (see DATES). FDA will forward
Commissioner of Food and Drugs. Devices Panel all nominations to the organizations
D. General and Plastic Surgery Devices Reviews and evaluates data expressing interest in participating in
Panel concerning the safety and effectiveness the selection process for the particular
of marketed and investigational device panel. (Persons who nominate
Reviews and evaluates data orthopedic and rehabilitation devices themselves as nonvoting industry
concerning the safety and effectiveness and makes appropriate representatives will not participate in
of marketed and investigational general recommendations to the Commissioner the selection process).
and plastic surgery devices and makes of Food and Drugs. This notice is issued under the
appropriate recommendations to the Federal Advisory Committee Act (5
Commissioner of Food and Drugs. K. Radiological Devices Panel U.S.C. app. 2) and 21 CFR part 14,
Reviews and evaluates data relating to advisory committees.
E. Hematology and Pathology Devices
Panel concerning the safety and effectiveness Dated: February 11, 2016.
of marketed and investigational Jill Hartzler Warner,
Reviews and evaluates data diagnostics or therapeutic radiological Associate Commissioner for Special Medical
concerning the safety and effectiveness and nuclear medicine devices and Programs.
of marketed and investigational in vitro makes appropriate recommendations to [FR Doc. 2016–03283 Filed 2–17–16; 8:45 am]
devices for use in clinical laboratory the Commissioner of Food and Drugs.
BILLING CODE 4164–01–P
medicine including pathology, II. Qualifications
hematology, histopathology,
cytotechnology and molecular biology Persons nominated for the device
DEPARTMENT OF HEALTH AND
and makes appropriate panels should be full-time employees of
HUMAN SERVICES
recommendations to the Commissioner firms that manufacture products that
of Food and Drugs. would come before the panel, or Office of the Secretary
consulting firms that represent
F. Medical Devices Dispute Resolution manufacturers, or have similar [Document Identifier OS–4040–0005 60D]
Provides advice to the Center Director appropriate ties to industry.
Agency Information Collection
on complex or contested scientific III. Selection Procedure Activities; Submission to OMB for
issues between the FDA and medical Any industry organization interested Review and Approval; Public Comment
device sponsors, applicants, or in participating in the selection of an Request
manufacturers relating to specific appropriate nonvoting member to
products, marketing applications, AGENCY: Electronic Government Office,
represent industry interests should send HHS.
regulatory decisions and actions by a letter stating that interest to the FDA
FDA, and Agency guidance and ACTION: Notice.
contact (see FOR FURTHER INFORMATION
policies. The Panel makes CONTACT) within 30 days of publication SUMMARY: In compliance with section
recommendations on issues that are of this document (see DATES). Within the 3507(a)(1)(D) of the Paperwork
lacking resolution, are highly complex subsequent 30 days, FDA will send a Reduction Act of 1995, the Electronic
in nature, or result from challenges to letter to each organization that has Government Office (EGOV), Department
Agency decisions or actions. expressed an interest, attaching a of Health and Human Services, has
G. Microbiology Devices Panel complete list of all such organizations; submitted an Information Collection
and a list of all nominees along with Request (ICR), described below, to the
Reviews and evaluates data their current resumes. The letter will Office of Management and Budget
concerning the safety and effectiveness also state that it is the responsibility of (OMB) for review and approval. The ICR
of marketed and investigational in vitro the interested organizations to confer is for a 3-year extension for OMB
devices for use in clinical laboratory with one another and to select a Control Number 4040–0005. The ICR
medicine including microbiology, candidate, within 60 days after the will expire on July 31, 2016. The ICR
virology, and infectious disease and receipt of the FDA letter, to serve as the also requests categorizing the form as a
makes appropriate recommendations to nonvoting member to represent industry common form, meaning HHS will only
the Commissioner of Food and Drugs. interests for a particular device panel. request approval for its own use of the
The interested organizations are not form rather than aggregating the burden
H. Molecular and Clinical Genetics
bound by the list of nominees in estimate across all Federal Agencies as
Devices Panel
selecting a candidate. However, if no was done for previous actions on this
OMB control number. Comments
mstockstill on DSK4VPTVN1PROD with NOTICES
Reviews and evaluates data individual is selected within 60 days,
concerning the safety and effectiveness the Commissioner will select the submitted during the first public review
of marketed and investigational in vitro nonvoting member to represent industry of this ICR will be provided to OMB.
devices for use in clinical laboratory interests. OMB will accept further comments from
medicine including clinical and the public on this ICR during the review
molecular genetics and makes IV. Application Procedure and approval period.
appropriate recommendations to the Individuals may self nominate and/or DATES: Comments on the ICR must be
Commissioner of Food and Drugs. an organization may nominate one or received on or before April 18, 2016.
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![Federal Register / Vol. 81, No. 32 / Thursday, February 18, 2016 / Notices 8209
ADDRESSES: Submit your comments to associated with organizations to apply HHS does not use the form; however,
ed.calimag@hhs.gov or (202) 690–7569. for Federal financial assistance in the HHS estimates that the SF–424
FOR FURTHER INFORMATION CONTACT: form of grants. These forms are Application for Federal Assistance—
Information Collection Clearance staff, submitted to the Federal grant-making Individual’s will take 1 hour to
Information.CollectionClearance@ agencies for evaluation and review. complete.
hhs.gov or (202) 690–6162. Likely Respondents: Organizations
and institutions seeking grants. Once OMB approves the use of this
SUPPLEMENTARY INFORMATION: When Burden Statement: Burden in this common form, federal agencies may
submitting comments or requesting context means the time expended by request OMB approval to use this
information, please include the OMB persons to generate, maintain, retain, common form without having to publish
control number 4040–0005. Form is disclose or provide the information notices and request public comments for
available http://www.grants.gov or upon requested. This includes the time 60 and 30 days. Each agency must
request. needed to review instructions, to account for the burden associated with
Information Collection Request Title: develop, acquire, install and utilize their use of the common form.
SF–424 Application for Federal technology and systems for the purpose EGOV specifically requests comments
Assistance—Individual. of collecting, validating and verifying on (1) the necessity and utility of the
OMB No.: 4040–0005. information, processing and
proposed information collection for the
Abstract: The SF–424 Application for maintaining information, and disclosing
Federal Assistance—Individual is a proper performance of the agency’s
and providing information, to train
common form used by Federal grant- personnel and to be able to respond to functions, (2) the accuracy of the
making agencies for individual a collection of information, to search estimated burden, (3) ways to enhance
applicants without DUNS numbers to data sources, to complete and review the quality, utility, and clarity of the
apply for Federal financial assistance. the collection of information, and to information to be collected, and (4) the
Need and Proposed Use of the transmit or otherwise disclose the use of automated collection techniques
Information: The SF–424 Application information. The total annual burden or other forms of information
for Federal Assistance—The Individual hours estimated for this ICR are technology to minimize the information
common form is used by individuals not summarized in the table below. collection burden.
TOTAL ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of
Number of burden per Total
Form name responses per
respondents response burden hours
respondent (in hours)
SF–424 Application for Federal Assistance—Individual .................................. 0 1 1 0
Total .......................................................................................................... 0 ........................ ........................ 0
Terry S. Clark, applications, the disclosure of which and Research Support Awards, National
Asst Information Collection Clearance would constitute a clearly unwarranted Institutes of Health, HHS)
Officer. invasion of personal privacy. Dated: February 11, 2016.
[FR Doc. 2016–03249 Filed 2–17–16; 8:45 am] Name of Committee: National Institute on Melanie J. Gray,
BILLING CODE 4150–57–P Alcohol Abuse and Alcoholism Special Program Analyst, Office of Federal Advisory
Emphasis Panel; Multi-Site Randomized Committee Policy.
Controlled Clinical Trial Research Center on [FR Doc. 2016–03240 Filed 2–17–16; 8:45 am]
DEPARTMENT OF HEALTH AND Alcohol’s Health Effects (U10). BILLING CODE 4140–01–P
HUMAN SERVICES Date: March 29, 2016.
Time: 11:00 a.m. to 3:00 p.m.
National Institutes of Health Agenda: To review and evaluate grant DEPARTMENT OF HEALTH AND
applications.
National Institute on Alcohol Abuse HUMAN SERVICES
Place: National Institutes of Health—
and Alcoholism; Notice of Closed NIAAA, 5635 Fishers Lane, Conference Room National Institutes of Health
Meeting 2098, Rockville, MD 20892 (Telephone
Conference Call). National Institute of Mental Health;
Pursuant to section 10(d) of the Contact Person: Ranga Srinivas, Ph.D., Notice of Closed Meetings
Federal Advisory Committee Act, as Chief, Extramural Project Review Branch,
amended (5 U.S.C. App.), notice is National Institute on Alcohol Abuse and Pursuant to section 10(d) of the
hereby given of the following meeting. Alcoholism, National Institutes of Health, Federal Advisory Committee Act, as
5365 Fishers Lane, Room 2085, Rockville, amended (5 U.S.C. App.), notice is
The meeting will be closed to the MD 20852, (301) 451–2067, srinivar@
public in accordance with the hereby given of the following meetings.
mail.nih.gov.
mstockstill on DSK4VPTVN1PROD with NOTICES
provisions set forth in sections The meetings will be closed to the
(Catalogue of Federal Domestic Assistance
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Program Nos. 93.271, Alcohol Research
public in accordance with the
as amended. The grant applications and Career Development Awards for Scientists provisions set forth in sections
the discussions could disclose and Clinicians; 93.272, Alcohol National 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
confidential trade secrets or commercial Research Service Awards for Research as amended. The grant applications and
property such as patentable material, Training; 93.273, Alcohol Research Programs; the discussions could disclose
and personal information concerning 93.891, Alcohol Research Center Grants; confidential trade secrets or commercial
individuals associated with the grant 93.701, ARRA Related Biomedical Research property such as patentable material,
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Document Created: 2016-02-18 07:46:40
Document Modified: 2016-02-18 07:46:40
| 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 on the ICR must be received on or before April 18, 2016. | |
| Contact | Information Collection Clearance staff, [email protected] or (202) 690-6162. | |
| FR Citation | 81 FR 8208 |
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