83 FR 44891 - Agency Information Collection Request; 30-Day Public Comment Request

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Federal Register Volume 83, Issue 171 (September 4, 2018)

Page Range		44891-44892
FR Document		2018-19084

In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment.

Federal Register, Volume 83 Issue 171 (Tuesday, September 4, 2018)

[Federal Register Volume 83, Number 171 (Tuesday, September 4, 2018)]
[Notices]
[Pages 44891-44892]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-19084]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Document Identifier: OS-4040-0014]


Agency Information Collection Request; 30-Day Public Comment 
Request

AGENCY: Office of the Secretary, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: In compliance with the requirement of the Paperwork Reduction 
Act of 1995, the Office of the Secretary (OS), Department of Health and 
Human Services, is publishing the following summary of a proposed 
collection for public comment.

DATES: Comments on the ICR must be received on or before October 4, 
2018.

ADDRESSES: Submit your comments to [email protected] or via 
facsimile to (202) 395-5806.

FOR FURTHER INFORMATION CONTACT: Sherrette Funn, [email protected] 
or (202) 795-7714. When submitting comments or requesting information, 
please include the document identifier 4040-0014-30D and project title 
for reference.

SUPPLEMENTARY INFORMATION: Interested persons are invited to send 
comments regarding this burden estimate or any other aspect of this 
collection of information, including any of the following subjects: (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.
    Title of the Collections: Federal Financial Report (SF-425) and 
Federal Financial Report Attachment (SF-425A).
    Type of Collection: Extension.
    OMB No.: 4040-0014.
    Abstract: Federal Financial Report (SF-425) and Federal Financial 
Report Attachment (SF-425A) are OMB-approved collections (4040-0014). 
These information collections are used by grant awardees. The ICs 
expire on January 31, 2019. We are requesting a three-year clearance of 
these collections.

                                                            Estimated Annualized Burden Table
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                             Number of    Average burden
                     Forms                                  Type of respondent               Number of     responses per     hours per     Total burden
                                                                                            respondents     respondent       response          hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Federal Financial Report (SF-425)..............  Grant Applicant........................         100,000               1               1         100,000
Federal Financial Report Attachment (SF-425A)..  Grant Applicant........................         100,000               1               1         100,000
                                                                                         ---------------------------------------------------------------
    Total......................................  .......................................         200,000  ..............  ..............         200,000
--------------------------------------------------------------------------------------------------------------------------------------------------------



[[Page 44892]]

Terry Clark,
Office of the Secretary, Asst. Paperwork Reduction Act Reports 
Clearance Officer.
[FR Doc. 2018-19084 Filed 8-31-18; 8:45 am]
 BILLING CODE 4151-AE-P

Federal Register / Vol. 83, No. 171 / Tuesday, September 4, 2018 / Notices 44891

consumption, with the exception of certificates for food for human ACTION: Notice.
dietary supplements, medical foods, and consumption, with the exception of
foods for special dietary use. This notice dietary supplements, medical foods, and SUMMARY: In compliance with the
applies to foods such as produce, grains, foods for special dietary use: requirement of the Paperwork
processed foods, food additives, color Reduction Act of 1995, the Office of the
additives, food contact substances, TABLE 1—CFSAN FEES FOR FIRST, Secretary (OS), Department of Health
generally regarded as safe ingredients, SECOND, AND SUBSEQUENT EXPORT and Human Services, is publishing the
infant formula, and all other foods not CERTIFICATES following summary of a proposed
specifically excluded. Dietary collection for public comment.
supplements, medical foods, and foods Fee
Type of certificate
for special dietary use are excluded (dollars) DATES: Comments on the ICR must be
from this notice. received on or before October 4, 2018.
First certificate ...................... 175
II. Fees To Be Assessed for Export Second certificate for the ADDRESSES: Submit your comments to
Certificates same product(s) issued in OIRA_submission@omb.eop.gov or via
response to the same re- facsimile to (202) 395–5806.
CFSAN estimates the annual costs of quest ................................. 155
the export certification program for food Subsequent certificates for FOR FURTHER INFORMATION CONTACT:
for human consumption, with the the same product(s) Sherrette Funn, Sherrette.Funn@hhs.gov
exception of dietary supplements, issued in response to the or (202) 795–7714. When submitting
medical foods, and foods for special same request .................... 100
comments or requesting information,
dietary use, to be approximately
The fee for issuing the first export please include the document identifier
$975,000 per year for preparing and
certificate for food for human 4040–0014–30D and project title for
issuing export certificates. The costs are
consumption, with the exception of reference.
due to payroll and operating expenses.
Specifically, there are four cost dietary supplements, medical foods, and
SUPPLEMENTARY INFORMATION: Interested
categories for preparing and issuing foods for special dietary use, will be at
persons are invited to send comments
export certificates in general: (1) Direct the maximum allowable amount and
consistent with the export certification regarding this burden estimate or any
personnel for research, review, tracking, other aspect of this collection of
writing, and assembly; (2) an fees assessed since FY 1997 by other
FDA Centers that provide export information, including any of the
information technology system used for
certification for drugs and devices. It is following subjects: (1) The necessity and
tracking and processing certificates; (3)
also consistent with the export utility of the proposed information
billing and collection of fees; and (4)
certification fees assessed by the Center collection for the proper performance of
overhead and administrative support. In
fiscal year (FY) 2017 CFSAN issued for Veterinary Medicine (CVM) for the agency’s functions; (2) the accuracy
approximately 4,072 export certificates certificates for animal food, which CVM of the estimated burden; (3) ways to
for food for human consumption, with began assessing in FY 2016 because the enhance the quality, utility, and clarity
the exception of dietary supplements, FSMA amendments to section 801(e)(4) of the information to be collected; and
medical foods, and foods for special of the FD&C Act also apply to animal (4) the use of automated collection
dietary use. Because CFSAN has not food. The fees for issuing subsequent techniques or other forms of information
been charging fees for issuing these certificates continue to differ among the technology to minimize the information
export certificates, the program has been Centers, based on varying costs. collection burden.
covered by appropriated funds. Dated: August 28, 2018. Title of the Collections: Federal
As mentioned previously, FDA may Leslie Kux, Financial Report (SF–425) and Federal
charge up to $175 for each certificate. Associate Commissioner for Policy. Financial Report Attachment (SF–
Certificates for some of the foods that [FR Doc. 2018–19064 Filed 8–31–18; 8:45 am] 425A).
are the subject of this notice cost us BILLING CODE 4164–01–P
more than $175 to prepare. Subsequent Type of Collection: Extension.
certificates issued for the same OMB No.: 4040–0014.
product(s) in response to the same DEPARTMENT OF HEALTH AND Abstract: Federal Financial Report
request generally cost FDA less than HUMAN SERVICES (SF–425) and Federal Financial Report
$175 to prepare. The fee for all Attachment (SF–425A) are OMB-
[Document Identifier: OS–4040–0014]
subsequent certificates for the same
approved collections (4040–0014).
product(s) issued in response to the Agency Information Collection These information collections are used
same request reflects reduced FDA costs Request; 30-Day Public Comment by grant awardees. The ICs expire on
for preparing those certificates. Request
The following fees will be assessed January 31, 2019. We are requesting a
starting October 1, 2018, for export AGENCY: Office of the Secretary, HHS. three-year clearance of these collections.

ESTIMATED ANNUALIZED BURDEN TABLE
Number of Average
Type of Number of Total
sradovich on DSK3GMQ082PROD with NOTICES

Forms responses per burden hours
respondent respondents burden hours
respondent per response

Federal Financial Report (SF–425) ................................ Grant Applicant .. 100,000 1 1 100,000
Federal Financial Report Attachment (SF–425A) ........... Grant Applicant .. 100,000 1 1 100,000

Total ......................................................................... ............................ 200,000 ........................ ........................ 200,000

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44892 Federal Register / Vol. 83, No. 171 / Tuesday, September 4, 2018 / Notices

Terry Clark, Time: 8:00 a.m. to 6:00 p.m. DEPARTMENT OF HEALTH AND
Office of the Secretary, Asst. Paperwork Agenda: To review and evaluate grant HUMAN SERVICES
Reduction Act Reports Clearance Officer. applications.
[FR Doc. 2018–19084 Filed 8–31–18; 8:45 am] Place: The William F. Bolger Center, 9600 Substance Abuse and Mental Health
BILLING CODE 4151–AE–P Newbridge Drive, Potomac, MD 20854. Services Administration
Contact Person: Delia Tang, MD, Scientific
Review Officer, Research Programs Review Current List of HHS-Certified
DEPARTMENT OF HEALTH AND Branch, Division of Extramural Activities, Laboratories and Instrumented Initial
HUMAN SERVICES National Cancer Institute, NIH, 9609 Medical Testing Facilities Which Meet Minimum
Center Drive, Room 7W602, Bethesda, MD Standards To Engage in Urine Drug
National Institutes of Health 20892–9750, 240–276–6456, tangd@ Testing for Federal Agencies
mail.nih.gov.
National Cancer Institute; Notice of AGENCY: Substance Abuse and Mental
Name of Committee: National Cancer Health Services Administration, HHS.
Closed Meetings Institute Special Emphasis Panel; SEP–8: NCI
ACTION: Notice.
Pursuant to section 10(d) of the Clinical and Translational R21 and Omnibus
Federal Advisory Committee Act, as R03. SUMMARY: The Department of Health and
amended, notice is hereby given of the Date: November 1–2, 2018. Human Services (HHS) notifies federal
following meetings. Time: 6:00 a.m. to 4:00 p.m. agencies of the laboratories and
The meetings will be closed to the Agenda: To review and evaluate grant Instrumented Initial Testing Facilities
public in accordance with the applications. (IITF) currently certified to meet the
provisions set forth in sections Place: Bethesda Marriott Suites, 6711 standards of the Mandatory Guidelines
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Democracy Boulevard, Bethesda, MD 20817. for Federal Workplace Drug Testing
as amended. The grant applications and Contact Person: Reed A. Graves, Ph.D., Programs (Mandatory Guidelines).
the discussions could disclose Scientific Review Officer, Research A notice listing all currently HHS-
confidential trade secrets or commercial Technology and Contract Review Branch, certified laboratories and IITFs is
property such as patentable material, Division of Extramural Activities, National published in the Federal Register
and personal information concerning Cancer Institute, NIH, 9609 Medical Center during the first week of each month. If
individuals associated with grant Drive, Room 7W106, Bethesda, MD 20892–
any laboratory or IITF certification is
applications, the disclosure of which 9750, 240–276–6384, gravesr@mail.nih.gov.
suspended or revoked, the laboratory or
would constitute a clearly unwarranted Name of Committee: National Cancer IITF will be omitted from subsequent
invasion of personal privacy. Institute Special Emphasis Panel; HIV/AIDS lists until such time as it is restored to
and the Tumor Niche. full certification under the Mandatory
Name of Committee: National Cancer
Date: November 13, 2018. Guidelines.
Institute Special Emphasis Panel; SEP–6: NCI
Clinical and Translational R21 & Omnibus Time: 11:00 a.m. to 3:00 p.m. If any laboratory or IITF has
R03. Agenda: To review and evaluate grant withdrawn from the HHS National
Date: October 4, 2018. applications. Laboratory Certification Program (NLCP)
Time: 7:30 a.m. to 4:30 p.m. Place: National Cancer Institute, Shady during the past month, it will be listed
Agenda: To review and evaluate grant Grove, 9609 Medical Center Drive, Room at the end and will be omitted from the
applications. 7W618, Rockville, MD 20850 (Telephone
Place: Bethesda North Marriott Hotel &
monthly listing thereafter.
Conference Call). This notice is also available on the
Conference Center, 5701 Marinelli Road, Contact Person: Mukesh Kumar, Ph.D.,
Bethesda, MD 20852. internet at http://www.samhsa.gov/
Scientific Review Officer, Research Programs workplace.
Contact Person: Eduardo E. Chufan, Ph.D.,
Review Branch, Division of Extramural
Scientific Review Officer, Research FOR FURTHER INFORMATION CONTACT:
Technology and Contract Review Branch, Activities, National Cancer Institute, NIH,
9609 Medical Center Drive, Room 7W618, Charles LoDico, Division of Workplace
Division of Extramural Activities, National
Cancer Institute, NIH, 9609 Medical Center Bethesda, MD 20892–9750, 240–276–6611, Programs, SAMHSA/CSAP, 5600
Drive, Room 7W254, Bethesda, MD 20892– mukesh.kumar3@nih.gov. Fishers Lane, Room 16N02C, Rockville,
9750, 240–276–7975, chufanee@mail.nih.gov. (Catalogue of Federal Domestic Assistance
Maryland 20857; 240–276–2600 (voice).
Name of Committee: National Cancer Program Nos. 93.392, Cancer Construction; SUPPLEMENTARY INFORMATION: The
Institute Special Emphasis Panel; SEP–9: NCI 93.393, Cancer Cause and Prevention Department of Health and Human
Clinical and Translational R21 and Omnibus Research; 93.394, Cancer Detection and Services (HHS) notifies federal agencies
R03. Diagnosis Research; 93.395, Cancer of the laboratories and Instrumented
Date: October 23, 2018. Initial Testing Facilities (IITF) currently
Treatment Research; 93.396, Cancer Biology
Time: 10:00 a.m. to 5:00 p.m.
Research; 93.397, Cancer Centers Support; certified to meet the standards of the
Agenda: To review and evaluate grant
applications. 93.398, Cancer Research Manpower; 93.399, Mandatory Guidelines for Federal
Place: National Cancer Institute, Shady Cancer Control, National Institutes of Health, Workplace Drug Testing Programs
Grove, 9609 Medical Center Drive, Room HHS) (Mandatory Guidelines). The Mandatory
7W114, Rockville, MD 20850 (Telephone Guidelines were first published in the
Dated: August 28, 2018.
Conference Call). Federal Register on April 11, 1988 (53
Contact Person: Jeffrey E. DeClue, Ph.D., Melanie J. Pantoja, FR 11970), and subsequently revised in
Scientific Review Officer, Research Program Analyst, Office of Federal Advisory the Federal Register on June 9, 1994 (59
Technology and Contract Review Branch, Committee Policy.
sradovich on DSK3GMQ082PROD with NOTICES

FR 29908); September 30, 1997 (62 FR
Division of Extramural Activities, National
Cancer Institute, NIH, 9609 Medical Center
[FR Doc. 2018–19051 Filed 8–31–18; 8:45 am] 51118); April 13, 2004 (69 FR 19644);
Drive, Room 7W114, Bethesda, MD 20892– BILLING CODE 4140–01–P November 25, 2008 (73 FR 71858);
9750, 240–276–6371, decluej@mail.nih.gov. December 10, 2008 (73 FR 75122); April
Name of Committee: National Cancer 30, 2010 (75 FR 22809); and on January
Institute Initial Review Group; Subcommittee 23, 2017 (82 FR 7920).
I—Transition to Independence. The Mandatory Guidelines were
Date: October 24–25, 2018. initially developed in accordance with

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Document Created: 2018-09-01 03:00:02
Document Modified: 2018-09-01 03:00:02

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 October 4, 2018.
Contact		Sherrette Funn, [email protected] or (202) 795-7714. When submitting comments or requesting information, please include the document identifier 4040-0014-30D and project title for reference.
FR Citation		83 FR 44891