82 FR 41035 - Food Safety Modernization Act Third-Party Certification Program User Fee Rate for Fiscal Year 2018
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 166 (August 29, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 166 (August 29, 2017)
| Page Range | 41035-41038 | |
| FR Document | 2017-18222 |
[Federal Register Volume 82, Number 166 (Tuesday, August 29, 2017)] [Notices] [Pages 41035-41038] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-18222] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-N-4119] Food Safety Modernization Act Third-Party Certification Program User Fee Rate for Fiscal Year 2018 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing the fiscal year (FY) 2018 annual fee rate for recognized accreditation bodies and accredited certification bodies, and the fee rate for accreditation bodies applying to be recognized in the third-party certification program that is authorized by the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the FDA Food Safety Modernization Act (FSMA). FOR FURTHER INFORMATION CONTACT: Donald Prater, Office of Foods and Veterinary Medicine, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 3234, Silver Spring, MD 20993, 301-348-3007. DATES: This fee is effective October 1, 2017. SUPPLEMENTARY INFORMATION: I. Background Section 307 of FSMA, Accreditation of Third-Party Auditors, amended the FD&C Act to create a new provision, section 808, under the same name. Section 808 of the FD&C Act (21 U.S.C. 384d) directs FDA to establish a program for accreditation of third-party certification bodies \1\ conducting food safety audits and issuing food and facility certifications to eligible foreign entities (including registered foreign food facilities) that meet our applicable requirements. Under this provision, we established a system for FDA to recognize accreditation bodies to accredit certification bodies, except for limited circumstances in which we may directly accredit certification bodies to participate in the third-party certification program. --------------------------------------------------------------------------- \1\ For the reasons explained in the third-party certification final rule (80 FR 74570 at 74578-74579, November 27, 2015), and for consistency with the implementing regulations for the third-party certification program in 21 CFR parts 1, 11, and 16, this notice uses the term ``third-party certification body'' rather than the term ``third-party auditor'' used in section 808(a)(3) of the FD&C Act. --------------------------------------------------------------------------- Section 808(c)(8) of the FD&C Act directs FDA to establish a reimbursement (user fee) program by which we assess fees and require reimbursement for the work FDA performs to establish and administer the third-party certification program under section 808 of the FD&C Act. The user fee program for the third-party certification program was established by a final rule entitled ``Amendments to Accreditation of Third-Party Certification Bodies to Conduct Food Safety Audits and To Issue Certifications to Provide for the User Fee Program'' (81 FR 90186, December 14, 2016). The FSMA FY 2018 third-party certification program user fee rate announced in this notice is effective on October 1, 2017, and will remain in effect through September 30, 2018. II. Estimating the Average Cost of a Supported Direct FDA Work Hour for FY 2018 In each year, the costs of salary (or personnel compensation) and benefits for FDA employees account for between 50 and 60 percent of the funds available to, and used by, FDA. Almost all of the remaining funds (operating funds) available to FDA are used to support FDA employees for paying rent, travel, utility, information technology, and other operating costs. A. Estimating the Full Cost per Direct Work Hour in FY 2018 Full-time Equivalent (FTE) reflects the total number of regular straight-time hours--not including overtime or holiday hours--worked by employees, [[Page 41036]] divided by the number of compensable hours applicable to each fiscal year. Annual leave, sick leave, compensatory time off, and other approved leave categories are considered ``hours worked'' for purposes of defining FTE employment. In general, the starting point for estimating the full cost per direct work hour is to estimate the cost of an FTE or paid staff year. Calculating an Agency-wide total cost per FTE requires three primary cost elements: Payroll, non-payroll, and rent. We have used an average of past year cost elements to predict the FY 2018 cost. The FY 2018 FDA-wide average cost for payroll (salaries and benefits) is $154,638; non-payroll--including equipment, supplies, IT, general and administrative overhead--is $89,224; and rent, including cost allocation analysis and adjustments for other rent and rent-related costs, is $23,922 per paid staff year, excluding travel costs. Summing the average cost of an FTE for payroll, non-payroll, and rent, brings the FY 2018 average fully supported cost to $267,783 per FTE, excluding travel costs. FDA will use this base unit fee in determining the hourly fee rate for third party certification user fees for FY 2018 prior to including travel costs as applicable for the activity. To calculate an hourly rate, FDA must divide the FY 2018 average fully supported cost of $267,783 per FTE by the average number of supported direct FDA work hours in FY 2016--the last FY for which data are available. See table 1. Table 1--Supported Direct FDA Work Hours in a Paid Staff Year in FY 2016 ------------------------------------------------------------------------ ------------------------------------------------------------------------ Total Number of Hours in a Paid Staff Year................... 2,080 Less: 10 paid holidays......................................... -80 20 days of annual leave.................................. -160 10 days of sick leave.................................... -80 12.5 days of training.................................... -100 26.5 days of general administration...................... -184 26.5 days of travel...................................... -212 2 hours of meetings per week............................. -104 ---------- Net Supported Direct FDA Work Hours Available for =1,160 Assignments......................................... ------------------------------------------------------------------------ Dividing the average fully supported FTE cost in FY 2018 ($267,783) by the total number of supported direct work hours available for assignment in FY 2016 (1,160) results in an average fully supported cost of $231 (rounded to the nearest dollar), excluding travel costs, per supported direct work hour in FY 2018. B. Adjusting FY 2016 Travel Costs for Inflation To Estimate FY 2018 Travel Costs To adjust the hourly rate for FY 2018, FDA must estimate the cost of inflation in each year for FY 2017 and FY 2018. FDA uses the method prescribed for estimating inflationary costs under the Prescription Drug User Fee Act (PDUFA) provisions of the FD&C Act (section 736(c)(1) (21 U.S.C. 379h(c)(1)), the statutory method for inflation adjustment in the FD&C Act that FDA has used consistently. FDA previously determined the FY 2017 inflation rate to be 1.5468 percent; this rate was published in the FY2017 PDUFA user fee rates notice in the Federal Register. Utilizing the method set forth in section 736(c)(1) of the FD&C Act, FDA has calculated an inflation rate of 1.5468 percent for FY 2017 and 1.6868 percent for FY 2018 and FDA intends to use this inflation rate to make inflation adjustments for FY 2018 for several of its user fee programs; the derivation of this rate will be published in the Federal Register in the FY 2018 notice for the PDUFA user fee rates. The compounded inflation rate for FYs 2017 and 2018, therefore, is 1.032597 (or 3.2597 percent) (1 plus 1.5468 percent times 1 plus 1.6868 percent). The average fully supported cost per supported direct FDA work hour, excluding travel costs, of $231 already takes into account inflation as the calculation above is based on FY 2018 predicted costs. FDA will use this base unit fee in determining the hourly fee rate for third-party certification program fees for FY 2018 prior to including travel costs as applicable for the activity. For the purpose of estimating the fee, we are using the travel cost rate for foreign travel because we anticipate that the vast majority of onsite assessments made by FDA under this program will require foreign travel. In FY 2016, the Office of Regulatory Affairs spent a total of $2,166,592 on 344.31 foreign inspection trips related to FDA's Center for Food Safety and Applied Nutrition and Center for Veterinary Medicine field activities programs, which averaged a total of $6,293 per foreign inspection trip. These trips averaged 3 weeks (or 120 paid hours) per trip. Dividing $6,293 per trip by 120 hours per trip results in a total and an additional cost of $52 (rounded to the nearest dollar) per paid hour spent for foreign inspection travel costs in FY 2016. To adjust $52 for inflationary increases in FY 2017 and FY 2018, FDA must multiply it by the same inflation factor mentioned previously in this document (1.032597 or 3.2597 percent), which results in an estimated cost of $54 (rounded to the nearest dollar) per paid hour in addition to $231 for a total of $285 per paid hour ($231 plus $54) for each direct hour of work requiring foreign inspection travel. FDA will use these rates in charging fees in FY 2018 when travel is required for the third-party certification program. Table 2--FSMA Fee Schedule for FY 2018 ------------------------------------------------------------------------ Fee rates for Fee category FY 2018 ------------------------------------------------------------------------ Hourly rate without travel.............................. $231 Hourly rate if travel is required....................... 285 ------------------------------------------------------------------------ III. Fees for Accreditation Bodies and Certification Bodies in the Third-Party Certification Program Under Section 808(c)(8) of the FD&C Act The third-party certification program assesses application fees and annual fees. In FY18, the only fees that will be collected by FDA under section 808(c)(8) of the FD&C Act are the initial application fee for accreditation bodies seeking recognition, the annual fee for recognized accreditation bodies, and the annual fee for certification bodies accredited by a recognized accreditation body. Table 3 provides an overview of the fees for FY 2018. Table 3--FSMA Third-Party Certification Program User Fee Schedule for FY 2018 ------------------------------------------------------------------------ Fee rates for Fee category FY 2018 ------------------------------------------------------------------------ Initial Application Fee for Accreditation Body Seeking $37,935 Recognition............................................ Annual Fee for Recognized Accreditation Body............ 1,752 Annual Fee for Accredited Certification Body............ 2,190 ------------------------------------------------------------------------ A. Application Fee for Accreditation Bodies Applying for Recognition in the Third-Party Certification Program Under Section 808(c)(8) of the FD&C Act Section 1.705(a)(1) (21 CFR 1.705(a)(1)) establishes an application fee for accreditation bodies applying for initial recognition that represents the estimated average cost of the work FDA performs in reviewing and evaluating initial applications for recognition of accreditation bodies. The fee is based on the fully supported FTE hourly rates and estimates of the number of hours it [[Page 41037]] would take FDA to perform relevant activities. These estimates represent FDA's current thinking, and as the program evolves, FDA will reconsider the estimated hours. We estimate that it would take, on average, 60 person-hours to review an accreditation body's submitted application, 48 person-hours for an onsite performance evaluation of the applicant (including travel and other steps necessary for a fully supported FTE to complete an onsite assessment), and 45 person-hours to prepare a written report documenting the onsite assessment. FDA employees are likely to review applications and prepare reports from their worksites, so we use the fully supported FTE hourly rate excluding travel, $231/hour, to calculate the portion of the user fee attributable to those activities: $231/hour x (60 hours + 45 hours) = $24,255. FDA employees will likely travel to foreign countries for the onsite performance evaluations because most accreditation bodies are located in foreign countries. For this portion of the fee we use the fully supported FTE hourly rate for work requiring travel, $285/hour, to calculate the portion of the user fee attributable to those activities: $285/hour x 48 hours (i.e., 2 fully supported FTEs x (2 travel days + 1 day onsite)) = $13,680. The estimated average cost of the work FDA performs in total for reviewing an initial application for recognition for an accreditation body based on these figures would be $24,255 + $13,680 = $37,935. Therefore the application fee for accreditation bodies applying for recognition in FY 2018 will be $37,935. B. Annual Fee for Accreditation Bodies Participating in the Third-Party Certification Program Under Section 808(c)(8) of the FD&C Act To calculate the annual fee for each recognized accreditation body, FDA takes the estimated average cost of work FDA performs to monitor performance of a single recognized accreditation body and annualizes that over the average term of recognition. At this time we assume an average term of recognition of 5 years. We also assume that FDA will monitor 10 percent of recognized accreditation bodies onsite. As the program proceeds, we will adjust the term of recognition as appropriate. We estimate that for one performance evaluation of a recognized accreditation body, it would take, on average (taking into account that not all recognized accreditation bodies would be monitored onsite), 24 hours for FDA to conduct records review, 8 hours to prepare a report detailing the records review and onsite performance evaluation, and 4.8 hours of onsite performance evaluation (i.e., 10 percent x 2 fully supported FTEs x (2 travel days + 2 day onsite)). Using the fully supported FTE hourly rates in table 2, the estimated average cost of the work FDA performs to monitor performance of a single recognized accreditation body would be $7,392 ($231/hour x (24 hours + 8 hours)) plus $1,368 ($285/hour x 4.8 hours), which is $8,760. Annualizing this amount over 5 years would lead to an annual fee for recognized accreditation bodies of $1,752 for FY 2018. C. Annual Fee for Certification Bodies Accredited by a Recognized Accreditation Body in the Third-Party Certification Program Under Section 808(c)(8) of the FD&C Act To calculate the annual fee for a certification body accredited by a recognized accreditation body, FDA takes the estimated average cost of work FDA performs to monitor performance of a single certification body accredited by a recognized accreditation body and annualizes that over the average term of accreditation. At this time we assume an average term of accreditation of 4 years. This fee is based on the fully supported FTE hourly rates and estimates of the number of hours it would take FDA to perform relevant activities. We estimate that FDA would conduct, on average, the same activities, for the same amount of time to monitor certification bodies accredited by a recognized accreditation body as we would to monitor an accreditation body recognized by FDA. Using the fully supported FTE hourly rates in table 2, the estimated average cost of the work FDA performs to monitor performance of a single accredited certification body would be $7,392 ($231/hour x (24 hours + 8 hours)) plus $1,368 ($285/hour x 4.8 hours), which is $8,760. Annualizing this amount over 4 years would lead to an annual fee for accredited certification bodies of $2,190 for FY 2018. IV. Estimated Fees for Accreditation Bodies and Certification Bodies in Other Fee Categories for FY 2018 Section 1.705(a) also establishes application fees for recognized accreditation bodies submitting renewal applications, certification bodies applying for direct accreditation, and certification bodies applying for renewal of direct accreditation. Section 1.705(b) establishes annual fees for recognized accreditation bodies, certification bodies directly accredited by FDA, and certification bodies accredited by recognized accreditation bodies. Although we will not be collecting all of these other fees in FY 2018, for transparency and planning purposes, we have provided an estimate of what these fees would be for FY 2018 based on the fully supported FTE hourly rates for FY 2018 and estimates of the number of hours it would take FDA to perform relevant activities as outlined in the Final Regulatory Impact Analysis for the Third-Party Certification Regulation. Table 4 provides an overview of the estimated fees for other fee categories. Table 4--Estimated Fee Rates for Other Fee Categories Under the FSMA Third-Party Certification Program ------------------------------------------------------------------------ Estimated fee Fee category rates for FY 2018 ------------------------------------------------------------------------ Renewal application fee for recognized accreditation $21,049 body................................................... Initial application fee for certification body seeking 37,935 direct-accreditation from FDA.......................... Renewal application fee for directly-accredited 28,755 certification body..................................... Annual fee for certification body directly-accredited by 21,072 FDA.................................................... ------------------------------------------------------------------------ V. How must the fee be paid? Accreditation bodies seeking initial recognition must submit the application fee with the application. For recognized accreditation bodies and accredited certification bodies, an invoice will be sent annually. Payment must be made within 30 days of the invoice date. Detailed payment information will be included with the invoice when it is issued. VI. What are the consequences of not paying this fee? The consequences of not paying these fees are outlined in Sec. 1.725. If FDA does not receive an application fee with an application for recognition, the application will be considered incomplete and FDA will not review the application. If a recognized accreditation body fails to submit its annual user fee within 30 days of the due date, we will suspend its recognition. If the recognized accreditation body fails to submit its annual user fee within 90 days of the due date, we will revoke its recognition. If an accredited certification body fails to pay its annual fee within 30 days of the due date, we will suspend its accreditation. If the accredited certification body fails to pay its annual [[Page 41038]] fee within 90 days of the due date, we will withdraw its accreditation. Dated: August 23, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-18222 Filed 8-28-17; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 82, No. 166 / Tuesday, August 29, 2017 / Notices 41035
completed DFUF order) in your wire not to be used for questions related to FD&C Act to create a new provision,
transfer. Without the PIN, your payment other aspects of medical device user section 808, under the same name.
may not be applied to your facility and fees.) Problems with the BER system Section 808 of the FD&C Act (21 U.S.C.
your registration may be delayed. should be directed to https:// 384d) directs FDA to establish a
The originating financial institution www.accessdata.fda.gov/scripts/email/ program for accreditation of third-party
may charge a wire transfer fee. If the cber/bldregcontact.cfm or call 240–402– certification bodies 1 conducting food
financial institution charges a wire 8360. safety audits and issuing food and
transfer fee it is required that you add facility certifications to eligible foreign
that amount to the payment to ensure D. Enter Your DFUF Order PIN and PCN
entities (including registered foreign
that the invoice is paid in full. Use the After completing your annual or food facilities) that meet our applicable
following account information when initial registration and device listing, requirements. Under this provision, we
sending a wire transfer: U.S. Dept. of you will be prompted to enter your established a system for FDA to
Treasury, TREAS NYC, 33 Liberty St., DFUF order PIN and PCN, when recognize accreditation bodies to
New York, NY 10045, Acct. No. applicable. This process does not apply accredit certification bodies, except for
75060099, Routing No. 021030004, to establishments engaged only in the limited circumstances in which we may
SWIFT: FRNYUS33, Beneficiary: FDA, manufacture, preparation, propagation, directly accredit certification bodies to
8455 Colesville Rd., 14th Floor, Silver compounding, or processing of licensed participate in the third-party
Spring, MD 20993–0002. If needed, biologic devices. CBER will send certification program.
FDA’s tax identification number is 53– invoices for payment of the Section 808(c)(8) of the FD&C Act
0196965. establishment registration fee to such directs FDA to establish a
C. Complete the Information Online To establishments. reimbursement (user fee) program by
Update Your Establishment’s Annual Dated: August 24, 2017. which we assess fees and require
Registration for FY 2018, or To Register Anna K. Abram, reimbursement for the work FDA
a New Establishment for FY 2018 Deputy Commissioner for Policy, Planning, performs to establish and administer the
Legislation, and Analysis. third-party certification program under
Go to the Center for Devices and section 808 of the FD&C Act. The user
Radiological Health’s Web site at [FR Doc. 2017–18378 Filed 8–28–17; 8:45 am]
fee program for the third-party
https://www.fda.gov/MedicalDevices/ BILLING CODE 4164–01–P
certification program was established by
DeviceRegulationandGuidance/Howto
a final rule entitled ‘‘Amendments to
MarketYourDevice/Registrationand
DEPARTMENT OF HEALTH AND Accreditation of Third-Party
Listing/default.htm and click the
HUMAN SERVICES Certification Bodies to Conduct Food
‘‘Access Electronic Registration’’ link on
Safety Audits and To Issue
the left side of the page. This opens up
Food and Drug Administration Certifications to Provide for the User
a new page with important information
Fee Program’’ (81 FR 90186, December
about the FDA Unified Registration and [Docket No. FDA–2016–N–4119]
14, 2016).
Listing System (FURLS). After reading
Food Safety Modernization Act Third- The FSMA FY 2018 third-party
this information, click on the ‘‘Access
Party Certification Program User Fee certification program user fee rate
Electronic Registration’’ link in the
Rate for Fiscal Year 2018 announced in this notice is effective on
middle of the page. This link takes you
October 1, 2017, and will remain in
to an FDA Industry Systems page with
AGENCY: Food and Drug Administration, effect through September 30, 2018.
tutorials that demonstrate how to create
HHS.
a new FURLS user account if your II. Estimating the Average Cost of a
establishment did not create an account ACTION: Notice. Supported Direct FDA Work Hour for
in FY 2017. Manufacturers of licensed SUMMARY: The Food and Drug FY 2018
biologics should register in the BER Administration (FDA) is announcing the In each year, the costs of salary (or
system at https://www.fda.gov/Biologics fiscal year (FY) 2018 annual fee rate for personnel compensation) and benefits
BloodVaccines/GuidanceCompliance recognized accreditation bodies and for FDA employees account for between
RegulatoryInformation/Establishment accredited certification bodies, and the 50 and 60 percent of the funds available
Registration/BloodEstablishment fee rate for accreditation bodies to, and used by, FDA. Almost all of the
Registration/default.htm. applying to be recognized in the third-
Enter your existing account ID and remaining funds (operating funds)
party certification program that is available to FDA are used to support
password to log into FURLS. From the
authorized by the Federal Food, Drug, FDA employees for paying rent, travel,
FURLS/FDA Industry Systems menu,
and Cosmetic Act (the FD&C Act), as utility, information technology, and
click on the Device Registration and
amended by the FDA Food Safety other operating costs.
Listing Module (DRLM) of FURLS
Modernization Act (FSMA).
button. New establishments will need to A. Estimating the Full Cost per Direct
register and existing establishments will FOR FURTHER INFORMATION CONTACT:
Work Hour in FY 2018
update their annual registration using Donald Prater, Office of Foods and
Veterinary Medicine, Food and Drug Full-time Equivalent (FTE) reflects the
choices on the DRLM menu. When you total number of regular straight-time
choose to register or update your annual Administration, 10903 New Hampshire
Ave., Bldg. 1, Rm. 3234, Silver Spring, hours—not including overtime or
registration, the system will prompt you holiday hours—worked by employees,
through the entry of information about MD 20993, 301–348–3007.
sradovich on DSK3GMQ082PROD with NOTICES
your establishment and your devices. If DATES: This fee is effective October 1,
1 For the reasons explained in the third-party
you have any problems with this 2017. certification final rule (80 FR 74570 at 74578–
process, email: reglist@cdrh.fda.gov or SUPPLEMENTARY INFORMATION: 74579, November 27, 2015), and for consistency
call 301–796–7400 for assistance. (Note: with the implementing regulations for the third-
This email address and this telephone I. Background party certification program in 21 CFR parts 1, 11,
and 16, this notice uses the term ‘‘third-party
number are for assistance with Section 307 of FSMA, Accreditation certification body’’ rather than the term ‘‘third-party
establishment registration only; they are of Third-Party Auditors, amended the auditor’’ used in section 808(a)(3) of the FD&C Act.
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![41038 Federal Register / Vol. 82, No. 166 / Tuesday, August 29, 2017 / Notices
fee within 90 days of the due date, we Dated: August 24, 2017. Research; 93.394, Cancer Detection and
will withdraw its accreditation. Anna Snouffer, Diagnosis Research; 93.395, Cancer
Deputy Director, Office of Federal Advisory Treatment Research; 93.396, Cancer Biology
Dated: August 23, 2017. Research; 93.397, Cancer Centers Support;
Committee Policy.
Anna K. Abram, 93.398, Cancer Research Manpower; 93.399,
[FR Doc. 2017–18339 Filed 8–28–17; 8:45 am] Cancer Control, National Institutes of Health,
Deputy Commissioner for Policy, Planning, BILLING CODE 4140–01–P HHS)
Legislation, and Analysis.
[FR Doc. 2017–18222 Filed 8–28–17; 8:45 am] Dated: August 24, 2017.
BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND Melanie J. Pantoja,
HUMAN SERVICES Program Analyst, Office of Federal Advisory
Committee Policy.
DEPARTMENT OF HEALTH AND National Institutes of Health [FR Doc. 2017–18343 Filed 8–28–17; 8:45 am]
HUMAN SERVICES BILLING CODE 4140–01–P
National Cancer Institute; Notice of
National Institutes of Health Meeting
Pursuant to section 10(d) of the DEPARTMENT OF HOMELAND
Office of the Director, National Federal Advisory Committee Act, as SECURITY
Institutes of Health: Notice of Closed amended, notice is hereby given of a
Meeting meeting of the National Cancer Institute Coast Guard
Council of Research Advocates. [Docket No. USCG–2017–0690]
Pursuant to section 10(d) of the The meeting will be open to the
Federal Advisory Committee Act, as public, with attendance limited to space Cooperative Research and
amended, notice is hereby given of a available. Individuals who plan to Development Agreement:
meeting of the Advisory Committee to attend and need special assistance, such Environmentally Friendly Buoy
the Director, National Institutes of as sign language interpretation or other Mooring System
Health. reasonable accommodations, should
notify the Contact Person listed below Coast Guard, DHS.
AGENCY:
The meeting will be closed to the
public in accordance with the in advance of the meeting. The open Notice of intent; request for
ACTION:
provisions set forth in sections session will be videocast and can be comments.
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., accessed from the NIH Videocasting and
SUMMARY: The Coast Guard is
as amended. The grant applications and Podcasting Web site (http://
videocast.nih.gov). announcing its intent to enter into a
the discussions could disclose Cooperative Research and Development
confidential trade secrets or commercial Name of Committee: National Cancer Agreement (CRADA) with American
property such as patentable material, Institute Council of Research Advocates.
Underwater Contractors, Inc. (AUC) to
Date: September 25, 2017.
and personal information concerning Time: 9:00 a.m. to 4:30 p.m. develop, demonstrate, evaluate and
individuals associated with the grant Agenda: Welcome and Chairman’s document the use of environmentally
applications, the disclosure of which Remarks, NCI Updates and Legislative friendly buoy mooring systems (line and
would constitute a clearly unwarranted Update. anchor) attached to a navigational buoy
invasion of personal privacy. Place: National Institutes of Health, 40 to determine the feasibility and
Convent Drive, Building 40, Conference practicality of the Coast Guard using
Name of Committee: Advisory Committee Rooms 1201/1203, Bethesda, MD 20892. both helix (screw) anchors and elastic
to the Director, National Institutes of Health. Contact Person: Amy Williams, NCI Office
mooring lines in environmentally
Date: September 14, 2017. of Advocacy Relations National Cancer
Time: 2:00 p.m. to 3:00 p.m. Institute, NIH, 31 Center Drive, Building 31, sensitive areas. While the Coast Guard
Agenda: To review and evaluate grant Room 10A28, Bethesda, MD 20892, 240–781– is currently considering partnering with
applications. 3406 williaam@mail.nih.gov. AUC, we are soliciting public comment
Place: National Institutes of Health, Any interested person may file written on the possible nature of and
Building 1, One Center Drive, Bethesda, MD
comments with the committee by forwarding participation of other parties in the
the statement to the Contact Person listed on proposed CRADA. In addition, the Coast
20892 (Telephone Conference Call). this notice. The statement should include the
Contact Person: Gretchen Wood, Staff Guard also invites other potential non-
name, address, telephone number and when Federal participants, who have the
Assistant, National Institutes of Health, applicable, the business or professional
Office of the Director, One Center Drive, affiliation of the interested person. interest and capability to bring similar
Building 1, Room 126, Bethesda, MD 20892, In the interest of security, NIH has contributions to this type of research, to
301–496–4272, Woodgs@od.nih.gov. instituted stringent procedures for entrance consider submitting proposals for
(Catalogue of Federal Domestic Assistance onto the NIH campus. All visitor vehicles, consideration in similar CRADAs.
including taxicabs, hotel, and airport shuttles DATES: Comments must be submitted to
Program Nos. 93.14, Intramural Research
will be inspected before being allowed on the online docket via http://
Training Award; 93.22, Clinical Research campus. Visitors will be asked to show one
Loan Repayment Program for Individuals form of identification (for example, a
www.regulations.gov, or reach the
from Disadvantaged Backgrounds; 93.232, government-issued photo ID, driver’s license, Docket Management Facility, on or
Loan Repayment Program for Research or passport) and to state the purpose of their before September 27, 2017.
Generally; 93.39, Academic Research visit. Information is also available on the Synopses of proposals regarding
sradovich on DSK3GMQ082PROD with NOTICES
Enhancement Award; 93.936, NIH Acquired Institute’s/Center’s home page: NCRA: http:// future CRADAs must reach the Coast
Immunodeficiency Syndrome Research Loan deainfo.nci.nih.gov/advisory/ncra/ncra.htm, Guard (see FOR FURTHER INFORMATION
Repayment Program; 93.187, Undergraduate where an agenda and any additional CONTACT) on or before September 27,
Scholarship Program for Individuals from information for the meeting will be posted 2017.
when available.
Disadvantaged Backgrounds, National
(Catalogue of Federal Domestic Assistance ADDRESSES: Submit comments online at
Institutes of Health, HHS)
Program Nos. 93.392, Cancer Construction; http://www.regulations.gov following
93.393, Cancer Cause and Prevention Web site instructions.
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Document Created: 2017-08-29 01:58:12
Document Modified: 2017-08-29 01:58:12
| 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 | This fee is effective October 1, 2017. | |
| Contact | Donald Prater, Office of Foods and Veterinary Medicine, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 3234, Silver Spring, MD 20993, 301-348-3007. | |
| FR Citation | 82 FR 41035 |
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