OMB # 2060 0170 Expiration Date: 8/ 31/ 05 U. S. Environmental Protection Agency STRATOSPHERIC OZONE PROTECTION PROGRAM CLASS I CONTROLLED SUBSTANCE REPORT: EXPORTER ANNUAL REPORT ( Sec 82.13( h) AND Sec 82.13( f)( 3)( vi and ix))

SECTION 1 EXPORTING COMPANY IDENTIFICATION 1.1 Date of Submission 1.2 Number of Transactions Reported 1.3 Number of Pages Submitted 1.4 Year to Which This Report Applies: Year 1.5 Exporting Company Information Company Name Street Address City State Zip Code 1.6 Company Contact Identification Reporting Company Contact Person Phone Number Fax Number 1.7 Signature of Reporting Company Representative I certify under penalty of law that I have personally examined and am familiar with the information submitted in this and all attached documents, and that based on my inquiry of those individuals immediately responsible for obtaining the information, I believe that the submitted information is true, accurate, and complete. I am aware that there are significant penalties for submitting false information, including the possibility of fine and imprisonment.

Name Title Signature Date SEND COMPLETED FORMS TO: Tracking System Program Manager Global Programs Division U. S. EPA ( 6205J) 1200 Pennsylvania Avenue, NW Washington, DC 20460 Information in reports submitted in compliance with the final rule may be claimed as confidential. A company may assert a claim of confidentiality for information submitted by clearly marking that information as confidential. Such information shall be treated in accordance with EPA's procedures for information claimed as confidential at 40 CFR Part 2, Subpart B, and will only be disclosed by the means set forth in the subpart. If no claim of confidentiality accompanies the report when it is received by EPA, it may be made public without further notice to the company ( 40 CFR 2.203).

Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information. Public reporting burden for this collection of information is estimated to average 16 hours per response. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations are listed in 40 CFR Part 9 and 48 CFR Chapter 15. Send comments on the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden, including through the use of automated collection techniques to the Director, OPPE Regulatory Information Division, U. S. Environmental Protection Agency ( 2137), 1200 Pennsylvania Avenue, NW, Washington, D. C. 20460; and to the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17th Street, NW, Washington, DC 20503, Attention: Desk Officer for EPA. Include the EPA ICR number and OMB control number in any correspondence. DO NOT SEND THIS FORM TO THE ABOVE ADDRESS. ONLY SEND COMMENTS TO THESE ADDRESSES.

ICR NUMBER 1432.22 E 1, Revised 5/ 05 OMB # 2060 0170 Expiration Date: 8/ 31/ 05 U. S. Environmental Protection Agency STRATOSPHERIC OZONE PROTECTION PROGRAM CLASS I CONTROLLED SUBSTANCE REPORT: EXPORTER ANNUAL REPORT ( Sec 82.13( h) AND SEC 82.13( f)( 3)( vi and ix))

SECTION 2 TRANSACTION RECORDS ( Reproduce additional sheets as needed) 2.1 Company Name 2.2 Transaction Summaries TRANSACTION #

Recipient Company Name Street Address City Country Postal Code Article 5 Country Company Contact Person Phone Number Fax Number Commodity Code of Shipment Quantity of Commodity Exported ( kg)

Class I Substance Exported Quantity of Class I Substance Exported ( kg)

Date of Export ( mm/ dd/ yy) Port of Export from the U. S. Exporter EIN Number from Customs Form 7525 Transformation Destruction Article 5 TRANSACTION #

Recipient Company Name Street Address City Country Postal Code Article 5 Country Company Contact Person Phone Number Fax Number Commodity Code of Shipment Quantity of Commodity Exported ( kg)

Class I Substance Exported Quantity of Class I Substance Exported ( kg)

Date of Export ( mm/ dd/ yy) Port of Export from the U. S. Exporter EIN Number from Customs Form 7525 Transformation Destruction Article 5 TRANSACTION #

Recipient Company Name Street Address City Country Postal Code Article 5 Country Company Contact Person Phone Number Fax Number Commodity Code of Shipment Quantity of Commodity Exported ( kg)

Class I Substance Exported Quantity of Class I Substance Exported ( kg)

Date of Export ( mm/ dd/ yy) Port of Export from the U. S. Exporter EIN Number from Customs Form 7525 Transformation Destruction Article 5 ICR NUMBER 1432.22 E 2, Revised 5/ 05 OMB # 2060 0170 Expiration Date: 8/ 31/ 05 U. S. Environmental Protection Agency STRATOSPHERIC OZONE PROTECTION PROGRAM CLASS I CONTROLLED SUBSTANCE REPORT: EXPORTER ANNUAL REPORT ( Sec 82.13( h) AND SEC 82.13( f)( 3)( vi and ix))

SECTION 3 COMPANY EXPORT TOTALS ( Reproduce Additional Sheets as Needed)

3.1 Company Name 3.2 Transaction Summaries Class I Substance ( Select only one below)

CFC 11 CFC 12 CFC 13 CFC 111 CFC 112 CFC 113 CFC 114 CFC 115 Other CFC ( please specify)

HBFC ( please specify) Halon ( please specify)

Carbon Tetrachloride Methyl Chloroform CBM Country Exported To Quantity of Class I Substance Exported ( kg)

ICR NUMBER 1432.22 E 3, Revised 5/ 05


[Federal Register Volume 85, Number 151 (Wednesday, August 5, 2020)]
[Notices]
[Page 47389]
[FR Doc No: 2020-17039]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-1339]

Pilot Program for Request for Designation and Pre-Request for
Designation Electronic Submissions

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Office of Combination Products (OCP) in the Food and Drug
Administration (FDA) is soliciting applications from members of the
public interested in participating in a voluntary pilot program to help
OCP evaluate a potential new electronic submissions process for
Requests for Designation (RFD) and Pre-RFD. This RFD and Pre-RFD
electronic submission process is intended to improve efficiency and
completeness of RFD and Pre-RFD submissions. OCP plans to accept up to
nine participants for the pilot program. The pilot program is intended
to provide OCP input to inform this evaluation.

DATES: Interested parties should submit an electronic application to
participate in this pilot program by August 19, 2020. We plan to
conduct pilot testing beginning on or about August 26, 2020. See
section III of this document for information on applying for
participation.

FOR FURTHER INFORMATION CONTACT: Danita Dixon, Office of Combination
Products, Food and Drug Administration, 10903 New Hampshire Ave.,
Silver Spring, MD 20993-0002,<PHONE_NUMBER><EMAIL_ADDRESS>
ADDRESSES: If you are interested in participating in this pilot
program, please submit an electronic application to
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    Since its establishment on December 24, 2002, OCP has served as a
resource for sponsors at various stages of development of their
products. Sponsors often seek OCP feedback on whether their medical
product will be regulated as a drug, a device, a biological product, or
a combination product, and which medical product FDA Center (Center for
Devices and Radiological Health, Center for Drug Evaluation and
Research, or Center for Biologics Evaluation and Research) will
regulate it if it is a non-combination product, or will have the
primary jurisdiction for the premarket review and regulation of the
product if it is a combination product.
    There are two ways that a sponsor can receive such feedback from
OCP. One option is to submit an RFD to receive a formal, binding
determination for the sponsor's product with respect to classification
and/or center assignment. The RFD process is codified in 21 CFR part 3,
and OCP has issued a guidance about this process (see ``How to Write a
Request for Designation (RFD)'' at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/how-write-request-designation-rfd). A second option referred to as the Pre-RFD submission
process, is for a sponsor to submit an inquiry to OCP to receive a
preliminary assessment of their product's classification and/or
assignment, which is not binding. The Pre-RFD process allows for more
flexible interaction between sponsors and FDA. RFD and Pre-RFD
submissions to OCP are currently, typically submitted via email,
although some are submitted in paper copies. Regardless of format, some
submissions lack sufficient data for review. Consequently, OCP is
announcing a pilot program to test the functionality of a more
structured RFD and Pre-RFD electronic submission process that should
enhance efficiency and ensure sponsors' understanding of required and
recommended submission content.

II. Pilot Program Participation

    The pilot program to evaluate the RFD and Pre-RFD electronic
submission processes is to last approximately 2 weeks. During the pilot
program, OCP staff will be available to address questions or concerns
that may arise. Pilot program participants will receive training and
will be asked to submit simulated regulatory submissions using data
provided to them by OCP for testing purposes. Pilot program
participants will also be asked to provide written and verbal feedback
during their training and after they submit the simulated regulatory
submissions. This feedback will assist OCP in developing the electronic
submission processes. OCP estimates that each individual participant's
involvement may require about 15 hours over the 2-week period. OCP is
soliciting applications from members of the public, such as combination
product and other medical product sponsors, as well as entities that
may act as authorized agents submitting RFDs or Pre-RFDs for sponsors.
At its discretion, OCP may withdraw a participant from the pilot
program for not completing the requested activities within requested
timeframes.

III. Applications for Participation

    Send applications to participate in the pilot program to
<EMAIL_ADDRESS>Applications should include the following
information: Company and contact name, contact phone number, and
contact email address. Additionally, although not required for
consideration, OCP is particularly interested in whether you are a
sponsor or may act as an authorized agent, and whether you have
previously submitted an RFD or Pre-RFD. Once applications for
participation are received, FDA will contact interested applicants to
confirm selection for the pilot program. FDA is seeking a limited
number of participants (no more than nine) to participate in this pilot
program.

    Dated: July 30, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-17039 Filed 8-4-20; 8:45 am]
BILLING CODE 4164-01-P