80 FR 36822 - Agency Information Collection Activities; Proposed Collection; Comment Request; Electronic User Fee Payment Request Forms
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 123 (June 26, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 123 (June 26, 2015)
| Page Range | 36822-36824 | |
| FR Document | 2015-15711 |
[Federal Register Volume 80, Number 123 (Friday, June 26, 2015)] [Notices] [Pages 36822-36824] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-15711] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-N-1837] Agency Information Collection Activities; Proposed Collection; Comment Request; Electronic User Fee Payment Request Forms AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on Electronic User Fee Payment Request Forms. DATES: Submit either electronic or written comments on the collection of information by August 25, 2015. ADDRESSES: Submit electronic comments on the collection of information to http://www.regulations.gov. Submit written comments on the collection of information to the Division of Dockets Management (HFA- 305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, PRAStaff@fda.hhs.gov. SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. ``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or [[Page 36823]] provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document. With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. Electronic User Fee Payment Request Forms--Form FDA 3913 and Form FDA 3914 (OMB Control Number (0910-NEW) The Government Paperwork Elimination Act (GPEA), Public Law 105- 277, title XVII, was signed into law on October 21, 1998. GPEA requires Federal Agencies to allow individuals or entities that deal with the Agencies the option to submit information or transact business with the Agency electronically, when practicable, and to maintain records electronically, when practicable. Its goal is to encourage agencies to incorporate technologically improved respondent reporting as this process typically lowers the burden on the respondent. GPEA allows FDA to collect information relating to a user fee payment refund request and transfer request. Form FDA 3913, User Fee Payment Refund Request, is designed to provide the minimum necessary information for FDA to review and process a user fee payment refund. The information collected includes the organization, contact, and payment information. The information is used to determine the reason for the refund, the refund amount, and who to contact if there are any questions regarding the refund request. A submission of the User Fee Payment Refund Request form does not guarantee that a refund will be issued. FDA estimates an average of 0.40 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed, and complete and review the collection of information. The estimated hours are based on past FDA experience with the user fee payment refund request. In fiscal year 2014, approximately 1,741 user fee refunds were processed for cover sheets and invoices including 27 for Animal Drug User Fee Act, 5 for Animal Generic Drug User Fee Act, 3 for Biosimilar Drug User Fee Act, 1 for a Center for Tobacco Products Civil Money Penalties, 216 for Export Certificate Program, 79 for Freedom of Information Act requests, 523 for Generic Drug User Fee Amendments, 539 for Medical Device User Fee Amendments, 266 for Mammography inspection fee, 81 for Prescription Drug User Fee Act, and 1 for a Tobacco product fee. Form FDA 3914, User Fee Payment Transfer Request, is designed to provide the minimum necessary information for FDA to review and process a user fee payment transfer request. The information collected includes payment and organization information. The information is used to determine the reason for the transfer, how the transfer should be performed, and who to contact if there are any questions regarding the transfer request. A submission of the User Fee Payment Transfer Request form does not guarantee that a transfer will be performed. FDA estimates an average of 0.25 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed, and complete and review the collection of information. FDA estimated hours are based on past FDA experience with the user fee payment transfer request. In fiscal year 2014, approximately 1,291 user fee payment transfers were processed for cover sheets and invoices including 21 for Animal Drug User Fee Act, 2 for Animal Generic Drug User Fee Act, 544 for Generic Drug User Fee Amendments, 627 for Medical Device User Fee Amendments, and 97 for Prescription Drug User Fee Act. Respondents for the electronic request forms include domestic and foreign firms (including pharmaceutical, medical device, etc.). Specifically, refund request forms target respondents who submitted a duplicate payment or overpayment for a user fee cover sheet or invoice. Respondents may also include firms that withdrew an application or submission. Transfer request forms target respondents who submitted payment for a user fee cover sheet or invoice and need that payment to be re-applied to another cover sheet or invoice (transfer of funds). The electronic user fee payment request forms will streamline the refund and transfer processes, facilitate processing, and improve the tracking of requests. The burden for this collection of information is the same for all customers (small and large organizations). The information being requested or required has been held to the absolute minimum required for the intended use of the data. Customers will be able to request a user fee payment refund and transfer online at http://www.fda.gov/forindustry/userfees/default.htm. This electronic submission is intended to reduce the burden for customers to submit a user fee payment refund and transfer request. FDA estimates the burden of this collection of information as follows: Table 1--Estimated Annual Reporting Burden \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of 21 CFR Section Number of responses per Total annual Average burden per Total hours respondents respondent responses response -------------------------------------------------------------------------------------------------------------------------------------------------------- User Fee Payment Refund Request--Form FDA 3913..................... 1,700 1 1,700 0.40 (24 minutes) 680 User Fee Payment Transfer Request--Form FDA 3914................... 1,700 1 1,700 0.25 (15 minutes) 425 ------------------------------------------------------------------------------------ Total.......................................................... .............. .............. .............. ................... 1,105 -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. [[Page 36824]] Dated: June 23, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-15711 Filed 6-25-15; 8:45 am] BILLING CODE 4164-01-P
![36822 Federal Register / Vol. 80, No. 123 / Friday, June 26, 2015 / Notices
generally encompasses three steps— An alternative approach may be used if Dated: June 22, 2015.
point-of-use processing, thorough such approach satisfies the Leslie Kux,
cleaning, and disinfection or requirements of the applicable statute Associate Commissioner for Policy.
sterilization. The Reprocessing and regulations. [FR Doc. 2015–15719 Filed 6–25–15; 8:45 am]
Guidance makes clear, however, that BILLING CODE 4164–01–P
certain devices may be suitably III. Electronic Access
reprocessed after cleaning alone and Persons interested in obtaining a copy
may not require further disinfection or of the draft guidance may do so by DEPARTMENT OF HEALTH AND
sterilization. It is important to note that downloading an electronic copy from HUMAN SERVICES
the Reprocessing Guidance is intended, the Internet. A search capability for all
among other things, to provide guidance Food and Drug Administration
Center for Devices and Radiological
in crafting and validating reprocessing [Docket No. FDA–2015–N–1837]
Health guidance documents is available
instructions to be included in the
at http://www.fda.gov/MedicalDevices/
labeling of reusable devices generally, Agency Information Collection
DeviceRegulationandGuidance/
and it may not be applicable for Activities; Proposed Collection;
determining whether a UDI direct GuidanceDocuments/default.htm.
Guidance documents are also available Comment Request; Electronic User
marking should be required on a Fee Payment Request Forms
specific device intended to be reused. at http://www.regulations.gov. Persons
For purposes of UDI direct marking unable to download an electronic copy AGENCY: Food and Drug Administration,
requirements, FDA considers a device of ‘‘Unique Device Identification: Direct HHS.
that is intended to be cleaned and either Marking of Devices’’ may send an email ACTION: Notice.
sterilized or disinfected to be intended request to CDRH-Guidance@fda.hhs.gov
to receive an electronic copy of the SUMMARY: The Food and Drug
to be reprocessed. FDA has some
document. Please use the document Administration (FDA) is announcing an
concern about whether cleaning alone,
without subsequent sterilization and/or number 1400031 to identify the opportunity for public comment on the
disinfection, should fit within the guidance you are requesting. proposed collection of certain
definition of ‘‘reprocessing’’ for information by the Agency. Under the
IV. Paperwork Reduction Act of 1995 Paperwork Reduction Act of 1995 (the
purposes of UDI direct marking
requirements. Therefore, FDA is seeking PRA), Federal Agencies are required to
This draft guidance refers to
additional information on this issue. publish notice in the Federal Register
previously approved collections of
FDA is particularly interested in concerning each proposed collection of
information described in FDA
receiving information relating to the information and to allow 60 days for
regulations. These collections of
following questions: public comment in response to the
information are subject to review by the
• FDA is concerned that devices notice. This notice solicits comments on
Office of Management and Budget
intended to be used more than once Electronic User Fee Payment Request
(OMB) under the Paperwork Reduction
tend to be separated from its original Forms.
Act of 1995 (44 U.S.C. 3501–3520). The
label during reprocessing, making collections of information in 21 CFR DATES: Submit either electronic or
accurate identification of devices part 801 have been approved under written comments on the collection of
difficult or impossible. Should the OMB control number 0910–0485; the information by August 25, 2015.
definition of ‘‘reprocessing’’ for collections of information in 21 CFR ADDRESSES: Submit electronic
purposes of UDI direct marking part 807, subpart E, have been approved comments on the collection of
requirements include cleaning alone under OMB control number 0910–0120; information to http://
without subsequent disinfection and/or the collections of information in 21 CFR www.regulations.gov. Submit written
sterilization of the device? part 814, subparts A through E, have comments on the collection of
• What public health benefits would been approved under OMB control information to the Division of Dockets
be served by requiring a UDI direct number 0910–0231; and the collections Management (HFA–305), Food and Drug
marking to be affixed to devices of information in 21 CFR part 830 Administration, 5630 Fishers Lane, Rm.
intended to be reused for which pertaining to GUDID labeler accounts 1061, Rockville, MD 20852. All
reprocessing instructions include and data submissions addressed in this comments should be identified with the
cleaning only and not disinfection and/ draft guidance document have been docket number found in brackets in the
or sterilization? approved under OMB control number heading of this document.
This draft guidance, when finalized,
0910–0720. FOR FURTHER INFORMATION CONTACT: FDA
is intended to assist industry,
PRA Staff, Office of Operations, Food
particularly labelers, as defined under V. Comments and Drug Administration, 8455
21 CFR 801.3, and FDA staff understand
Interested persons may submit either Colesville Rd., COLE–14526, Silver
FDA’s requirements for UDI direct
electronic comments regarding this Spring, MD 20993–0002, PRAStaff@
marking of devices, and the criteria for
document to http://www.regulations.gov fda.hhs.gov.
exceptions.
or written comments to the Division of SUPPLEMENTARY INFORMATION: Under the
II. Significance of Guidance Dockets Management (see ADDRESSES). It PRA (44 U.S.C. 3501–3520), Federal
This draft guidance is being issued is only necessary to send one set of Agencies must obtain approval from the
consistent with FDA’s good guidance comments. Identify comments with the Office of Management and Budget
tkelley on DSK3SPTVN1PROD with NOTICES
practices regulation (21 CFR 10.115). docket number found in brackets in the (OMB) for each collection of
The draft guidance represents the heading of this document. Received information they conduct or sponsor.
Agency’s current thinking on ‘‘Unique comments may be seen in the Division ‘‘Collection of information’’ is defined
Device Identification: Direct Marking of of Dockets Management between 9 a.m. in 44 U.S.C. 3502(3) and 5 CFR
Devices.’’ It does not create or confer and 4 p.m., Monday through Friday, and 1320.3(c) and includes Agency requests
any rights for or on any person and does will be posted to the docket at http:// or requirements that members of the
not operate to bind FDA or the public. www.regulations.gov. public submit reports, keep records, or
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![36824 Federal Register / Vol. 80, No. 123 / Friday, June 26, 2015 / Notices
Dated: June 23, 2015. Emergency Shortages Data Collection in the context of a Federally declared
Leslie Kux, System—(OMB Control Number 0910– disaster/emergency, an official
Associate Commissioner for Policy. 0491)—Extension emergency preparedness exercise, or a
[FR Doc. 2015–15711 Filed 6–25–15; 8:45 am] Under section 903(d)(2) of the Federal potential public health risk posed by
BILLING CODE 4164–01–P Food, Drug, and Cosmetic Act (21 U.S.C. non-disaster-related device shortage.
393(d)(2)), the Commissioner of Food The data procurement process
and Drugs is authorized to implement consists of an initial scripted telephone
DEPARTMENT OF HEALTH AND general powers (including conducting call to a regulatory officer at a registered
HUMAN SERVICES research) to carry out effectively the manufacturer of one or more key
mission of FDA. Subsequent to the medical devices tracked in the ESDCS.
Food and Drug Administration events of September 11, 2001, and as In this initial call, the EST member
[Docket No. FDA–2012–N–0197] part of broader counterterrorism and describes the intent and goals of the
emergency preparedness activities, data collection effort and makes the
Agency Information Collection FDA’s Center for Devices and specific data request. After the initial
Activities; Submission for Office of Radiological Health (CDRH) began call, one or more additional follow-up
Management and Budget Review; developing operational plans and calls and/or electronic mail
Comment Request; Emergency interventions that would enable CDRH correspondence may be required to
Shortages Data Collection System to anticipate and respond to medical verify/validate data sent from the
device shortages that might arise in the manufacturer, confirm receipt, and/or
AGENCY: Food and Drug Administration, context of Federally declared disasters/
HHS. request additional detail. Although the
emergencies or regulatory actions. In regulatory officer is the agent who the
ACTION: Notice. particular, CDRH identified the need to EST member initially contacts,
SUMMARY: The Food and Drug acquire and maintain detailed data on regulatory officers may designate an
Administration (FDA) is announcing domestic inventory, manufacturing alternate representative within their
that a proposed collection of capabilities, distribution plans, and raw organization to correspond subsequently
information has been submitted to the material constraints for medical devices with the CDRH EST member who is
Office of Management and Budget that would be in high demand, and/or collecting or verifying/validating the
would be vulnerable to shortages in data.
(OMB) for review and clearance under
specific disaster/emergency situations
the Paperwork Reduction Act of 1995. Because of the dynamic nature of the
or following specific regulatory actions.
DATES: Fax written comments on the Such data could support prospective medical device industry, particularly
collection of information by July 27, risk assessment, help inform risk with respect to specific product lines,
2015. mitigation strategies, and support real- manufacturing capabilities, and raw
ADDRESSES: To ensure that comments on time decision-making by the material/subcomponent sourcing, it is
the information collection are received, Department of Health and Human necessary to update the data in the
OMB recommends that written Services during actual emergencies or ESDCS at regular intervals. The EST
comments be faxed to the Office of emergency preparedness exercises. makes such updates on a regular basis,
Information and Regulatory Affairs, FDA developed ‘‘The Emergency but makes efforts to limit the frequency
OMB, Attn: FDA Desk Officer, FAX: Medical Device Shortages Program of outreach to a specific manufacturer to
202–395–7285, or emailed to oira_ Survey’’ in 2002 to support the no more than every 4 months.
submission@omb.eop.gov. All acquisition of such data from medical The ESDCS will only include those
comments should be identified with the device manufacturers. In 2004, CDRH medical devices for which there will
OMB control number 0910–0491. Also changed the process for the data likely be high demand during a specific
include the FDA docket number found collection, and the electronic database emergency/disaster, or for which there
in brackets in the heading of this in which the data were stored was are sufficiently small numbers of
document. formally renamed the ‘‘Emergency manufacturers such that disruption of
Shortages Data Collection System’’ manufacture or loss of one or more of
FOR FURTHER INFORMATION CONTACT: FDA (ESDCS). Recognizing that some of the
PRA Staff, Office of Operations, Food these manufacturers would create a
data collected may be commercially shortage.
and Drug Administration, 8455 confidential, access to the ESDCS is
Colesville Rd., COLE–14526, Silver restricted to members of the CDRH In the Federal Register of March 18,
Spring, MD 20993–0002, PRAStaff@ Emergency Shortage Team (EST) and 2015 (80 FR 14138), FDA published a
fda.hhs.gov. senior management with a need-to- 60-day notice requesting public
SUPPLEMENTARY INFORMATION: In know. At this time, the need-to-know comment on the proposed collection of
compliance with 44 U.S.C. 3507, FDA senior management personnel are information. No comments were
has submitted the following proposed limited to two senior managers. Further, received.
collection of information to OMB for the data are used by this defined group FDA estimates the burden of this
review and clearance. only for decision making and planning collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
Number of Total annual Average burden
tkelley on DSK3SPTVN1PROD with NOTICES
Activity/FD&C act section responses per Total hours
respondents responses per response
respondent
Emergency Shortages Data Col-
lection System (903(d)(2)) ........ 125 3 375 0.5 (30 minutes) 188
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
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Document Created: 2015-12-15 14:15:29
Document Modified: 2015-12-15 14:15:29
| 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 | Submit either electronic or written comments on the collection of information by August 25, 2015. | |
| Contact | FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected] | |
| FR Citation | 80 FR 36822 |
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