82 FR 35971 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; De Novo Classification Process (Evaluation of Automatic Class III Designation)
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 147 (August 2, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 147 (August 2, 2017)
| Page Range | 35971-35973 | |
| FR Document | 2017-16230 |
[Federal Register Volume 82, Number 147 (Wednesday, August 2, 2017)] [Notices] [Pages 35971-35973] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-16230] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0689] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; De Novo Classification Process (Evaluation of Automatic Class III Designation) AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of information by September 1, 2017. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, or emailed to [email protected]. All [[Page 35972]] comments should be identified with the OMB control number 0910-NEW and title ``De Novo Classification Process (Evaluation of Automatic Class III Designation).'' Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-8867, [email protected]. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. De Novo Classification Process (Evaluation of Automatic Class III Designation) OMB Control Number 0910--NEW The draft guidance entitled ``De Novo Classification Process (Evaluation of Automatic Class III Designation)'' provides guidance on the process for the submission and review of a De Novo classification request (hereafter a ``De Novo request'') under section 513(f)(2) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360c(f)(2)), also known as the De Novo classification process. This process provides a pathway to class I or class II classification for medical devices for which general controls or general and special controls provide a reasonable assurance of safety and effectiveness, but for which there is no legally marketed predicate device. The proposed collection of information is necessary to satisfy the previously mentioned statutory requirements for implementing this voluntary submission program. In the Federal Register of August 14, 2014 (79 FR 47651), FDA published a 60-day notice requesting public comment on the proposed collection of information. Seven organizations commented on the draft guidance document. None of the comments were related to the information collection. Upon further review of the information collection, it has come to our attention that the 60-day notice did not include an estimated hour burden for requests for withdrawal or estimated operating and maintenance costs for eCopy,\1\ printing, and shipping of De Novo submissions. To correct this oversight, we have included these estimates here. --------------------------------------------------------------------------- \1\ See the eCopy guidance, ``eCopy Program for Medical Device Submissions; Guidance for Industry and Food and Drug Administration Staff,'' at https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-gen/documents/document/ucm313794.pdf. --------------------------------------------------------------------------- FDA estimates the burden of this collection of information as follows: Table 1--Estimated Annual Reporting Burden \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Total Number of Number of Total annual Average burden operating and Activity respondents responses per responses per response Total hours maintenance respondent costs -------------------------------------------------------------------------------------------------------------------------------------------------------- De Novo request under section 513(f)(2)(i) of the FD&C Act -------------------------------------------------------------------------------------------------------------------------------------------------------- CDRH.................................................... 25 1 25 100 2,500 .............. CBER.................................................... 1 1 1 100 100 .............. -------------------------------------------------------------------------------------------------------------------------------------------------------- De Novo request under section 513(f)(2)(ii) of the FD&C Act -------------------------------------------------------------------------------------------------------------------------------------------------------- CDRH.................................................... 25 1 25 180 4,500 .............. CBER.................................................... 1 1 1 180 180 .............. ----------------------------------------------------------------------------------------------- Total De Novo requests.............................. .............. .............. 52 .............. 7,280 $6,308 Request for withdrawal.................................. 5 1 5 10 50 5 ----------------------------------------------------------------------------------------------- Total........................................... .............. .............. .............. .............. 7,330 6,313 -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs associated with this collection of information. FDA estimates from past experience with the De Novo classification program that the complete process involved with the program under section 513(f)(2)(i) of the FD&C Act takes approximately 100 hours, and the complete process under section 513(f)(2)(ii) of the FD&C Act takes approximately 180 hours. This includes the time for any supplements or amendments to the original submission. We estimate that requests for withdrawal take approximately 10 minutes. The average burdens per response are based upon estimates by FDA administrative and technical staff who are familiar with the requirements for submission of a De Novo request (and related materials), have consulted and advised manufacturers on the submissions, and have reviewed the documentation submitted. Respondents to the information collection are medical device manufacturers seeking to market medical device products that have been classified into class III under section 513(f)(2) of the FD&C Act. It is expected that the number of De Novo requests will reach a steady rate of approximately 52 submissions per year. We expect that we will receive approximately five requests for withdrawal per year. The operating and maintenance cost for a De Novo submission includes the cost of printing, shipping, and the eCopy. We estimate the cost burden for a De Novo submission to be $121.30 ($90 printing + $30 shipping + $1.30 eCopy). The annual cost estimate for De Novo submissions is $6,308 (rounded) (52 submissions x $121.30). We estimate the cost for a request for withdrawal to be $1 (rounded) ($0.09 printing 1 page + $0.03 shipping + $1.30 eCopy). The annual cost estimate for requests for withdrawal is $5. The draft guidance also refers to currently approved information collections found in FDA regulations. The collections of information in 21 CFR part 807, subpart E, are approved under OMB control number 0910- 0120. [[Page 35973]] Dated July 27, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-16230 Filed 8-1-17; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 82, No. 147 / Wednesday, August 2, 2017 / Notices 35971
VIII. Procedures for Paying the FY 2018 New York, NY 10045, FDA Deposit able to print a copy of your cover sheet
Fees Account Number: 75060099, U.S. showing your unique PIN.
Department of Treasury routing/transit Step Three—Send the payment for
A. Application Fees and Payment
number: 021030004, SWIFT Number: your application as described in section
Instructions
FRNYUS33, Beneficiary: FDA, 8455 VIII.A.
The appropriate application fee Colesville Rd., 14th Floor, Silver Spring, Step Four—Please submit your
established in the new fee schedule MD 20993–0002. application and a copy of the completed
must be paid for an animal drug To send a check by a courier such as Animal Drug User Fee Cover Sheet to
application or supplement subject to Federal Express, the courier must the following address: Food and Drug
fees under ADUFA III that is submitted deliver the check and printed copy of Administration, Center for Veterinary
on or after October 1, 2017. The the cover sheet to: U.S. Bank, Attn: Medicine, Document Control Unit
payment must be made in U.S. currency Government Lockbox 979033, 1005 (HFV–199), 7500 Standish Pl.,
by one of the following methods: Wire Convention Plaza, St. Louis, MO 63101. Rockville, MD 20855.
transfer, electronically, check, bank (Note: This address is for courier
draft, or U.S. postal money order made delivery only. If you have any questions C. Product, Establishment, and Sponsor
payable to the Food and Drug concerning courier delivery contact U.S. Fees
Administration. The preferred payment Bank at 314–418–4013. This telephone By December 31, 2017, FDA will issue
method is online using electronic check number is only for questions about invoices and payment instructions for
(Automated Clearing House (ACH) also courier delivery.) product, establishment, and sponsor
known as eCheck) or credit card It is important that the fee arrives at fees for FY 2018 using this fee schedule.
(Discover, VISA, MasterCard, American the bank at least a day or two before the Payment will be due by January 31,
Express). Secure electronic payments application arrives at FDA’s CVM. FDA 2018. FDA will issue invoices in
can be submitted using the User Fees records the official application receipt November 2018 for any products,
Payment Portal at https:// date as the later of the following: The establishments, and sponsors subject to
userfees.fda.gov/pay or the Pay.gov date the application was received by fees for FY 2018 that qualify for fees
payment option is available to you after FDA’s CVM, or the date U.S. Bank after the December 2017 billing.
you submit a cover sheet. (Note: only notifies FDA that your payment in the
Dated: July 26, 2017.
full payments are accepted. No partial full amount has been received, or when
payments can be made online.) Once the U.S. Treasury notifies FDA of Leslie Kux,
you search for and find your invoice, receipt of an electronic or wire transfer Associate Commissioner for Policy.
select ‘‘Pay Now’’ to be redirected to payment. U.S. Bank and the U.S. [FR Doc. 2017–16180 Filed 8–1–17; 8:45 am]
Pay.gov. Electronic payment options are Treasury are required to notify FDA BILLING CODE 4164–01–P
based on the balance due. Payment by within 1 working day, using the PIN
credit card is available only for balances described previously.
that are less than $25,000. If the balance The tax identification number of FDA DEPARTMENT OF HEALTH AND
exceeds this amount, only the ACH is 53–0196965. (Note: In no case should HUMAN SERVICES
option is available. Payments must be the payment for the fee be submitted to
made using U.S. bank accounts as well FDA with the application.) Food and Drug Administration
as U.S. credit cards. [Docket No. FDA–2011–D–0689]
When paying by check, bank draft, or B. Application Cover Sheet Procedures
U.S. postal money order, please write Step One—Create a user account and Agency Information Collection
your application’s unique Payment password. Log on to the ADUFA Web Activities; Submission for Office of
Identification Number (PIN), beginning site at http://www.fda.gov/ForIndustry/ Management and Budget Review;
with the letters AD, on the upper right- UserFees/AnimalDrugUser Comment Request; De Novo
hand corner of your completed Animal FeeActADUFA/default.htm and, under Classification Process (Evaluation of
Drug User Fee Cover Sheet. Also write Tools and Resources, click ‘‘The Animal Automatic Class III Designation)
the FDA post office box number (P.O. Drug User Fee Cover Sheet’’ and then
Box 979033) on the enclosed check, select ‘‘Create ADUFA User Fee Cover AGENCY: Food and Drug Administration,
bank draft, or money order. Mail the Sheet.’’ For security reasons, each firm HHS.
payment and a copy of the completed submitting an application will be ACTION: Notice.
Animal Drug User Fee Cover Sheet to: assigned an organization identification
Food and Drug Administration, P.O. number, and each user will also be SUMMARY: The Food and Drug
Box 979033, St. Louis, MO 63197–9000. required to set up a user account and Administration (FDA) is announcing
When paying by wire transfer, the password the first time you use this site. that a proposed collection of
invoice number needs to be included; Online instructions will walk you information has been submitted to the
without the invoice number, the through this process. Office of Management and Budget
payment may not be applied. If the Step Two—Create an Animal Drug (OMB) for review and clearance under
payment amount is not applied, the User Cover Sheet, transmit it to FDA, the Paperwork Reduction Act of 1995.
invoice amount would be referred to and print a copy. After logging into your DATES: Fax written comments on the
collections. The originating financial account with your user name and collection of information by September
institution may charge a wire transfer password, complete the steps required 1, 2017.
to create an Animal Drug User Fee ADDRESSES: To ensure that comments on
sradovich on DSKBCFCHB2PROD with NOTICES
fee. If the financial institution charges a
wire transfer fee, it is required to add Cover Sheet. One cover sheet is needed the information collection are received,
that amount to the payment to ensure for each animal drug application or OMB recommends that written
that the invoice is paid in full. supplement. Once you are satisfied that comments be faxed to the Office of
Use the following account the data on the cover sheet is accurate Information and Regulatory Affairs,
information when sending a payment by and you have finalized the cover sheet, OMB, Attn: FDA Desk Officer, FAX:
wire transfer: U.S. Department of you will be able to transmit it 202–395–7285, or emailed to oira_
Treasury, TREAS NYC, 33 Liberty St., electronically to FDA and you will be submission@omb.eop.gov. All
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![Federal Register / Vol. 82, No. 147 / Wednesday, August 2, 2017 / Notices 35973
Dated July 27, 2017. comments, that information will be of comments to public dockets, see 80
Anna K. Abram, posted on https://www.regulations.gov. FR 56469, September 18, 2015, or access
Deputy Commissioner for Policy, Planning, • If you want to submit a comment the information at: https://www.gpo.gov/
Legislation, and Analysis. with confidential information that you fdsys/pkg/FR-2015-09-18/pdf/2015-
[FR Doc. 2017–16230 Filed 8–1–17; 8:45 am] do not wish to be made available to the 23389.pdf.
BILLING CODE 4164–01–P public, submit the comment as a Docket: For access to the docket to
written/paper submission and in the read background documents or the
manner detailed (see ‘‘Written/Paper electronic and written/paper comments
DEPARTMENT OF HEALTH AND Submissions’’ and ‘‘Instructions’’). received, go to https://
HUMAN SERVICES Written/Paper Submissions www.regulations.gov and insert the
docket number, found in brackets in the
Food and Drug Administration Submit written/paper submissions as heading of this document, into the
follows: ‘‘Search’’ box and follow the prompts
[Docket No. FDA–2013–D–0744] • Mail/Hand delivery/Courier (for and/or go to the Dockets Management
Antibacterial Therapies for Patients written/paper submissions): Dockets Staff, 5630 Fishers Lane, Rm. 1061,
With an Unmet Medical Need for the Management Staff (HFA–305), Food and Rockville, MD 20852.
Treatment of Serious Bacterial Drug Administration, 5630 Fishers Submit written requests for single
Diseases; Guidance for Industry; Lane, Rm. 1061, Rockville, MD 20852. copies of this guidance to the Division
• For written/paper comments
Availability of Drug Information, Center for Drug
submitted to the Dockets Management
Evaluation and Research, Food and
AGENCY: Food and Drug Administration, Staff, FDA will post your comment, as
Drug Administration, 10001 New
HHS. well as any attachments, except for
information submitted, marked and Hampshire Ave., Hillandale Building.,
ACTION: Notice of availability. 4th Floor, Silver Spring, MD 20993–
identified, as confidential, if submitted
SUMMARY: The Food and Drug as detailed in ‘‘Instructions.’’ 0002. Send one self-addressed adhesive
Administration (FDA or Agency) is Instructions: All submissions received label to assist that office in processing
announcing the availability of a must include the Docket No. FDA– your requests. See the SUPPLEMENTARY
guidance for industry entitled 2013–D–0744 for ‘‘Antibacterial INFORMATION section for electronic
‘‘Antibacterial Therapies for Patients Therapies for Patients With an Unmet access to the guidance document.
With an Unmet Medical Need for the Medical Need for the Treatment of FOR FURTHER INFORMATION CONTACT:
Treatment of Serious Bacterial Serious Bacterial Diseases.’’ Received Joseph G. Toerner, Center for Drug
Diseases.’’ The purpose of the guidance comments will be placed in the docket Evaluation and Research, Food and
is to assist sponsors in the development and, except for those submitted as Drug Administration, 10903 New
of new antibacterial drugs to treat ‘‘Confidential Submissions,’’ publicly Hampshire Ave., Bldg. 22, Rm. 6244,
serious bacterial diseases in patients viewable at https://www.regulations.gov Silver Spring, MD 20993–0002, 301–
with an unmet medical need, including or at the Dockets Management Staff 796–1300.
patients who have a serious bacterial between 9 a.m. and 4 p.m., Monday SUPPLEMENTARY INFORMATION:
disease for which effective antibacterial through Friday.
drugs are limited or lacking. This • Confidential Submissions—To I. Background
guidance finalizes the draft guidance of submit a comment with confidential FDA is announcing the availability of
the same name issued July 2, 2013. information that you do not wish to be a guidance for industry entitled
DATES: Submit either electronic or made publicly available, submit your ‘‘Antibacterial Therapies for Patients
written comments on Agency guidances comments only as a written/paper With an Unmet Medical Need for the
at any time. submission. You should submit two Treatment of Serious Bacterial
ADDRESSES: You may submit comments copies total. One copy will include the Diseases.’’ The purpose of this guidance
as follows: information you claim to be confidential is to assist sponsors in the development
with a heading or cover note that states of new antibacterial drugs for the
Electronic Submissions ‘‘THIS DOCUMENT CONTAINS treatment of serious bacterial diseases in
Submit electronic comments in the CONFIDENTIAL INFORMATION.’’ The patients with an unmet medical need,
following way: Agency will review this copy, including including patients who have a serious
• Federal eRulemaking Portal: the claimed confidential information, in bacterial disease for which effective
https://www.regulations.gov. Follow the its consideration of comments. The antibacterial drugs are limited or
instructions for submitting comments. second copy, which will have the lacking.
Comments submitted electronically, claimed confidential information Efforts to develop new antibacterial
including attachments, to https:// redacted/blacked out, will be available drugs have diminished in the past few
www.regulations.gov will be posted to for public viewing and posted on decades. Because bacteria continue to
the docket unchanged. Because your https://www.regulations.gov. Submit develop resistance to available
comment will be made public, you are both copies to the Dockets Management antibacterial drugs, a situation of unmet
solely responsible for ensuring that your Staff. If you do not wish your name and medical need has arisen in which
comment does not include any contact information to be made publicly patients with serious bacterial diseases
confidential information that you or a available, you can provide this have limited or in some cases no
third party may not wish to be posted, information on the cover sheet and not alternative antibacterial drugs available
sradovich on DSKBCFCHB2PROD with NOTICES
such as medical information, your or in the body of your comments and you for treatment. To foster new
anyone else’s Social Security number, or must identify this information as antibacterial drug development that will
confidential business information, such ‘‘confidential.’’ Any information marked have the potential to keep pace with
as a manufacturing process. Please note as ‘‘confidential’’ will not be disclosed continued selective pressures of
that if you include your name, contact except in accordance with 21 CFR 10.20 antibacterial resistance, FDA is
information, or other information that and other applicable disclosure law. For exploring approaches to help streamline
identifies you in the body of your more information about FDA’s posting development programs for new
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Document Created: 2017-08-02 07:09:20
Document Modified: 2017-08-02 07:09:20
| 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 | Fax written comments on the collection of information by September 1, 2017. | |
| Contact | Amber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-8867, [email protected] | |
| FR Citation | 82 FR 35971 |
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