81 FR 49678 - Agency Information Collection Activities; Proposed Collection; Comment Request; Pre-Submission Program for Medical Devices
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 145 (July 28, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 145 (July 28, 2016)
| Page Range | 49678-49680 | |
| FR Document | 2016-17802 |
[Federal Register Volume 81, Number 145 (Thursday, July 28, 2016)] [Notices] [Pages 49678-49680] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-17802] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-0530] Agency Information Collection Activities; Proposed Collection; Comment Request; Pre-Submission Program for Medical Devices 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, including each proposed extension of an existing collection of [[Page 49679]] information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on requests for feedback submitted under the Pre-Submission program for medical devices. DATES: Submit either electronic or written comments on the collection of information by September 26, 2016. ADDRESSES: You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://www.regulations.gov. If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ``Written/Paper Submissions'' and ``Instructions''). Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ``Instructions.'' Instructions: All submissions received must include the Docket No. FDA-2012-D-0530 for ``Agency Information Collection Activities; Proposed Collection; Comment Request; Pre-Submission Program for Medical Devices.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Confidential Submissions--To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ``confidential.'' Any information marked as ``confidential'' will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ``Search'' box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20851, [email protected]. 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 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, including each proposed extension of an existing 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. Pre-Submission Program for Medical Devices--OMB Control Number 0910- 0756--Extension The guidance entitled ``Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff'' describes the Pre-Submission program for medical devices reviewed in the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER). The guidance provides recommendations regarding the information that should be submitted in a Pre-Submission package and procedures that should be followed for meetings between CDRH and CBER staff and industry representatives or application sponsors. In addition to Pre- Submissions, the guidance addresses other feedback mechanisms including Informational Meetings, Study Risk Determinations, Formal Early Collaboration Meetings, and Submission Issue Meetings and the procedures to request feedback using these mechanisms. A Pre-Submission is defined as a formal written request from an applicant for feedback from FDA to be provided in the form of a formal written response [[Page 49680]] or, if the manufacturer chooses, a meeting or teleconference in which the feedback is documented in meeting minutes. A Pre-Submission is appropriate when FDA's feedback on specific questions is necessary to guide product development and/or application preparation. The proposed collections of information are necessary to allow the Agency to receive Pre-Submission packages in order to implement this voluntary submission program. For clarity, we are requesting that the title of the information collection request, OMB control number 0910-0756, be changed to ``Pre- Submission Program for Medical Devices.'' FDA estimates the burden of this collection of information as follows: Table 1--Estimated Annual Reporting Burden \1\ ---------------------------------------------------------------------------------------------------------------- Annual FDA Center Number of frequency per Total annual Hours per Total hours respondents response responses response ---------------------------------------------------------------------------------------------------------------- CDRH............................ 2,465 1 2,465 137 337,705 CBER............................ 79 1 79 137 10,823 ------------------------------------------------------------------------------- Total....................... .............. .............. .............. .............. 348,528 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. Respondents are medical device manufacturers subject to FDA's laws and regulations. FDA's annual estimate of 2,544 submissions is based on experienced trends over the past several years. FDA's administrative and technical staffs, who are familiar with the requirements for current Pre-Submissions, estimate that an average of 137 hours is required to prepare a Pre-Submission. Dated: July 21, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-17802 Filed 7-27-16; 8:45 am] BILLING CODE 4164-01-P
![49678 Federal Register / Vol. 81, No. 145 / Thursday, July 28, 2016 / Notices
end of FY 2016, FDA estimates that 523 TABLE 8—FEE SCHEDULE FOR FY is only for questions about courier
establishments will have been billed for 2017—Continued delivery).
establishment fees, before all decisions Please make sure that the FDA post
on requests for waivers or reductions are Fee rates office box number (P.O. Box 979107) is
made. FDA estimates that a total of 16 Fee category for FY written on the check, bank draft, or
establishment fee waivers or reductions 2017 postal money order.
($) If paying by wire transfer, please
will be made for FY 2016. In addition,
FDA estimates that another 16 full Not requiring clinical data ....... 1,019,050
reference your unique user fee ID
establishment fees will be exempted this Supplements requiring clinical number when completing your transfer.
year based on the orphan drug data ...................................... 1,019,050 The originating financial institution
exemption in section 736(k) of the FD&C Establishments ........................... 512,200 may charge a wire transfer fee. Please
Act. Subtracting 32 establishments (16 Products ...................................... 97,750 ask your financial institution about the
waivers, plus the estimated 16 fee and add it to your payment to ensure
establishments under the orphan VIII. Fee Payment Options and that your fee is fully paid. The account
exemption) from 523 leaves a net of 491 Procedures information for wire transfers is as
fee-paying establishments. FDA will use follows: U.S. Department of the
A. Application Fees Treasury, TREAS NYC, 33 Liberty St.,
491 to estimate the FY 2017
establishments paying fees. The fee per The appropriate application fee New York, NY 10045, Acct. No.:
establishment is determined by dividing established in the new fee schedule 75060099, Routing No.: 021030004,
the adjusted total fee revenue to be must be paid for any application or SWIFT: FRNYUS33, Beneficiary: FDA,
derived from establishments supplement subject to fees under 8455 Colesville Rd., 14th Floor, Silver
($251,508,000) by the estimated 491 PDUFA that is received on or after Spring, MD 20993–0002.
establishments, for an establishment fee October 1, 2016. Payment must be made The tax identification number of FDA
rate for FY 2017 of $512,200 (rounded in U.S. currency by electronic check, is 53–0196965.
to the nearest hundred dollars). check, bank draft, wire transfer, or U.S. B. Establishment and Product Fees
B. Product Fees postal money order payable to the order
of the Food and Drug Administration. FDA will issue invoices for
At the beginning of FY 2016, the The preferred payment method is online establishment and product fees for FY
product fee was based on an estimate using electronic check (Automated 2017 under the new fee schedule in
that 2,480 products would be subject to Clearing House (ACH) also known as August 2016. Payment will be due on
and would pay product fees. By the end eCheck) or credit card (Discover, VISA, October 1, 2016. FDA will issue
of FY 2016, FDA estimates that 2,646 MasterCard, American Express). Secure invoices in November 2017 for any
products will have been billed for electronic payments can be submitted products and establishments subject to
product fees, before all decisions on using the User Fees Payment Portal at fees for FY 2017 that qualify for fee
requests for waivers, reductions, or https://userfees.fda.gov/pay. Once you assessments after the August 2016
exemptions are made. FDA assumes that search for your invoice, click ‘‘Pay billing.
there will be 41 waivers and reductions Now’’ to be redirected to Pay.gov. Note Dated: July 25, 2016.
granted. In addition, FDA estimates that that electronic payment options are Leslie Kux,
another 32 product fees will be based on the balance due. Payment by Associate Commissioner for Policy.
exempted this year based on the orphan credit card is available for balances less
[FR Doc. 2016–17870 Filed 7–27–16; 8:45 am]
drug exemption in section 736(k) of the than $25,000. If the balance exceeds this
FD&C Act. FDA estimates that 2,573 BILLING CODE 4164–01–P
amount, only the ACH option is
products will qualify for and pay
available. Payments must be drawn on
product fees in FY 2016, after allowing
U.S bank accounts as well as U.S. credit DEPARTMENT OF HEALTH AND
for an estimated 73 waivers and
cards. HUMAN SERVICES
reductions, including the orphan drug
products, and will use this number for FDA has partnered with the U.S.
Department of the Treasury to use Food and Drug Administration
its FY 2017 estimate. The FY 2017
product fee rate is determined by Pay.gov, a Web-based payment [Docket No. FDA–2012–D–0530]
dividing the adjusted total fee revenue application, for online electronic
payment. The Pay.gov feature is Agency Information Collection
to be derived from product fees
available on the FDA Web site after the Activities; Proposed Collection;
($251,508,000) by the estimated 2,573
user fee ID number is generated. Comment Request; Pre-Submission
products for a FY 2017 product fee of
Please include the user fee Program for Medical Devices
$97,750 (rounded to the nearest ten
dollars). identification (ID) number on your AGENCY: Food and Drug Administration,
check, bank draft, or postal money HHS.
VII. Fee Schedule for FY 2017 order. Your payment can be mailed to:
ACTION: Notice.
The fee rates for FY 2017 are Food and Drug Administration, P.O.
displayed in table 8: Box 979107, St. Louis, MO 63197–9000. SUMMARY: The Food and Drug
If checks are to be sent by a courier Administration (FDA) is announcing an
TABLE 8—FEE SCHEDULE FOR FY that requests a street address, the opportunity for public comment on the
2017 courier can deliver the checks to: U.S. proposed collection of certain
Bank, Attention: Government Lockbox
Lhorne on DSK30JT082PROD with NOTICES
information by the Agency. Under the
Fee rates 979107, 1005 Convention Plaza, St. Paperwork Reduction Act of 1995 (the
for FY Louis, MO 63101. (Note: This U.S. Bank PRA), Federal Agencies are required to
Fee category 2017 address is for courier delivery only. If
($) publish notice in the Federal Register
you have any questions concerning concerning each proposed collection of
Applications: courier delivery contact the U.S. Bank at information, including each proposed
Requiring clinical data ............. 2,038,100 314–418–4013. This telephone number extension of an existing collection of
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![49680 Federal Register / Vol. 81, No. 145 / Thursday, July 28, 2016 / Notices
or, if the manufacturer chooses, a application preparation. The proposed For clarity, we are requesting that the
meeting or teleconference in which the collections of information are necessary title of the information collection
feedback is documented in meeting to allow the Agency to receive Pre- request, OMB control number 0910–
minutes. A Pre-Submission is Submission packages in order to 0756, be changed to ‘‘Pre-Submission
appropriate when FDA’s feedback on implement this voluntary submission Program for Medical Devices.’’
specific questions is necessary to guide program. FDA estimates the burden of this
product development and/or collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Annual
Number of Total annual Hours per
FDA Center frequency per Total hours
respondents responses response
response
CDRH ................................................................................... 2,465 1 2,465 137 337,705
CBER ................................................................................... 79 1 79 137 10,823
Total .............................................................................. ........................ ........................ ........................ ........................ 348,528
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Respondents are medical device ADDRESSES: FDA White Oak Campus, FDA intends to make background
manufacturers subject to FDA’s laws 10903 New Hampshire Ave., Bldg. 31 material available to the public no later
and regulations. FDA’s annual estimate Conference Center, the Great Room (Rm. than 2 business days before the meeting.
of 2,544 submissions is based on 1503), Silver Spring, MD 20993–0002. If FDA is unable to post the background
experienced trends over the past several Answers to commonly asked questions material on its Web site prior to the
years. FDA’s administrative and including information regarding special meeting, the background material will
technical staffs, who are familiar with accommodations due to a disability, be made publicly available at the
the requirements for current Pre- visitor parking, and transportation may location of the advisory committee
Submissions, estimate that an average of be accessed at: http://www.fda.gov/ meeting, and the background material
137 hours is required to prepare a Pre- AdvisoryCommittees/ will be posted on FDA’s Web site after
Submission. AboutAdvisoryCommittees/ the meeting. Background material is
Dated: July 21, 2016.
ucm408555.htm. available at http://www.fda.gov/
Leslie Kux, FOR FURTHER INFORMATION CONTACT: AdvisoryCommittees/Calendar/
Associate Commissioner for Policy. Kalyani Bhatt, Center for Drug default.htm. Scroll down to the
[FR Doc. 2016–17802 Filed 7–27–16; 8:45 am]
Evaluation and Research, Food and appropriate advisory committee meeting
Drug Administration, 10903 New link.
BILLING CODE 4164–01–P
Hampshire Ave., Bldg. 31, Rm. 2417, Procedure: Interested persons may
Silver Spring, MD 20993–0002, 301–
present data, information, or views,
DEPARTMENT OF HEALTH AND 796–9001, FAX: 301–847–8533, email:
orally or in writing, on issues pending
HUMAN SERVICES PDAC@fda.hhs.gov, or FDA Advisory
before the committees. Written
Committee Information Line, 1–800–
741–8138 (301–443–0572 in the submissions may be made to the contact
Food and Drug Administration person on or before August 30, 2016.
Washington, DC area). A notice in the
Federal Register about last minute Oral presentations from the public will
[Docket No. FDA–2016–N–0001] be scheduled between approximately 1
modifications that impact a previously
announced advisory committee meeting p.m. and 2 p.m. Those individuals
Psychopharmacologic Drugs Advisory interested in making formal oral
Committee and the Drug Safety and cannot always be published quickly
enough to provide timely notice. presentations should notify the contact
Risk Management Advisory person and submit a brief statement of
Committee; Notice of Meeting Therefore, you should always check the
Agency’s Web site at http:// the general nature of the evidence or
AGENCY: Food and Drug Administration, www.fda.gov/AdvisoryCommittees/ arguments they wish to present, the
HHS. default.htm and scroll down to the names and addresses of proposed
ACTION: Notice. appropriate advisory committee meeting participants, and an indication of the
link, or call the advisory committee approximate time requested to make
SUMMARY: The Food and Drug information line to learn about possible their presentation on or before August
Administration (FDA) announces a modifications before coming to the 22, 2016. Time allotted for each
forthcoming public advisory committee meeting. presentation may be limited. If the
meeting of the Psychopharmacologic number of registrants requesting to
SUPPLEMENTARY INFORMATION:
Drugs Advisory Committee and the Drug Agenda: The committees will discuss speak is greater than can be reasonably
Safety and Risk Management Advisory a completed postmarketing-requirement accommodated during the scheduled
Committee. The general function of the randomized, placebo controlled trial of open public hearing session, FDA may
committees is to provide advice and conduct a lottery to determine the
Lhorne on DSK30JT082PROD with NOTICES
the neuropsychiatric effects of
recommendations to the Agency on CHANTIX (varenicline), ZYBAN speakers for the scheduled open public
FDA’s regulatory issues. The meeting (bupropion), and nicotine replacement hearing session. The contact person will
will be open to the public. therapy, along with relevant published notify interested persons regarding their
DATES: The meeting will be held on observational studies to determine request to speak by August 23, 2016.
September 14, 2016, from 8 a.m. to 5 whether the findings support changes to Persons attending FDA’s advisory
p.m. product labeling. committee meetings are advised that the
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Document Created: 2016-07-28 01:47:51
Document Modified: 2016-07-28 01:47:51
| 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 September 26, 2016. | |
| Contact | FDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20851, [email protected] | |
| FR Citation | 81 FR 49678 |
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