83 FR 22495 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 94 (May 15, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 94 (May 15, 2018)
| Page Range | 22495-22496 | |
| FR Document | 2018-10281 |
[Federal Register Volume 83, Number 94 (Tuesday, May 15, 2018)] [Notices] [Pages 22495-22496] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-10281] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA-2017-N-4951; FDA-2017-N-5569; FDA-2017-N-6145; FDA- 2011-N-0275; FDA-2017-N-7012; and FDA-2017-N-6175] Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is publishing a list of information collections that have been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726, [email protected]. SUPPLEMENTARY INFORMATION: The following is a list of FDA information collections recently approved by OMB under section 3507 of the Paperwork Reduction Act of 1995 (44 U.S.C. 3507). The OMB control number and expiration date of OMB approval for each information collection are shown in table 1. Copies of the supporting statements for the information collections are available on the internet at https://www.reginfo.gov/public/do/PRAMain. 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. Table 1--List of Information Collections Approved By OMB ------------------------------------------------------------------------ OMB control Date approval Title of collection number expires ------------------------------------------------------------------------ Medical Devices; Humanitarian Use 0910-0332 3/31/2021 Devices................................ Medical Devices; Device Tracking........ 0910-0442 3/31/2021 Dispute Resolution Procedures for 0910-0566 3/31/2021 Science-Based Decisions on Products Regulated by the Center for Veterinary Medicine............................... Certification to Accompany Drug, 0910-0616 3/31/2021 Biological Product, and Device Applications or Submissions (Form FDA 3674).................................. Use of Public Human Genetic Variant 0910-0850 3/31/2021 Databases to Support Clinical Validity for Genetic and Genomic-Based In Vitro Diagnostics............................ [[Page 22496]] Food and Drug Administration Recall 0910-0249 4/30/2021 Regulations............................ ------------------------------------------------------------------------ Dated: May 9, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-10281 Filed 5-14-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 94 / Tuesday, May 15, 2018 / Notices 22495
based on past FDA experience with user refund request forms target respondents of information is the same for all
fee payment transfer requests. who submitted a duplicate payment or customers (small and large
In fiscal year 2017, approximately 871 overpayment for a user fee cover sheet organizations). The information being
user fee payment transfers were or invoice. Respondents may also requested or required has been held to
processed for cover sheets and invoices include firms that withdrew an the absolute minimum required for the
including 8 for Animal Drug User Fee application or submission. Transfer intended use of the data. Customers will
Act, 1 for Animal Generic Drug User Fee request forms target respondents who be able to request a user fee payment
Act, 1 for Biosimilar Drug User Fee Act, submitted payment for a user fee cover refund and transfer online at https://
163 for Generic Drug User Fee sheet or invoice and need that payment www.fda.gov/forindustry/userfees/
Amendments, 692 for Medical Device to be reapplied to another cover sheet or
default.htm. This electronic submission
User Fee Amendments, and 6 for invoice (transfer of funds).
The electronic user fee payment is intended to reduce the burden for
Prescription Drug User Fee Act.
Respondents for the electronic request request forms will streamline the refund customers to submit user fee payment
forms include domestic and foreign and transfer processes, facilitate refund and transfer requests.
firms (including pharmaceutical, processing, and improve the tracking of FDA estimates the burden of this
medical device, etc.). Specifically, requests. The burden for this collection collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
Number of Total annual Average burden
21 CFR section responses per Total hours
respondents responses per response
respondent
User Fee Payment Refund Request—Form FDA 1,657 1 1,657 0.40 (24 minutes) ......... 663
3913.
User Fee Payment Transfer Request—Form 871 1 871 0.25 (15 minutes) ......... 218
FDA 3914.
Total ............................................................... ........................ ........................ ........................ ....................................... 881
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
We have adjusted our burden DEPARTMENT OF HEALTH AND and Drug Administration, Three White
estimate, which has resulted in a HUMAN SERVICES Flint North, 10A–12M, 11601
decrease to the currently approved Landsdown St., North Bethesda, MD
burden. New information technology Food and Drug Administration 20852, 301–796–7726, PRAStaff@
applications have more accurately [Docket Nos. FDA–2017–N–4951; FDA– fda.hhs.gov.
calculated the number of registrants of 2017–N–5569; FDA–2017–N–6145; FDA–
drug facilities/food facilities/medical 2011–N–0275; FDA–2017–N–7012; and SUPPLEMENTARY INFORMATION: The
device facilities/medicated feed FDA–2017–N–6175] following is a list of FDA information
facilities, and we have therefore revised collections recently approved by OMB
Agency Information Collection under section 3507 of the Paperwork
the number of respondents to the Activities; Announcement of Office of
information collection. Reduction Act of 1995 (44 U.S.C. 3507).
Management and Budget Approvals The OMB control number and
Dated: May 10, 2018. expiration date of OMB approval for
AGENCY: Food and Drug Administration,
Leslie Kux, HHS. each information collection are shown
Associate Commissioner for Policy. ACTION: Notice. in table 1. Copies of the supporting
[FR Doc. 2018–10329 Filed 5–14–18; 8:45 am] statements for the information
SUMMARY: The Food and Drug collections are available on the internet
BILLING CODE 4164–01–P
Administration (FDA) is publishing a at https://www.reginfo.gov/public/do/
list of information collections that have PRAMain. An Agency may not conduct
been approved by the Office of or sponsor, and a person is not required
Management and Budget (OMB) under
to respond to, a collection of
the Paperwork Reduction Act of 1995.
information unless it displays a
FOR FURTHER INFORMATION CONTACT: Ila
currently valid OMB control number.
S. Mizrachi, Office of Operations, Food
TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB
OMB control Date approval
Title of collection number expires
Medical Devices; Humanitarian Use Devices ......................................................................................................... 0910–0332 3/31/2021
daltland on DSKBBV9HB2PROD with NOTICES
Medical Devices; Device Tracking .......................................................................................................................... 0910–0442 3/31/2021
Dispute Resolution Procedures for Science-Based Decisions on Products Regulated by the Center for Veteri-
nary Medicine ....................................................................................................................................................... 0910–0566 3/31/2021
Certification to Accompany Drug, Biological Product, and Device Applications or Submissions (Form FDA
3674) .................................................................................................................................................................... 0910–0616 3/31/2021
Use of Public Human Genetic Variant Databases to Support Clinical Validity for Genetic and Genomic-Based
In Vitro Diagnostics .............................................................................................................................................. 0910–0850 3/31/2021
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![22496 Federal Register / Vol. 83, No. 94 / Tuesday, May 15, 2018 / Notices
TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB—Continued
OMB control Date approval
Title of collection number expires
Food and Drug Administration Recall Regulations ................................................................................................. 0910–0249 4/30/2021
Dated: May 9, 2018. The https://www.regulations.gov well as any attachments, except for
Leslie Kux, electronic filing system will accept information submitted, marked and
Associate Commissioner for Policy. comments until midnight Eastern Time identified, as confidential, if submitted
[FR Doc. 2018–10281 Filed 5–14–18; 8:45 am] at the end of June 19, 2018. Comments as detailed in ‘‘Instructions.’’
BILLING CODE 4164–01–P
received by mail/hand delivery/courier Instructions: All submissions received
(for written/paper submissions) will be must include the Docket No. FDA–
considered timely if they are 2018–N–1577 for ‘‘Pediatric Oncology
DEPARTMENT OF HEALTH AND postmarked or the delivery service Subcommittee of the Oncologic Drugs
HUMAN SERVICES acceptance receipt is on or before that Advisory Committee; Notice of Meeting;
date. Establishment of a Public Docket;
Food and Drug Administration Comments received on or before June Request for Comments.’’ Received
5, 2018, will be provided to the comments, those filed in a timely
[Docket No. FDA–2018–N–1577] manner (see ADDRESSES), will be placed
committee. Comments received after
that date will be taken into in the docket and, except for those
Pediatric Oncology Subcommittee of
consideration by FDA. submitted as ‘‘Confidential
the Oncologic Drugs Advisory
You may submit comments as Submissions,’’ publicly viewable at
Committee; Notice of Meeting;
follows: https://www.regulations.gov or at the
Establishment of a Public Docket;
Dockets Management Staff between 9
Request for Comments Electronic Submissions a.m. and 4 p.m., Monday through
AGENCY: Food and Drug Administration, Submit electronic comments in the Friday.
HHS. following way: • Confidential Submissions—To
ACTION: Notice; establishment of a • Federal eRulemaking Portal: submit a comment with confidential
public docket; request for comments. https://www.regulations.gov. Follow the information that you do not wish to be
instructions for submitting comments. made publicly available, submit your
SUMMARY: The Food and Drug Comments submitted electronically, comments only as a written/paper
Administration (FDA) announces a including attachments, to https:// submission. You should submit two
forthcoming public advisory committee www.regulations.gov will be posted to copies total. One copy will include the
meeting of the Pediatric Oncology the docket unchanged. Because your information you claim to be confidential
Subcommittee of the Oncologic Drugs comment will be made public, you are with a heading or cover note that states
Advisory Committee. The general solely responsible for ensuring that your ‘‘THIS DOCUMENT CONTAINS
function of the committee is to provide comment does not include any CONFIDENTIAL INFORMATION.’’ FDA
advice and recommendations to FDA on confidential information that you or a will review this copy, including the
regulatory issues. The meeting will be third party may not wish to be posted, claimed confidential information, in its
open to the public. FDA is establishing such as medical information, your or consideration of comments. The second
a docket for public comment on this anyone else’s Social Security number, or copy, which will have the claimed
document. confidential business information, such confidential information redacted/
as a manufacturing process. Please note blacked out, will be available for public
DATES: The meeting will be held on June viewing and posted on https://
that if you include your name, contact
20, 2018, from 8 a.m. to 4:30 p.m. www.regulations.gov. Submit both
information, or other information that
ADDRESSES: FDA White Oak Campus, identifies you in the body of your copies to the Dockets Management Staff.
10903 New Hampshire Ave., Bldg. 31 comments, that information will be If you do not wish your name and
Conference Center, the Great Room (Rm. posted on https://www.regulations.gov. contact information be made publicly
1503), Silver Spring, MD 20993–0002. • If you want to submit a comment available, you can provide this
Answers to commonly asked questions with confidential information that you information on the cover sheet and not
including information regarding special do not wish to be made available to the in the body of your comments and you
accommodations due to a disability, public, submit the comment as a must identify the information as
visitor parking, and transportation may written/paper submission and in the ‘‘confidential.’’ Any information marked
be accessed at: https://www.fda.gov/ manner detailed (see ‘‘Written/Paper as ‘‘confidential’’ will not be disclosed
AdvisoryCommittees/ Submissions’’ and ‘‘Instructions’’). except in accordance with 21 CFR 10.20
AboutAdvisoryCommittees/ and other applicable disclosure law. For
ucm408555.htm. Written/Paper Submissions more information about FDA’s posting
FDA is establishing a docket for Submit written/paper submissions as of comments to public dockets, see 80
public comment on this meeting. The follows: FR 56469, September 18, 2015, or access
docket number is FDA–2018–N–1577. • Mail/Hand delivery/Courier (for the information at: https://www.gpo.gov/
daltland on DSKBBV9HB2PROD with NOTICES
The docket will close on June 19, 2018. written/paper submissions): Dockets fdsys/pkg/FR-2015-09-18/pdf/2015-
Submit either electronic or written Management Staff (HFA–305), Food and 23389.pdf.
comments on this public meeting by Drug Administration, 5630 Fishers Docket: For access to the docket to
June 19, 2018. Please note that late, Lane, Rm. 1061, Rockville, MD 20852. read background documents or the
untimely filed comments will not be • For written/paper comments electronic and written/paper comments
considered. Electronic comments must submitted to the Dockets Management received, go to https://
be submitted on or before June 19, 2018. Staff, FDA will post your comment, as www.regulations.gov and insert the
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Document Created: 2018-05-15 00:33:17
Document Modified: 2018-05-15 00:33:17
| 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. | |
| Contact | Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726, [email protected] | |
| FR Citation | 83 FR 22495 |
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