83 FR 61385 - Prescription Drug User Fee Act of 2017; Electronic Submissions and Data Standards; Announcement of Public Meeting; Request for Comments
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 230 (November 29, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 230 (November 29, 2018)
| Page Range | 61385-61387 | |
| FR Document | 2018-25958 |
[Federal Register Volume 83, Number 230 (Thursday, November 29, 2018)] [Notices] [Pages 61385-61387] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-25958] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-N-4337] Prescription Drug User Fee Act of 2017; Electronic Submissions and Data Standards; Announcement of Public Meeting; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public meeting; request for comments. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the following public meeting entitled ``Prescription Drug User Fee Act of 2017; Electronic Submissions and Data Standards.'' FDA is also requesting public comments on the subject. The purpose of the meeting and the request for comments is to fulfill FDA's commitment to seek stakeholder input related to data standards and the electronic submission system's past performance, future targets, emerging industry needs, and technology initiatives. FDA will use the information from the public meeting as well as from comments submitted to the docket to provide input into data standards initiatives, the FDA Information Technology (IT) Strategic Plan, and electronic submissions gateway target timeframes. DATES: The public meeting will be held on April 10, 2019, from 9 a.m. to 4 p.m. Submit either electronic or written comments by April 10, 2019. See the SUPPLEMENTARY INFORMATION section for registration date and information. [[Page 61386]] ADDRESSES: The public meeting will be held at the FDA White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (Rm. 1503, Section A), Silver Spring, MD 20993-0002. Entrance for public meeting participants (non-FDA employees) is through Building 1, where routine security check procedures will be performed. For parking and security information, please refer to https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm. You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before April 10, 2019. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of April 10, 2019. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://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 https://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): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Dockets Management Staff, 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-2018-N-4337 for ``Prescription Drug User Fee Act of 2017; Electronic Submissions and Data Standards.'' Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff 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 https://www.regulations.gov. Submit both copies to the Dockets Management Staff. 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 laws. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Chenoa Conley, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 1117, Silver Spring, MD 20993-0002, 301- 796-0035, [email protected], or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911. SUPPLEMENTARY INFORMATION: I. Background FDA is committed to achieve the long-term goal of improving the predictability and consistency of the electronic submission process and enhancing transparency and accountability of FDA information technology-related activities. In the PDUFA VI commitment letter, FDA agreed to hold annual public meetings to seek stakeholder input related to electronic submissions and data standards to inform the FDA IT Strategic Plan and published targets. The commitment letter outlines FDA's performance goals and procedures under the PDUFA program for the years 2018 through 2022. The commitment letter can be found at https://www.fda.gov/forindustry/userfees/prescriptiondruguserfee/ucm446608.htm. FDA will consider all comments made at this meeting or received through the docket (see ADDRESSES). II. Participating in the Public Meeting Registration: To register to attend ``Prescription Drug User Fee Act of 2017; Electronic Submissions and Data Standards,'' please register at https://www.eventbrite.com/e/pdufa-vi-public-meeting-on-electronic-submissions-and-data-standards-tickets-49895060469. Please provide complete contact information for each attendee, including name, title, affiliation, address, email, and telephone. A draft agenda will be posted approximately 1 month prior to the meeting. Registration is free and based on space availability, with priority given to early registrants. Persons interested in attending this public meeting on April 10, 2019, must register by 11:59 p.m. on March 22, 2019, Eastern Time. Early registration is recommended because seating is limited; therefore, FDA may limit the number of participants from each organization. Registrants will receive confirmation when they have been accepted. Request for Oral Presentations: During online registration, you may indicate if you wish to present during the public [[Page 61387]] comment session and which topic(s) you would like to address. FDA will do its best to accommodate requests to make public comments. Individuals and organizations with common interests are urged to consolidate or coordinate their presentations. Following the close of registration, FDA will determine the amount of time allotted to each presenter and the approximate time each oral presentation is to begin and will select and notify participants by March 27, 2019. All requests to make oral presentations must be received by the close of registration at 11:59 on March 22, 2019, Eastern Time. If selected for presentation, any presentation materials must be emailed to [email protected] no later than April 3, 2019. No commercial or promotional material will be permitted to be presented or distributed at the public meeting. If you need special accommodations due to a disability, please contact Chenoa Conley, 301-796-0035, email [email protected], no later than April 3, 2019. Transcripts: Please be advised that as soon as a transcript of the public meeting is available, it will accessible at https://www.regulations.gov. It may be viewed at the Dockets Management Staff (see ADDRESSES). A link to the transcript will also be available on the internet at https:/www.fda.gov/forindustry/userfees/ prescriptiondruguserfee/ucm446608.htm. Dated: November 26, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-25958 Filed 11-28-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 230 / Thursday, November 29, 2018 / Notices 61385
is an essential component of this section 423(a), the allotment ALLOTMENT—Continued
analytic method. percentages are one of the factors used
The information collected through the in the computation of the Federal grants State Percentage
survey will complement the existing awarded under the Program.
data by helping identify factors Utah ...................................... 57.96
DATES: The allotment percentages will
associated with ADE outcomes of Vermont ................................ 49.37
be effective for Federal Fiscal Years Virginia .................................. 46.44
interest from existing data sets such as 2020 and 2021. Washington ........................... 44.42
Medicare claims. For example, claims FOR FURTHER INFORMATION CONTACT: West Virginia ........................ 62.68
data can provide information on Daniel Jackson, Grants Fiscal Wisconsin ............................. 52.48
whether the number of prescriptions for Management Specialist, Office of Grants Wyoming ............................... 43.49
opioids has decreased, but not what has Management, Office of Administration, America Samoa .................... 70.00
helped to facilitate the decrease. Guam .................................... 70.00
Administration for Children and Puerto Rico ........................... 70.00
Subsequent to the 60-day Federal Families, 330 C St. SW, Washington, DC N. Mariana Islands ............... 70.00
Register notice which published on July 20201. Telephone: (202) 401–3446. Virgin Islands ........................ 70.00
20, 2018 (83 FR 34593), the collection Email: daniel.jackson@acf.hhs.gov.
instrument was revised to clarify SUPPLEMENTARY INFORMATION: The
wording on questions, adjust the Statutory Authority: Section 423(c) of the
allotment percentage for each State is Social Security Act (42 U.S.C. 623(c)).
methods for measuring attribution, and determined on the basis of paragraphs
nursing homes were removed from the (b) and (c) of section 423 of the Social Elizabeth Leo,
originally-proposed sample. These Security Act. These figures are available Grants Policy Specialist, Division of Grants
changes did not result in changes to on the ACF internet homepage at Policy, Office of Administration.
burden, as additional respondents will https://www.acf.hhs.gov/cb. The [FR Doc. 2018–25932 Filed 11–28–18; 8:45 am]
be recruited from the pharmacy and allotment percentage for each State is as BILLING CODE 4184–01–P
practice settings. Form Number: CMS– follows:
10675 (OMB control number: 0938–
NEW); Frequency: Annually; Affected ALLOTMENT DEPARTMENT OF HEALTH AND
Public: Private sector (Business or other HUMAN SERVICES
for-profits); Number of Respondents: State Percentage
1,200; Total Annual Responses: 1,200; Food and Drug Administration
Total Annual Hours: 300. (For policy Alabama ................................ 60.54 [Docket No. FDA–2018–N–4337]
questions regarding this collection Alaska ................................... 43.36
contact Nancy Sonnenfeld at 410–786– Arizona .................................. 59.19 Prescription Drug User Fee Act of
1294.) Arkansas ............................... 60.16 2017; Electronic Submissions and Data
California ............................... 42.50
Dated: November 26, 2018. Colorado ............................... 47.06
Standards; Announcement of Public
William N. Parham, III, Connecticut ........................... 30.25 Meeting; Request for Comments
Director, Paperwork Reduction Staff, Office Delaware ............................... 51.62 AGENCY: Food and Drug Administration,
of Strategic Operations and Regulatory District of Columbia .............. 30.00 HHS.
Affairs. Florida ................................... 53.73
Georgia ................................. 57.38 ACTION: Notice of public meeting;
[FR Doc. 2018–25978 Filed 11–28–18; 8:45 am] request for comments.
Hawaii ................................... 49.16
BILLING CODE 4120–01–P Idaho ..................................... 59.41
Illinois .................................... 47.37 SUMMARY: The Food and Drug
Indiana .................................. 56.44 Administration (FDA or Agency) is
DEPARTMENT OF HEALTH AND Iowa ...................................... 53.57 announcing the following public
HUMAN SERVICES Kansas .................................. 52.37 meeting entitled ‘‘Prescription Drug
Kentucky ............................... 60.43 User Fee Act of 2017; Electronic
Administration for Children and Louisiana .............................. 57.09 Submissions and Data Standards.’’ FDA
Families Maine .................................... 55.15 is also requesting public comments on
Maryland ............................... 41.34 the subject. The purpose of the meeting
Notice of Allotment Percentages to Massachusetts ...................... 34.73
Michigan ............................... 55.31 and the request for comments is to
States for Child Welfare Services State fulfill FDA’s commitment to seek
Minnesota ............................. 47.14
Grants; CFDA Number: 93.645 Mississippi ............................ 64.24 stakeholder input related to data
AGENCY: Children’s Bureau, Missouri ................................ 56.32 standards and the electronic submission
Administration on Children, Youth and Montana ................................ 55.77 system’s past performance, future
Nebraska .............................. 49.84 targets, emerging industry needs, and
Families, Administration for Children Nevada ................................. 55.23
and Families, Department of Health and technology initiatives. FDA will use the
New Hampshire .................... 42.83 information from the public meeting as
Human Services. New Jersey ........................... 37.84
well as from comments submitted to the
ACTION: Notice of biennial publication of New Mexico .......................... 61.06
New York .............................. 38.63 docket to provide input into data
allotment percentages for States under
North Carolina ...................... 57.20 standards initiatives, the FDA
the Title IV–B subpart 1, Stephanie
North Dakota ........................ 47.32 Information Technology (IT) Strategic
Tubbs Jones Child Welfare Services
Ohio ...................................... 54.67 Plan, and electronic submissions
khammond on DSK30JT082PROD with NOTICES
Program. Oklahoma ............................. 56.55 gateway target timeframes.
SUMMARY: As required by section 423(c) Oregon .................................. 53.59 DATES: The public meeting will be held
Pennsylvania ........................ 48.50
of the Social Security Act, the Rhode Island ........................ 48.88
on April 10, 2019, from 9 a.m. to 4 p.m.
Department is publishing the allotment South Carolina ...................... 59.65 Submit either electronic or written
percentage for each State under the Title South Dakota ........................ 51.47 comments by April 10, 2019. See the
IV–B Subpart 1, Stephanie Tubbs Jones Tennessee ............................ 56.03 SUPPLEMENTARY INFORMATION section for
Child Welfare Services Program. Under Texas .................................... 53.39 registration date and information.
VerDate Sep<11>2014 16:42 Nov 28, 2018 Jkt 247001 PO 00000 Frm 00013 Fmt 4703 Sfmt 4703 E:\FR\FM\29NON1.SGM 29NON1](https://thefederalregister.org/doc/83_FR_61615/page/1.svg)
![Federal Register / Vol. 83, No. 230 / Thursday, November 29, 2018 / Notices 61387
comment session and which topic(s) Waiver by Application Studies.’’ It Staff, FDA will post your comment, as
you would like to address. FDA will do describes study designs for generating well as any attachments, except for
its best to accommodate requests to data that supports both 510(k) clearance information submitted, marked and
make public comments. Individuals and and CLIA waiver. Use of the Dual 510(k) identified, as confidential, if submitted
organizations with common interests are and CLIA Waiver by Application as detailed in ‘‘Instructions.’’
urged to consolidate or coordinate their pathway is optional; however, FDA Instructions: All submissions received
presentations. Following the close of believes this pathway is in many must include the Docket No. FDA–
registration, FDA will determine the instances the least burdensome and 2017–D–5625 for ‘‘Recommendations
amount of time allotted to each fastest approach for manufacturers to for Dual 510(k) and CLIA Waiver by
presenter and the approximate time obtain a CLIA waiver in addition to Application Studies.’’ Received
each oral presentation is to begin and 510(k) clearance for new in vitro comments will be placed in the docket
will select and notify participants by diagnostic (IVD) devices. FDA believes and, except for those submitted as
March 27, 2019. All requests to make increased use of this pathway will speed ‘‘Confidential Submissions,’’ publicly
oral presentations must be received by up the process of bringing simple and viewable at https://www.regulations.gov
the close of registration at 11:59 on accurate IVD devices to CLIA waived or at the Dockets Management Staff
March 22, 2019, Eastern Time. If settings, which will better serve patients between 9 a.m. and 4 p.m., Monday
selected for presentation, any and providers. This draft guidance is through Friday.
presentation materials must be emailed not final nor is it in effect at this time. • Confidential Submissions—To
to cderdatastandards@fda.hhs.gov no DATES: Submit either electronic or submit a comment with confidential
later than April 3, 2019. No commercial written comments on the draft guidance information that you do not wish to be
or promotional material will be by February 27, 2019 to ensure that the made publicly available, submit your
permitted to be presented or distributed Agency considers your comment on this comments only as a written/paper
at the public meeting. draft guidance before it begins work on submission. You should submit two
If you need special accommodations the final version of the guidance. copies total. One copy will include the
due to a disability, please contact ADDRESSES: You may submit comments
information you claim to be confidential
Chenoa Conley, 301–796–0035, email on any guidance at any time as follows: with a heading or cover note that states
Chenoa.Conley@fda.hhs.gov, no later ‘‘THIS DOCUMENT CONTAINS
Electronic Submissions CONFIDENTIAL INFORMATION.’’ The
than April 3, 2019.
Transcripts: Please be advised that as Submit electronic comments in the Agency will review this copy, including
soon as a transcript of the public following way: the claimed confidential information, in
meeting is available, it will accessible at • Federal eRulemaking Portal: its consideration of comments. The
https://www.regulations.gov. Follow the second copy, which will have the
https://www.regulations.gov. It may be
instructions for submitting comments. claimed confidential information
viewed at the Dockets Management Staff
Comments submitted electronically, redacted/blacked out, will be available
(see ADDRESSES). A link to the transcript
including attachments, to https:// for public viewing and posted on
will also be available on the internet at
www.regulations.gov will be posted to https://www.regulations.gov. Submit
https:/www.fda.gov/forindustry/
the docket unchanged. Because your both copies to the Dockets Management
userfees/prescriptiondruguserfee/
comment will be made public, you are Staff. If you do not wish your name and
ucm446608.htm.
solely responsible for ensuring that your contact information to be made publicly
Dated: November 26, 2018. comment does not include any available, you can provide this
Leslie Kux, confidential information that you or a information on the cover sheet and not
Associate Commissioner for Policy. third party may not wish to be posted, in the body of your comments and you
[FR Doc. 2018–25958 Filed 11–28–18; 8:45 am] such as medical information, your or must identify this information as
BILLING CODE 4164–01–P anyone else’s Social Security number, or ‘‘confidential.’’ Any information marked
confidential business information, such as ‘‘confidential’’ will not be disclosed
as a manufacturing process. Please note except in accordance with 21 CFR 10.20
DEPARTMENT OF HEALTH AND that if you include your name, contact and other applicable disclosure law. For
HUMAN SERVICES information, or other information that more information about FDA’s posting
identifies you in the body of your of comments to public dockets, see 80
Food and Drug Administration comments, that information will be FR 56469, September 18, 2015, or access
[Docket No. FDA–2017–D–5625] posted on https://www.regulations.gov. the information at: https://www.gpo.gov/
• If you want to submit a comment fdsys/pkg/FR-2015-09-18/pdf/2015-
Recommendations for Dual 510(k) and with confidential information that you 23389.pdf.
Clinical Laboratory Improvement do not wish to be made available to the Docket: For access to the docket to
Amendments Waiver by Application public, submit the comment as a read background documents or the
Studies; Draft Guidance for Industry written/paper submission and in the electronic and written/paper comments
and Food and Drug Administration manner detailed (see ‘‘Written/Paper received, go to https://
Staff; Availability Submissions’’ and ‘‘Instructions’’). www.regulations.gov and insert the
docket number, found in brackets in the
AGENCY: Food and Drug Administration, Written/Paper Submissions heading of this document, into the
HHS. Submit written/paper submissions as ‘‘Search’’ box and follow the prompts
khammond on DSK30JT082PROD with NOTICES
ACTION: Notice of availability. follows: and/or go to the Dockets Management
• Mail/Hand Delivery/Courier (for Staff, 5630 Fishers Lane, Rm. 1061,
SUMMARY: The Food and Drug written/paper submissions): Dockets Rockville, MD 20852.
Administration (FDA or Agency) is Management Staff (HFA–305), Food and You may submit comments on any
announcing the availability of the draft Drug Administration, 5630 Fishers guidance at any time (see 21 CFR
guidance entitled ‘‘Recommendations Lane, Rm. 1061, Rockville, MD 20852. 10.115(g)(5)).
for Dual 510(k) and Clinical Laboratory • For written/paper comments An electronic copy of the guidance
Improvement Amendments (CLIA) submitted to the Dockets Management document is available for download
VerDate Sep<11>2014 16:42 Nov 28, 2018 Jkt 247001 PO 00000 Frm 00015 Fmt 4703 Sfmt 4703 E:\FR\FM\29NON1.SGM 29NON1](https://thefederalregister.org/doc/83_FR_61615/page/3.svg)
Document Created: 2018-11-28 23:44:37
Document Modified: 2018-11-28 23:44:37
| 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 of public meeting; request for comments. | |
| Dates | The public meeting will be held on April 10, 2019, from 9 a.m. to 4 p.m. Submit either electronic or written comments by April 10, 2019. See the SUPPLEMENTARY INFORMATION section for registration date and information. | |
| Contact | Chenoa Conley, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 1117, Silver Spring, MD 20993-0002, 301- 796-0035, [email protected], or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911. | |
| FR Citation | 83 FR 61385 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR