81 FR 12511 - Mass Spectrometry in the Clinic: Regulatory Considerations Surrounding Validation of Liquid Chromatography-Mass Spectrometry Based Devices; Public Workshop; Request for Comments
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 46 (March 9, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 46 (March 9, 2016)
| Page Range | 12511-12513 | |
| FR Document | 2016-05220 |
[Federal Register Volume 81, Number 46 (Wednesday, March 9, 2016)] [Notices] [Pages 12511-12513] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-05220] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-N-0610] Mass Spectrometry in the Clinic: Regulatory Considerations Surrounding Validation of Liquid Chromatography-Mass Spectrometry Based Devices; Public Workshop; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop; request for comments. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing the following public workshop entitled ``Mass Spectrometry in the Clinic: Regulatory Considerations Surrounding Validation of Liquid Chromatography-Mass Spectrometry Based Devices.'' The topics to be discussed are the specific analytical and clinical study designs and considerations for validation and use of liquid chromatography/mass- spectrometry (LC/MS)-based in vitro diagnostic devices (IVDs) in the clinical laboratory. The primary focus will be on the validation considerations with protein- and peptide-based LC/MS devices. DATES: The public workshop will be held on May 2, 2016, from 8:30 a.m. to 5 p.m. Submit either electronic or written comments on the public workshop by April 20, 2016. ADDRESSES: The public workshop will be held at FDA's White Oak Campus, 10903 New Hampshire Ave., Bldg. 31, Rm. 1503 (The Great Room), Silver Spring, MD 20993. Entrance for the 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 http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm. 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, [[Page 12512]] if submitted as detailed in ``Instructions.'' Instructions: All submissions received must include the Docket No. FDA-2016-N-0610 for the ``Mass Spectrometry in the Clinic: Regulatory Considerations Surrounding Validation of Liquid Chromatography-Mass Spectrometry Based Devices'' public workshop. 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: Julia Tait Lathrop, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5614, Silver Spring, MD 20993, 240-402- 5034, email: [email protected]. I. Background Innovations in liquid chromatography-mass spectrometry (LC/MS) technology have dramatically improved assay throughput and precision.\1\ FDA has cleared and approved several LC/MS- and MS-based devices as diagnostic tests, including assays for screening newborns for metabolic diseases, for identifying microbes from human cultures, and for measuring the concentrations of therapeutic drugs in blood. Currently, however, no LC/MS-based IVDs have been cleared or approved by FDA for measuring proteins and peptides. FDA would like to enhance engagement with the clinical LC/MS community concerning the development and validation of LC/MS-based devices and to work with the community toward developing guidelines for review that will be useful and relevant to both FDA and manufacturers. Prior to the workshop, FDA will place a discussion paper on file in the public docket (docket number found in brackets in the heading of this document) and will post it at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. --------------------------------------------------------------------------- \1\ LC/MS includes high-performance liquid chromatography, HPLC- MS. --------------------------------------------------------------------------- II. Topics for Discussion This public workshop will consist of brief presentations providing information to frame the goals of the workshop, followed by interactive panel discussions. The presentations will focus on current and anticipated uses for LC/MS and discussions of different validation approaches. Following the presentations, a moderated discussion will ask speakers and additional panelists to provide their individual perspectives. Examples of topics for discussion surrounding the challenges to validation that are specific to LC/MS-based protein and peptide IVDs include: Identifying pre-analytical and analytical variables that impact precision and reproducibility; Defining methods of normalization, harmonization, and the use of internal standards for quantitation and device calibration; Developing quality control materials; and Identifying appropriate reference materials and predicate devices. We are soliciting comments and feedback from the clinical LC/MS community regarding additional topics for FDA to consider. We anticipate that the comments and suggestions generated through this workshop will help facilitate the development of appropriate analytical and clinical validation methods for IVDs. The agenda of the workshop will include time for public comments. These comments can be submitted to the docket prior to the meeting (see ADDRESSES). Registration: Registration is free and early registration is recommended because facilities are limited and, therefore, FDA may limit the number of participants from each organization. Persons interested in attending this public workshop must register online by 4 p.m. on April 22, 2016. If time and space permit, onsite registration on the day of the public workshop will be provided beginning at 7:30 a.m. If you need special accommodations due to a disability, please contact Susan Monahan, 301-796-5661, [email protected], no later than April 15, 2016. To register for the public workshop, please visit FDA's Medical Devices News & Events--Workshops & Conferences calendar at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. (Select this public workshop from the posted events list.) Please provide complete contact information for each attendee, including name, title, affiliation, address, email, and telephone number. Those without Internet access should contact Susan Monahan (contact for special accommodations) to register. Registrants will receive confirmation after they have been accepted. You will be notified if you are on a waiting list. Streaming Webcast of the Public Workshop: This public workshop will also be Webcast. The Webcast link will be available on the registration Web page after April 25, 2016. If you have never attended a Connect Pro event before, test your connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get a quick overview of the Connect Pro program, visit http://www.adobe.com/go/connectpro_overview. FDA has verified the Web site addresses in this document, as of the date this document publishes in the Federal Register, but Web sites are subject to change over time. Requests for Oral Presentations: This public workshop includes a public comment session and topic-focused sessions. During online registration you may indicate if you wish to present during a public comment session or [[Page 12513]] participate in a specific session, and which topics you wish to address. FDA has included general topics in this document. FDA will do its best to accommodate requests to make public comments and participate in the focused sessions. Individuals and organizations with common interests are urged to consolidate or coordinate their presentations, and request time for a joint presentation, or submit requests for designated representatives to participate in the focused sessions. 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 April 24, 2016. All requests to make oral presentations must be received by the close of registration at 4 p.m. on April 22, 2016. If selected for presentation, any presentation materials must be emailed to Julia Tait Lathrop (see FOR FURTHER INFORMATION CONTACT) no later than April 29, 2016. No commercial or promotional material will be permitted to be presented or distributed at the public workshop. FDA is holding this public workshop to obtain information on current and anticipated uses for LC/MS as well as different validation approaches. In order to permit the widest possible opportunity to obtain public comment, FDA is soliciting either electronic or written comments on all aspects of the public workshop topics. For the deadline for submitting comments related to this public workshop, see DATES. Transcripts: Please be advised that as soon as a transcript is available, it will be accessible at http://www.regulations.gov. It may be viewed at the Division of Dockets Management (see ADDRESSES). A transcript will also be available in either hardcopy or on CD-ROM, after submission of a Freedom of Information request. The Freedom of Information office address is available on the Agency's Web site at http://www.fda.gov. A link to the transcripts will also be available approximately 45 days after the public workshop on the Internet at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. (Select this public workshop from the posted events list). Dated: March 3, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-05220 Filed 3-8-16; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 46 / Wednesday, March 9, 2016 / Notices 12511
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Number of
Number of Total annual Average burden
21 CFR section and activity responses per Total hours
respondents responses per response
respondent
Supplemental Feed Mill License Application Using 40 1 40 0.25 (15 minutes) 10
Form FDA 3448 (515.11(b)).
Voluntary Revocation of Medicated Feed Mill License 40 1 40 0.25 (15 minutes) 10
(515.23).
Filing a Request for a Hearing on Medicated Feed Mill 1 1 1 4 ......................... 4
License (515.30(c)).
Total ......................................................................... ........................ ........................ ........................ ............................ 29
1 ‘‘There are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of Average
Number of Total annual
21 CFR section and activity records per burden per Total hours
recordkeepers records
recordkeeper recordkeeping
Maintenance of Records for Approved Labeling for 890 1 890 0.03 (2 minutes) 26.7
Each ‘‘Type B’’ and ‘‘Type C’’ Feed (510.305).
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
These estimates are based on our SUMMARY: The Food and Drug • Federal eRulemaking Portal: http://
experience with medicated feed mill Administration (FDA) is announcing the www.regulations.gov. Follow the
license applications. We estimate that following public workshop entitled instructions for submitting comments.
we will receive 20 medicated feed mill ‘‘Mass Spectrometry in the Clinic: Comments submitted electronically,
license applications, 40 supplemental Regulatory Considerations Surrounding including attachments, to http://
applications, 40 requests for voluntary Validation of Liquid Chromatography- www.regulations.gov will be posted to
revocation, and that these submissions Mass Spectrometry Based Devices.’’ The the docket unchanged. Because your
will take approximately 15 minutes per topics to be discussed are the specific comment will be made public, you are
response, as shown in table 1, rows 1 analytical and clinical study designs solely responsible for ensuring that your
through 3. We estimate that preparing a and considerations for validation and comment does not include any
request for a hearing under 21 CFR use of liquid chromatography/mass- confidential information that you or a
515.30(c) takes approximately 4 hours, spectrometry (LC/MS)-based in vitro third party may not wish to be posted,
as shown in table 1, row 4. In table 2, diagnostic devices (IVDs) in the clinical such as medical information, your or
we estimate that 890 licensees will keep laboratory. The primary focus will be on anyone else’s Social Security number, or
the records required by 21 CFR 510.305 the validation considerations with confidential business information, such
expending a total of 26.7 hours protein- and peptide-based LC/MS as a manufacturing process. Please note
annually. devices. that if you include your name, contact
Dated: March 2, 2016. information, or other information that
DATES: The public workshop will be
identifies you in the body of your
Leslie Kux, held on May 2, 2016, from 8:30 a.m. to
comments, that information will be
Associate Commissioner for Policy. 5 p.m. Submit either electronic or
posted on http://www.regulations.gov.
written comments on the public
[FR Doc. 2016–05214 Filed 3–8–16; 8:45 am]
• If you want to submit a comment
BILLING CODE 4164–01–P workshop by April 20, 2016.
with confidential information that you
ADDRESSES: The public workshop will do not wish to be made available to the
be held at FDA’s White Oak Campus, public, submit the comment as a
DEPARTMENT OF HEALTH AND 10903 New Hampshire Ave., Bldg. 31, written/paper submission and in the
HUMAN SERVICES Rm. 1503 (The Great Room), Silver manner detailed (see ‘‘Written/Paper
Spring, MD 20993. Entrance for the Submissions’’ and ‘‘Instructions’’).
Food and Drug Administration public meeting participants (non-FDA
employees) is through Building 1, where Written/Paper Submissions
[Docket No. FDA–2016–N–0610] routine security check procedures will Submit written/paper submissions as
be performed. For parking and security follows:
Mass Spectrometry in the Clinic: information, please refer to http:// • Mail/Hand delivery/Courier (for
Regulatory Considerations www.fda.gov/AboutFDA/ written/paper submissions): Division of
Surrounding Validation of Liquid WorkingatFDA/BuildingsandFacilities/ Dockets Management (HFA–305), Food
Chromatography-Mass Spectrometry WhiteOakCampusInformation/ and Drug Administration, 5630 Fishers
Based Devices; Public Workshop;
Lhorne on DSK5TPTVN1PROD with NOTICES
ucm241740.htm. Lane, Rm. 1061, Rockville, MD 20852.
Request for Comments You may submit comments as • For written/paper comments
AGENCY: Food and Drug Administration, follows: submitted to the Division of Dockets
HHS. Management, FDA will post your
Electronic Submissions
comment, as well as any attachments,
ACTION: Notice of public workshop;
Submit electronic comments in the except for information submitted,
request for comments.
following way: marked and identified, as confidential,
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![Federal Register / Vol. 81, No. 46 / Wednesday, March 9, 2016 / Notices 12513
participate in a specific session, and DEPARTMENT OF HEALTH AND including the applicable Medicaid State
which topics you wish to address. FDA HUMAN SERVICES plan.
has included general topics in this Dated: March 3, 2016.
document. FDA will do its best to Indian Health Service
Mary Smith,
accommodate requests to make public
comments and participate in the Reimbursement Rates for Calendar Principal Deputy Director, Indian Health
Year 2016 Service.
focused sessions. Individuals and
[FR Doc. 2016–05252 Filed 3–8–16; 8:45 am]
organizations with common interests are AGENCY: Indian Health Service, HHS.
urged to consolidate or coordinate their ACTION: Notice.
BILLING CODE 4160–16–P
presentations, and request time for a
joint presentation, or submit requests for SUMMARY: Notice is given that the
designated representatives to participate Principal Deputy Director of the Indian DEPARTMENT OF HEALTH AND
in the focused sessions. Following the Health Service (IHS), under the HUMAN SERVICES
close of registration, FDA will authority of sections 321(a) and 322(b)
of the Public Health Service Act (42 National Institutes of Health
determine the amount of time allotted to
each presenter and the approximate U.S.C. 248 and 249(b)), Public Law 83–
568 (42 U.S.C. 2001(a)), and the Indian National Center for Complementary
time each oral presentation is to begin, and Integrative Health; Notice of
and will select and notify participants Health Care Improvement Act (25 U.S.C.
1601 et seq.), has approved the Closed Meeting
by April 24, 2016. All requests to make
oral presentations must be received by following rates for inpatient and
outpatient medical care provided by IHS Pursuant to section 10(d) of the
the close of registration at 4 p.m. on Federal Advisory Committee Act, as
facilities for Calendar Year 2016 for
April 22, 2016. If selected for amended (5 U.S.C. App.), notice is
Medicare and Medicaid beneficiaries,
presentation, any presentation materials hereby given of the following meeting.
beneficiaries of other Federal programs,
must be emailed to Julia Tait Lathrop
and for recoveries under the Federal The meeting will be closed to the
(see FOR FURTHER INFORMATION CONTACT) Medical Care Recovery Act (42 U.S.C. public in accordance with the
no later than April 29, 2016. No 2651–2653). The Medicare Part A provisions set forth in sections
commercial or promotional material inpatient rates are excluded from the 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
will be permitted to be presented or table below as they are paid based on as amended. The grant applications and
distributed at the public workshop. the prospective payment system. Since the discussions could disclose
FDA is holding this public workshop the inpatient per diem rates set forth confidential trade secrets or commercial
to obtain information on current and below do not include all physician property such as patentable material,
anticipated uses for LC/MS as well as services and practitioner services, and personal information concerning
different validation approaches. In order additional payment shall be available to individuals associated with the grant
to permit the widest possible the extent that those services are applications, the disclosure of which
opportunity to obtain public comment, provided.
would constitute a clearly unwarranted
FDA is soliciting either electronic or invasion of personal privacy.
written comments on all aspects of the INPATIENT HOSPITAL PER DIEM RATE
public workshop topics. For the (EXCLUDES PHYSICIAN/PRACTI- Name of Committee: National Center for
TIONER SERVICES) Complementary and Integrative Health
deadline for submitting comments
Special Emphasis Panel; Mind and Body
related to this public workshop, see [Calendar year 2016]
Interventions.
DATES.
Date: April 8, 2016.
Transcripts: Please be advised that as Lower 48 States ................ $2,655 Time: 8:00 a.m. to 8:00 p.m.
Alaska ............................... 3,335
soon as a transcript is available, it will Agenda: To review and evaluate grant
Outpatient per Visit Rate
be accessible at http:// (Excluding Medicare): applications.
www.regulations.gov. It may be viewed Lower 48 States ................ 368 Place: Bethesda North Marriott Hotel &
at the Division of Dockets Management Alaska ............................... 603 Conference Center, 5701 Marinelli Road,
(see ADDRESSES). A transcript will also Outpatient Per Visit Rate Bethesda, MD 20852.
be available in either hardcopy or on (Medicare): Contact Person: Martina Schmidt, Ph.D.,
CD–ROM, after submission of a Lower 48 States ................ 324 Scientific Review Officer, Office of Scientific
Freedom of Information request. The Alaska ............................... 582 Review, National Center for Complementary
Medicare Part B Inpatient and Integrative Health, NIH, 6707 Democracy
Freedom of Information office address is Ancillary Per Diem Rate:
available on the Agency’s Web site at Blvd., Suite 401, Bethesda, MD 20892, 301–
Lower 48 States ................ 637 594–3456, schmidma@mail.nih.gov.
http://www.fda.gov. A link to the Alaska ............................... 1,082
transcripts will also be available Outpatient Surgery Rate (Catalogue of Federal Domestic Assistance
approximately 45 days after the public (Medicare): Program Nos. 93.213, Research and Training
workshop on the Internet at http:// Established Medicare rates in Complementary and Alternative Medicine,
www.fda.gov/MedicalDevices/ for freestanding Ambula- National Institutes of Health, HHS)
tory Surgery Centers..
NewsEvents/WorkshopsConferences/
Dated: March 3, 2016.
default.htm. (Select this public
Effective Date for Calendar Year 2016 Michelle Trout,
Lhorne on DSK5TPTVN1PROD with NOTICES
workshop from the posted events list).
Rates Program Analyst, Office of Federal Advisory
Dated: March 3, 2016. Committee Policy.
Consistent with previous annual rate
Leslie Kux, [FR Doc. 2016–05197 Filed 3–8–16; 8:45 am]
revisions, the Calendar Year 2016 rates
Associate Commissioner for Policy. will be effective for services provided BILLING CODE 4140–01–P
[FR Doc. 2016–05220 Filed 3–8–16; 8:45 am] on/or after January 1, 2016 to the extent
BILLING CODE 4164–01–P consistent with payment authorities
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Document Created: 2016-03-09 00:13:00
Document Modified: 2016-03-09 00:13:00
| 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 workshop; request for comments. | |
| Dates | The public workshop will be held on May 2, 2016, from 8:30 a.m. to 5 p.m. Submit either electronic or written comments on the public workshop by April 20, 2016. | |
| Contact | Julia Tait Lathrop, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5614, Silver Spring, MD 20993, 240-402- 5034, email: [email protected] | |
| FR Citation | 81 FR 12511 |
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