80 FR 46032 - Recommendations for Premarket Notification (510(k)) Submissions for Nucleic Acid-Based Human Leukocyte Antigen Test Kits Used for Matching of Donors and Recipients in Transfusion and Transplantation; Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 148 (August 3, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 148 (August 3, 2015)
| Page Range | 46032-46033 | |
| FR Document | 2015-18956 |
[Federal Register Volume 80, Number 148 (Monday, August 3, 2015)] [Notices] [Pages 46032-46033] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-18956] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-D-1358] Recommendations for Premarket Notification (510(k)) Submissions for Nucleic Acid-Based Human Leukocyte Antigen Test Kits Used for Matching of Donors and Recipients in Transfusion and Transplantation; Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a document entitled ``Recommendations for Premarket Notification (510(k)) Submissions for Nucleic Acid-Based Human Leukocyte Antigen (HLA) Test Kits Used for Matching of Donors and Recipients in Transfusion and Transplantation; Guidance for Industry.'' The guidance document provides recommendations to submitters and FDA reviewers in preparing and reviewing premarket notification submissions (hereafter referred to as ``510(k) submission'' or ``510(k)'') for HLA in vitro diagnostic (IVD) device test kits. The guidance applies specifically to nucleic acid-based HLA test kits used for the matching of donors and recipients in transfusion and transplantation, whether testing is for a single locus or for multiple loci simultaneously, for which the premarket submission to FDA will be a 510(k). The guidance announced in this notice finalizes the draft guidance of the same title dated November 2013. DATES: Submit either electronic or written comments on Agency guidances at any time. ADDRESSES: Submit written requests for single copies of the guidance to the Office of Communication, Outreach, and Development, Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993- 0002. Send one self-addressed adhesive label to assist the office in processing your requests. The guidance may also be obtained by mail by calling CBER at 1-800-835-4709 or 240-402-7800. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Valerie A. Butler, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a document entitled ``Recommendations for Premarket Notification (510(k)) Submissions for Nucleic Acid-Based Human Leukocyte Antigen Test Kits Used for Matching of Donors and Recipients in Transfusion and Transplantation; Guidance for Industry.'' The guidance provides recommendations to submitters and FDA reviewers in preparing and reviewing 510(k) submissions for IVD device test kits, specifically for nucleic acid-based HLA test kits used for the matching of donors and recipients in transfusion and transplantation, whether testing is for a single locus or for multiple loci simultaneously. The guidance includes detailed information on the types of studies FDA recommends for validation of HLA test kits submitted as 510(k)s. More specifically, the guidance document addresses the types of studies and other information that FDA recommends to be used in designing and conducting studies for validation of nucleic acid-based HLA test kits and preparing a 510(k) submission. In the Federal Register of November 20, 2013 (78 FR 69693), FDA announced the availability of the draft guidance of the same title dated November 2013. FDA received several comments on the draft guidance and those comments were considered as the guidance was finalized. In addition, editorial changes were made for purposes of clarity and accuracy. The guidance announced in this notice finalizes the draft guidance dated November 2013. The guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on premarket notification (510(k)) submissions for nucleic acid-based HLA test kits used for matching of donors and recipients in transfusion and transplantation. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. II. Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR part 807, subpart E have been approved under OMB control number 0910-0120; the collections of information in 21 CFR part 809 have been approved under OMB control number 0910-0485; the collections of information in 21 CFR part 812 have been approved under OMB control numbers 0910-0078 and 0910-0582; the collections of information in 21 CFR part 820 have been approved under OMB control number 0910-0073; the collections of information in 21 CFR part 56 have been approved under OMB control number 0910-0130; and the collections of information in 21 CFR part 50 have been approved under OMB control number 0910-0586. III. Comments Interested persons may submit either electronic comments regarding this document to http://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the [[Page 46033]] heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov. IV. Electronic Access Persons with access to the Internet may obtain the guidance at either http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov. Dated: July 29, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-18956 Filed 7-31-15; 8:45 am] BILLING CODE 4164-01-P
![46032 Federal Register / Vol. 80, No. 148 / Monday, August 3, 2015 / Notices
Application fees can also be paid transfusion and transplantation, information that FDA recommends to be
online with an electronic check (ACH). whether testing is for a single locus or used in designing and conducting
FDA has partnered with the U.S. for multiple loci simultaneously, for studies for validation of nucleic acid-
Department of the Treasury to use which the premarket submission to FDA based HLA test kits and preparing a
Pay.gov, a Web-based payment will be a 510(k). The guidance 510(k) submission.
application, for online electronic announced in this notice finalizes the In the Federal Register of November
payment. The Pay.gov feature is draft guidance of the same title dated 20, 2013 (78 FR 69693), FDA announced
available on the FDA Web site after the November 2013. the availability of the draft guidance of
user fee ID number is generated. DATES: Submit either electronic or the same title dated November 2013.
The tax identification number of FDA written comments on Agency guidances FDA received several comments on the
is 53–0196965. at any time. draft guidance and those comments
ADDRESSES: Submit written requests for
were considered as the guidance was
B. Establishment and Product Fees
single copies of the guidance to the finalized. In addition, editorial changes
FDA will issue invoices for were made for purposes of clarity and
establishment and product fees for FY Office of Communication, Outreach, and
accuracy. The guidance announced in
2016 under the new fee schedule in Development, Center for Biologics
this notice finalizes the draft guidance
August 2015. Payment will be due on Evaluation and Research (CBER), Food
dated November 2013.
October 1, 2015. FDA will issue and Drug Administration, 10903 New The guidance is being issued
invoices in November 2016 for any Hampshire Ave., Bldg. 71, Rm. 3128, consistent with FDA’s good guidance
products and establishments subject to Silver Spring, MD 20993–0002. Send practices regulation (21 CFR 10.115).
fees for FY 2016 that qualify for fee one self-addressed adhesive label to The guidance represents the current
assessments after the August 2015 assist the office in processing your thinking of FDA on premarket
billing. requests. The guidance may also be notification (510(k)) submissions for
obtained by mail by calling CBER at 1– nucleic acid-based HLA test kits used
Dated: July 28, 2015.
800–835–4709 or 240–402–7800. See for matching of donors and recipients in
Leslie Kux, the SUPPLEMENTARY INFORMATION section
Associate Commissioner for Policy. transfusion and transplantation. It does
for electronic access to the guidance not establish any rights for any person
[FR Doc. 2015–18914 Filed 7–31–15; 8:45 am] document. and is not binding on FDA or the public.
BILLING CODE 4164–01–P Submit electronic comments on the You can use an alternative approach if
guidance to http://www.regulations.gov. it satisfies the requirements of the
Submit written comments to the applicable statutes and regulations.
DEPARTMENT OF HEALTH AND Division of Dockets Management (HFA–
HUMAN SERVICES 305), Food and Drug Administration, II. Paperwork Reduction Act of 1995
5630 Fishers Lane, Rm. 1061, Rockville, This guidance refers to previously
Food and Drug Administration MD 20852. approved collections of information
[Docket No. FDA–2013–D–1358] FOR FURTHER INFORMATION CONTACT: found in FDA regulations. These
Valerie A. Butler, Center for Biologics collections of information are subject to
Recommendations for Premarket Evaluation and Research, Food and review by the Office of Management and
Notification (510(k)) Submissions for Drug Administration, 10903 New Budget (OMB) under the Paperwork
Nucleic Acid-Based Human Leukocyte Hampshire Ave., Bldg. 71, Rm. 7301, Reduction Act of 1995 (44 U.S.C. 3501–
Antigen Test Kits Used for Matching of Silver Spring, MD 20993–0002, 240– 3520). The collections of information in
Donors and Recipients in Transfusion 402–7911. 21 CFR part 807, subpart E have been
and Transplantation; Guidance for
SUPPLEMENTARY INFORMATION: approved under OMB control number
Industry; Availability
0910–0120; the collections of
I. Background
AGENCY: Food and Drug Administration, information in 21 CFR part 809 have
HHS. FDA is announcing the availability of been approved under OMB control
ACTION: Notice. a document entitled ‘‘Recommendations number 0910–0485; the collections of
for Premarket Notification (510(k)) information in 21 CFR part 812 have
SUMMARY: The Food and Drug Submissions for Nucleic Acid-Based been approved under OMB control
Administration (FDA or Agency) is Human Leukocyte Antigen Test Kits numbers 0910–0078 and 0910–0582; the
announcing the availability of a Used for Matching of Donors and collections of information in 21 CFR
document entitled ‘‘Recommendations Recipients in Transfusion and part 820 have been approved under
for Premarket Notification (510(k)) Transplantation; Guidance for OMB control number 0910–0073; the
Submissions for Nucleic Acid-Based Industry.’’ The guidance provides collections of information in 21 CFR
Human Leukocyte Antigen (HLA) Test recommendations to submitters and part 56 have been approved under OMB
Kits Used for Matching of Donors and FDA reviewers in preparing and control number 0910–0130; and the
Recipients in Transfusion and reviewing 510(k) submissions for IVD collections of information in 21 CFR
Transplantation; Guidance for device test kits, specifically for nucleic part 50 have been approved under OMB
Industry.’’ The guidance document acid-based HLA test kits used for the control number 0910–0586.
provides recommendations to matching of donors and recipients in
submitters and FDA reviewers in transfusion and transplantation, III. Comments
mstockstill on DSK4VPTVN1PROD with NOTICES
preparing and reviewing premarket whether testing is for a single locus or Interested persons may submit either
notification submissions (hereafter for multiple loci simultaneously. The electronic comments regarding this
referred to as ‘‘510(k) submission’’ or guidance includes detailed information document to http://www.regulations.gov
‘‘510(k)’’) for HLA in vitro diagnostic on the types of studies FDA or written comments to the Division of
(IVD) device test kits. The guidance recommends for validation of HLA test Dockets Management (see ADDRESSES). It
applies specifically to nucleic acid- kits submitted as 510(k)s. More is only necessary to send one set of
based HLA test kits used for the specifically, the guidance document comments. Identify comments with the
matching of donors and recipients in addresses the types of studies and other docket number found in brackets in the
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![Federal Register / Vol. 80, No. 148 / Monday, August 3, 2015 / Notices 46033
heading of this document. Received making your submission to FDA, you From this starting point, this document
comments may be seen in the Division will have to pay the higher standard fee. establishes FY 2016 fee rates for other
of Dockets Management between 9 a.m. Please note that the establishment types of submissions, and for periodic
and 4 p.m., Monday through Friday, and registration fee is not eligible for a reporting, by applying criteria specified
will be posted to the docket at http:// reduced small business fee. As a result, in the FD&C Act.
www.regulations.gov. if the establishment registration fee is The FD&C Act specifies the base fee
the only medical device user fee that for establishment registration for each
IV. Electronic Access you will pay in FY 2016, you should not year from FY 2013 through FY 2017; the
Persons with access to the Internet submit a FY 2016 Small Business base fee for an establishment
may obtain the guidance at either http:// Qualification and Certification request. registration in FY 2016 is $3,872. There
www.fda.gov/BiologicsBloodVaccines/ This document provides information on is no reduction in the registration fee for
GuidanceComplianceRegulatory how the fees for FY 2016 were small businesses. Each establishment
Information/Guidances/default.htm or determined, the payment procedures that is registered (or is required to
http://www.regulations.gov. you should follow, and how you may register) with the Secretary under
Dated: July 29, 2015. qualify for reduced small business fees. section 510 of the FD&C Act (21 U.S.C.
Leslie Kux, FOR FURTHER INFORMATION CONTACT: For 360) because such establishment is
Associate Commissioner for Policy. information on Medical Device User engaged in the manufacture,
[FR Doc. 2015–18956 Filed 7–31–15; 8:45 am]
Fees: Visit FDA’s Web site at http:// preparation, propagation, compounding,
www.fda.gov/mdufa. or processing of a device is required to
BILLING CODE 4164–01–P
For questions relating to this notice: pay the annual fee for establishment
David Miller, Office of Financial registration.
Management, Food and Drug
DEPARTMENT OF HEALTH AND II. Revenue Amount for FY 2016
Administration, 8455 Colesville Rd.
HUMAN SERVICES
(COLE–14202E), Silver Spring, MD The total revenue amount for FY 2016
Food and Drug Administration 20993–0002, 301–796–7103. is $129,339,949, as set forth in the
SUPPLEMENTARY INFORMATION: statute prior to the inflation adjustment.
[Docket No. FDA–2015–N–0007]
I. Background (See 21 U.S.C. 379j(b)(3)(D)). MDUFA III
Medical Device User Fee Rates for (Pub. L. 112–144) directs FDA to use the
Section 738 of the FD&C Act (21 yearly total revenue amount as a starting
Fiscal Year 2016 U.S.C. 379j) establishes fees for certain point to set the standard fee rates for
AGENCY: Food and Drug Administration, medical device applications, each fee type. The fee calculations for
HHS. submissions, supplements, and notices FY 2016 are described in this document.
ACTION: Notice. (for simplicity, this document refers to
these collectively as ‘‘submissions’’ or Inflation Adjustment
SUMMARY: The Food and Drug ‘‘applications’’); for periodic reporting
Administration (FDA) is announcing the MDUFA III specifies that the
on class III devices; and for the
fee rates and payment procedures for $129,339,949 is to be adjusted for
registration of certain establishments.
medical device user fees for fiscal year inflation increases for FY 2016 using
Under statutorily defined conditions, a
(FY) 2016. The Federal Food, Drug, and two separate adjustments—one for
qualified applicant may receive a fee
Cosmetic Act (the FD&C Act), as payroll costs and one for non-pay costs
waiver or may pay a lower small
amended by the Medical Device User (see 21 U.S.C. 379j(c)(2)). The base
business fee. (See 21 U.S.C. 379j(d) and
Fee Amendments of 2012 (MDUFA III), inflation adjustment for FY 2016 is the
(e).) Additionally, the Secretary of
authorizes FDA to collect user fees for sum of one plus these two separate
Health and Human Services (the
certain medical device submissions and adjustments, and is compounded as
Secretary) may, at the Secretary’s sole
annual fees both for certain periodic specified (see 21 U.S.C. 379j(c)(2)(C)(1)
discretion, grant a fee waiver or
reports and for establishments subject to and 379j(c)(2)(B)(ii)).
reduction if the Secretary finds that
registration. This notice establishes the such waiver or reduction is in the The component of the inflation
fee rates for FY 2016, which apply from interest of public health. (See 21 U.S.C. adjustment for payroll costs is the
October 1, 2015, through September 30, 379j(f).) average annual percent change in the
2016. To avoid delay in the review of Under the FD&C Act, the fee rate for cost of all personnel compensation and
your application, you should pay the each type of submission is set at a benefits (PC&B) paid per full-time
application fee before or at the time you specified percentage of the standard fee equivalent position (FTE) at FDA for the
submit your application to FDA. The fee for a premarket application (a premarket first 3 of the 4 preceding FYs,
you must pay is the fee that is in effect application is a premarket approval multiplied by 0.60, or 60 percent (see 21
on the later of the date that your application (PMA), a product U.S.C. 379j(c)(2)(C)).
application is received by FDA or the development protocol (PDP), or a Table 1 summarizes the actual cost
date your fee payment is recognized by biologics license application (BLA)). and FTE data for the specified FYs, and
the U.S. Treasury. If you want to pay a The FD&C Act specifies the base fee for provides the percent change from the
reduced small business fee, you must a premarket application for each year previous FY and the average percent
qualify as a small business before from FY 2013 through FY 2017; the base change over the first 3 of the 4 FYs
making your submission to FDA; if you fee for a premarket application received preceding FY 2016. The 3-year average
mstockstill on DSK4VPTVN1PROD with NOTICES
do not qualify as a small business before by FDA during FY 2016 is $263,180. is 2.2328 percent (rounded).
TABLE 1—FDA PC&BS EACH YEAR AND PERCENT CHANGE
Fiscal year 2012 2013 2014 3-Year average
Total PC&B .............................................................................. $1,824,703,000 $1,927,703,000 $2,054,937,000
Total FTE ................................................................................. 13,382 13,974 14,555
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Document Created: 2018-02-23 10:51:46
Document Modified: 2018-02-23 10:51:46
| 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 Agency guidances at any time. | |
| Contact | Valerie A. Butler, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911. | |
| FR Citation | 80 FR 46032 |
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