81 FR 11576 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device User Fee Small Business Qualification and Certification
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 43 (March 4, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 43 (March 4, 2016)
| Page Range | 11576-11577 | |
| FR Document | 2016-04704 |
[Federal Register Volume 81, Number 43 (Friday, March 4, 2016)] [Notices] [Pages 11576-11577] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-04704] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-N-3287] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device User Fee Small Business Qualification and Certification AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of information by April 4, 2016. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, or emailed to [email protected]. All comments should be identified with the OMB control number 0910-0508 and title ``Medical Device User Fee Small Business Qualification and Certification.'' Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected]. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. Medical Device User Fee Small Business Qualification and Certification OMB Control Number 0910-0508--Extension Section 101 of the Medical Device User Fee and Modernization Act (MDUFMA) (Pub. L. 107-250) amends the Federal Food, Drug, and Cosmetic Act, to provide for user fees for certain medical device applications. FDA published a Federal Register notice on August 3, 2015 (80 FR 46033), announcing fees for fiscal year (FY) 2016. To avoid harming small businesses, MDUFMA provides for reduced or waived fees for applicants who qualify as a small business. This means there are two levels of fees; a standard fee and a reduced or waived small business fee. You can qualify for a small business fee discount under MDUFMA if you reported gross receipts or sales of no more than $100 million on your Federal income tax return for the most recent tax year. If you have any affiliates, partners, or parent firms, you must add their gross receipts or sales to yours, and the total must be no more than $100 million. If your gross receipts or sales are no more than $30 million, including all of your affiliates, partners, and parent firms, you will also qualify for a waiver of the fee for your first (ever) premarket application (product development protocol, biologics licensing application, or premarket report). An applicant must pay the full standard fee unless it provides evidence demonstrating to FDA that it meets the small business criteria (Form FDA 3602, ``FY 2016 MDUFMA Small Business Qualification Certification--For a Business Headquartered in the United [[Page 11577]] States''). The evidence required by MDUFMA is a copy of the most recent Federal income tax return of the applicant, and any affiliate, partner, or parent firm. FDA will review these materials and decide whether an applicant is a small business within the meaning of MDUFMA. The 2007 Amendments provide an alternative way for a foreign business to qualify as a small business eligible to pay a significantly lower fee when a medical device user fee must be paid (Form FDA 3602A, ``FY 2016 MDUFMA Foreign Small Business Qualification Certification-- For a Business Headquartered Outside the United States''). Before passage of the 2007 Amendments, the only way a business could qualify as a small business was to submit a Federal (U.S.) income tax return showing its gross receipts or sales that did not exceed a statutory threshold, currently, $100 million. If a business could not provide a Federal income tax return, it did not qualify as a small business and had to pay the standard (full) fee. Because many foreign businesses have not, and cannot, file a Federal (U.S.) income tax return, this requirement has effectively prevented those businesses from qualifying for the small business fee rates. Thus, foreign governments, including the European Union, have objected. In lieu of a Federal income tax return, the 2007 Amendments will allow a foreign business to qualify as a small business by submitting a certification from its national taxing authority, the foreign equivalent of our Internal Revenue Service. This certification, referred to as a ``National Taxing Authority Certification,'' must: (1) Be in English; (2) be from the national taxing authority of the country in which the business is headquartered; (3) provide the business' gross receipts or sales for the most recent year, in both the local currency and in U.S. dollars, and the exchange rate used in converting local currency to U.S. dollars; (4) provide the dates during which the reported receipts or sales were collected; and (5) bear the official seal of the national taxing authority. Both Forms FDA 3602 and FDA 3602A are available in the guidance document, ``FY 2016 Medical Device User Fee Small Business Qualification and Certification; Guidance for Industry, Food and Drug Administration Staff, and Foreign Governments'' available on the Internet at: http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-gen/documents/document/ucm456779.pdf. This guidance describes the criteria FDA will use to decide whether an entity qualifies as a MDUFMA small business and will help prospective applicants understand what they need to do to meet the small business criteria for FY 2016. The estimated burden is based on the number of applications received in the last 3 years and includes time required to collect the required information. Based on our experience with Form FDA 3602, FDA believes it will take each respondent 1 hour to complete the form. Based on our experience with Form FDA 3602A, FDA also believes that it will take each respondent 1 hour to complete. In the Federal Register of September 17, 2015 (80 FR 55854), FDA published a 60-day notice requesting public comment on the proposed collection of information. Although one comment was received, it was not responsive to the four collection of information topics solicited and therefore will not be discussed in this document. FDA estimates the burden of this collection of information as follows: Table 1--Estimated Annual Reporting Burden \1\ ---------------------------------------------------------------------------------------------------------------- Number of Average FDA Form No. Number of responses per Total annual burden per Total hours respondents respondent responses response ---------------------------------------------------------------------------------------------------------------- FDA 3602--FY 2016 MDUFA Small 3,600 1 3,600 1 3,600 Business Qualification and Certification For a Business Headquartered in the United States......................... FDA 3602A--FY 2016 MDUFA Foreign 1,400 1 1,400 1 1,400 Small Business Qualification and Certification For a Business Headquartered Outside the United States.............. ------------------------------------------------------------------------------- Total....................... .............. .............. .............. .............. 5,000 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: February 29, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-04704 Filed 3-3-16; 8:45 am] BILLING CODE 4164-01-P
![11576 Federal Register / Vol. 81, No. 43 / Friday, March 4, 2016 / Notices
56469, September 18, 2015, or access does not specifically recommend its use. OMB recommends that written
the information at: http://www.fda.gov/ Although the Guide does not specify comments be faxed to the Office of
regulatoryinformation/dockets/ specific SDRGs for clinical and Information and Regulatory Affairs,
default.htm. nonclinical studies, PhUSE project OMB, Attn: FDA Desk Officer, FAX:
Docket: For access to the docket to groups have created separate clinical 202–395–7285, or emailed to oira_
read background documents or the and nonclinical studies templates. This submission@omb.eop.gov. All
electronic and written/paper comments notice applies specifically to the comments should be identified with the
received, go to http:// nonclinical SDRG template. A separate OMB control number 0910–0508 and
www.regulations.gov and insert the notice was issued for the clinical SDRG title ‘‘Medical Device User Fee Small
docket number, found in brackets in the template in July 2015 (see ‘‘Intent to Business Qualification and
heading of this document, into the Review a Study Data Reviewer’s Guide Certification.’’ Also include the FDA
‘‘Search’’ box and follow the prompts Template’’ (80 FR 43779, July 23, docket number found in brackets in the
and/or go to the Division of Dockets 2015)). heading of this document.
Management, 5630 Fishers Lane, Rm. FDA now intends to review the FOR FURTHER INFORMATION CONTACT: FDA
1061, Rockville, MD 20852. PhUSE Nonclinical SDRG template, a PRA Staff, Office of Operations, Food
FOR FURTHER INFORMATION CONTACT: deliverable of the working group effort and Drug Administration, 8455
Crystal Allard, Center for Drug described previously in this document, Colesville Rd., COLE–14526, Silver
Evaluation and Research, Food and with the potential result that FDA could Spring, MD 20993–0002, PRAStaff@
Drug Administration, 10903 New recommend the use of the template in fda.hhs.gov.
Hampshire Ave., Bldg. 21, Rm. 1518, its current form, or in a modified form, SUPPLEMENTARY INFORMATION: In
Silver Spring, MD 20993–0002, 301– for use in the regulatory submission of compliance with 44 U.S.C. 3507, FDA
796–8856, crystal.allard@fda.hhs.gov. study data in conformance with the has submitted the following proposed
SUPPLEMENTARY INFORMATION:
Guide. FDA invites public comment on collection of information to OMB for
all matters regarding the use of the review and clearance.
I. Background PhUSE Nonclinical SDRG template.
Medical Device User Fee Small
FDA is a participating member of II. Electronic Access Business Qualification and Certification
PhUSE, an independent, non-profit
consortium of academic, regulatory, The PhUSE Nonclinical SDRG OMB Control Number 0910–0508—
non-profit, and private sector entities. template is available at http:// Extension
PhUSE provides a global platform for www.phusewiki.org/wiki/
index.php?title=Study_Data_ Section 101 of the Medical Device
the discussion of topics encompassing User Fee and Modernization Act
the work of biostatisticians, data Reviewer’s_Guide.
(MDUFMA) (Pub. L. 107–250) amends
managers, statistical programmers, and Dated: February 29, 2016. the Federal Food, Drug, and Cosmetic
e-clinical information technology Leslie Kux, Act, to provide for user fees for certain
professionals, with the mission of Associate Commissioner for Policy. medical device applications. FDA
providing an open, transparent, and [FR Doc. 2016–04791 Filed 3–3–16; 8:45 am] published a Federal Register notice on
collaborative forum to address BILLING CODE 4164–01–P August 3, 2015 (80 FR 46033),
computational science issues. As part of announcing fees for fiscal year (FY)
this collaboration, PhUSE working 2016. To avoid harming small
groups develop and periodically publish DEPARTMENT OF HEALTH AND businesses, MDUFMA provides for
proposals for enhancing the review and HUMAN SERVICES reduced or waived fees for applicants
analysis of human and animal study who qualify as a small business. This
data submitted to regulatory agencies. Food and Drug Administration means there are two levels of fees; a
You can learn more about PhUSE [Docket No. FDA–2015–N–3287] standard fee and a reduced or waived
working groups at http://www.phuse.eu/ small business fee. You can qualify for
cs-working-groups.aspx. (FDA has Agency Information Collection a small business fee discount under
verified the Web site addresses, as of the Activities; Submission for Office of MDUFMA if you reported gross receipts
date this document publishes in the Management and Budget Review; or sales of no more than $100 million
Federal Register, but Web sites are Comment Request; Medical Device on your Federal income tax return for
subject to change over time.) User Fee Small Business Qualification the most recent tax year. If you have any
In December 2014, FDA published the and Certification affiliates, partners, or parent firms, you
Study Data Technical Conformance must add their gross receipts or sales to
Guide (the ‘‘Guide,’’ available at http:// AGENCY: Food and Drug Administration, yours, and the total must be no more
www.fda.gov/ForIndustry/ HHS. than $100 million. If your gross receipts
DataStandards/StudyDataStandards/ ACTION: Notice of availability. or sales are no more than $30 million,
default.htm), which contains technical including all of your affiliates, partners,
SUMMARY: The Food and Drug
recommendations to sponsors for the and parent firms, you will also qualify
Administration (FDA) is announcing
submission of animal and human study for a waiver of the fee for your first
that a proposed collection of
data and related information in a (ever) premarket application (product
information has been submitted to the
standardized electronic format. In development protocol, biologics
Office of Management and Budget
section 2.2 of the Guide, FDA licensing application, or premarket
jstallworth on DSK7TPTVN1PROD with NOTICES
(OMB) for review and clearance under
recommends that each submitted study report). An applicant must pay the full
the Paperwork Reduction Act of 1995.
contain a Study Data Reviewer’s Guide standard fee unless it provides evidence
containing any special considerations or DATES: Fax written comments on the demonstrating to FDA that it meets the
directions that may facilitate review of collection of information by April 4, small business criteria (Form FDA 3602,
the study data. FDA notes in the Guide 2016. ‘‘FY 2016 MDUFMA Small Business
that the PhUSE SDRG template is an ADDRESSES: To ensure that comments on Qualification Certification—For a
example of how to create an SDRG but the information collection are received, Business Headquartered in the United
VerDate Sep<11>2014 15:22 Mar 03, 2016 Jkt 238001 PO 00000 Frm 00069 Fmt 4703 Sfmt 4703 E:\FR\FM\04MRN1.SGM 04MRN1](https://thefederalregister.org/doc/81_FR_11619/page/1.svg)
![Federal Register / Vol. 81, No. 43 / Friday, March 4, 2016 / Notices 11577
States’’). The evidence required by qualifying for the small business fee groups/fdagov-public/@fdagov-meddev-
MDUFMA is a copy of the most recent rates. Thus, foreign governments, gen/documents/document/
Federal income tax return of the including the European Union, have ucm456779.pdf. This guidance
applicant, and any affiliate, partner, or objected. In lieu of a Federal income tax describes the criteria FDA will use to
parent firm. FDA will review these return, the 2007 Amendments will decide whether an entity qualifies as a
materials and decide whether an allow a foreign business to qualify as a MDUFMA small business and will help
applicant is a small business within the small business by submitting a prospective applicants understand what
meaning of MDUFMA. certification from its national taxing they need to do to meet the small
The 2007 Amendments provide an authority, the foreign equivalent of our business criteria for FY 2016.
alternative way for a foreign business to Internal Revenue Service. This The estimated burden is based on the
qualify as a small business eligible to certification, referred to as a ‘‘National number of applications received in the
pay a significantly lower fee when a Taxing Authority Certification,’’ must: last 3 years and includes time required
medical device user fee must be paid (1) Be in English; (2) be from the to collect the required information.
(Form FDA 3602A, ‘‘FY 2016 MDUFMA national taxing authority of the country Based on our experience with Form
Foreign Small Business Qualification in which the business is headquartered; FDA 3602, FDA believes it will take
Certification—For a Business (3) provide the business’ gross receipts each respondent 1 hour to complete the
Headquartered Outside the United or sales for the most recent year, in both form. Based on our experience with
States’’). Before passage of the 2007 the local currency and in U.S. dollars, Form FDA 3602A, FDA also believes
Amendments, the only way a business and the exchange rate used in that it will take each respondent 1 hour
could qualify as a small business was to converting local currency to U.S. to complete.
submit a Federal (U.S.) income tax dollars; (4) provide the dates during
return showing its gross receipts or sales which the reported receipts or sales In the Federal Register of September
that did not exceed a statutory were collected; and (5) bear the official 17, 2015 (80 FR 55854), FDA published
threshold, currently, $100 million. If a seal of the national taxing authority. a 60-day notice requesting public
business could not provide a Federal Both Forms FDA 3602 and FDA comment on the proposed collection of
income tax return, it did not qualify as 3602A are available in the guidance information. Although one comment
a small business and had to pay the document, ‘‘FY 2016 Medical Device was received, it was not responsive to
standard (full) fee. Because many User Fee Small Business Qualification the four collection of information topics
foreign businesses have not, and cannot, and Certification; Guidance for Industry, solicited and therefore will not be
file a Federal (U.S.) income tax return, Food and Drug Administration Staff, discussed in this document.
this requirement has effectively and Foreign Governments’’ available on FDA estimates the burden of this
prevented those businesses from the Internet at: http://www.fda.gov/ucm/ collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
FDA Form No. responses per burden per Total hours
respondents responses
respondent response
FDA 3602—FY 2016 MDUFA Small Business Qualification
and Certification For a Business Headquartered in the
United States .................................................................... 3,600 1 3,600 1 3,600
FDA 3602A—FY 2016 MDUFA Foreign Small Business
Qualification and Certification For a Business
Headquartered Outside the United States ....................... 1,400 1 1,400 1 1,400
Total .............................................................................. ........................ ........................ ........................ ........................ 5,000
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: February 29, 2016. DEPARTMENT OF HEALTH AND guidance entitled ‘‘Labeling for
Leslie Kux, HUMAN SERVICES Permanent Hysteroscopically-Placed
Associate Commissioner for Policy. Tubal Implants Intended for
Food and Drug Administration Sterilization.’’ This draft guidance
[FR Doc. 2016–04704 Filed 3–3–16; 8:45 am]
BILLING CODE 4164–01–P
addresses the inclusion of a boxed
[Docket No. FDA–2016–D–0435]
warning and a patient decision checklist
Labeling for Permanent in the product labeling for permanent
Hysteroscopically-Placed Tubal hysteroscopically-placed tubal implants
Implants Intended for Sterilization, intended for female sterilization and as
Draft Guidance for Industry and Food well as the content and format of those
and Drug Administration Staff; materials. This draft guidance is being
Availability issued in response to information
jstallworth on DSK7TPTVN1PROD with NOTICES
provided to FDA, including in
AGENCY: Food and Drug Administration, comments made at a 2015 Panel meeting
HHS.
and in comments submitted to the
ACTION: Notice of availability. associated public docket, that women
SUMMARY: The Food and Drug are not receiving or understanding
Administration (FDA or Agency) is information relating to the risks and
announcing the availability of the draft benefits of this type of device. This draft
VerDate Sep<11>2014 15:22 Mar 03, 2016 Jkt 238001 PO 00000 Frm 00070 Fmt 4703 Sfmt 4703 E:\FR\FM\04MRN1.SGM 04MRN1](https://thefederalregister.org/doc/81_FR_11619/page/2.svg)
Document Created: 2018-02-02 15:05:17
Document Modified: 2018-02-02 15:05:17
| 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 of availability. | |
| Dates | Fax written comments on the collection of information by April 4, 2016. | |
| Contact | FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected] | |
| FR Citation | 81 FR 11576 |
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