80 FR 55854 - Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device User Fee Small Business Qualification and Certification
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 180 (September 17, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 180 (September 17, 2015)
| Page Range | 55854-55855 | |
| FR Document | 2015-23331 |
[Federal Register Volume 80, Number 180 (Thursday, September 17, 2015)] [Notices] [Pages 55854-55855] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-23331] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-N-3287] Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device User Fee Small Business Qualification and Certification AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on Form FDA 3602 and Form FDA 3602A, which will allow domestic and foreign applicants to certify that they qualify as a small business and pay certain medical device user fees at reduced rates. DATES: Submit either electronic or written comments on the collection of information by November 16, 2015. ADDRESSES: Submit electronic comments on the collection of information to http://www.regulations.gov. Submit written comments on the collection of information to the Division of Dockets Management (HFA- 305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. All comments should be identified with the 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: Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. ``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document. With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. 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 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 [[Page 55855]] 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: Be in English; be from the national taxing authority of the country in which the business is headquartered; 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; provide the dates during which the reported receipts or sales were collected; and 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. FDA estimates the burden of this collection of information as follows: Table 1--Estimated Annual Reporting Burden \1\ ---------------------------------------------------------------------------------------------------------------- Number of FDA form no. Number of responses per Total annual Average burden Total hours respondents respondent responses per 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: September 11, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-23331 Filed 9-16-15; 8:45 am] BILLING CODE 4164-01-P
![55854 Federal Register / Vol. 80, No. 180 / Thursday, September 17, 2015 / Notices
collection of information between 30 comments should be identified with the businesses, MDUFMA provides for
and 60 days after publication of this docket number found in brackets in the reduced or waived fees for applicants
document in the Federal Register. heading of this document. who qualify as a small business. This
Therefore, a comment is best assured of FOR FURTHER INFORMATION CONTACT: FDA means there are two levels of fees; a
having its full effect if OMB receives it PRA Staff, Office of Operations, Food standard fee and a reduced or waived
within 30 days of publication. Written and Drug Administration, 8455 small business fee. You can qualify for
comments and recommendations for the Colesville Rd., COLE–14526, Silver a small business fee discount under
proposed information collection should Spring, MD 20993–0002, PRAStaff@ MDUFMA if you reported gross receipts
be sent directly to the following: Office fda.hhs.gov. or sales of no more than $100 million
of Management and Budget, Paperwork on your Federal income tax return for
SUPPLEMENTARY INFORMATION: Under the
Reduction Project, Email: OIRA_ the most recent tax year. If you have any
PRA (44 U.S.C. 3501–3520), Federal
SUBMISSION@OMB.EOP.GOV, Attn: affiliates, partners, or parent firms, you
Agencies must obtain approval from the
Desk Officer for the Administration for must add their gross receipts or sales to
Office of Management and Budget
Children and Families. yours, and the total must be no more
(OMB) for each collection of
Robert Sargis, information they conduct or sponsor. than $100 million. If your gross receipts
‘‘Collection of information’’ is defined or sales are no more than $30 million,
ACF Reports Clearance Officer.
in 44 U.S.C. 3502(3) and 5 CFR including all of your affiliates, partners,
[FR Doc. 2015–23353 Filed 9–16–15; 8:45 am]
1320.3(c) and includes Agency requests and parent firms, you will also qualify
BILLING CODE 4184–07–P
or requirements that members of the for a waiver of the fee for your first
public submit reports, keep records, or (ever) premarket application (product
provide information to a third party. development protocol, biologics
DEPARTMENT OF HEALTH AND
Section 3506(c)(2)(A) of the PRA (44 licensing application, or premarket
HUMAN SERVICES
U.S.C. 3506(c)(2)(A)) requires Federal report). An applicant must pay the full
Food and Drug Administration Agencies to provide a 60-day notice in standard fee unless it provides evidence
the Federal Register concerning each demonstrating to FDA that it meets the
[Docket No. FDA–2015–N–3287] small business criteria (Form FDA 3602,
proposed collection of information,
including each proposed extension of an ‘‘FY 2016 MDUFMA Small Business
Agency Information Collection
existing collection of information, Qualification Certification—For a
Activities; Proposed Collection;
before submitting the collection to OMB Business Headquartered in the United
Comment Request; Medical Device
for approval. To comply with this States’’). The evidence required by
User Fee Small Business Qualification
requirement, FDA is publishing notice MDUFMA is a copy of the most recent
and Certification
of the proposed collection of Federal income tax return of the
AGENCY: Food and Drug Administration, information set forth in this document. applicant, and any affiliate, partner, or
HHS. With respect to the following parent firm. FDA will review these
ACTION: Notice. collection of information, FDA invites materials and decide whether an
comments on these topics: (1) Whether applicant is a small business within the
SUMMARY: The Food and Drug meaning of MDUFMA.
Administration (FDA) is announcing an the proposed collection of information
is necessary for the proper performance The 2007 Amendments provide an
opportunity for public comment on the alternative way for a foreign business to
proposed collection of certain of FDA’s functions, including whether
the information will have practical qualify as a small business eligible to
information by the Agency. Under the pay a significantly lower fee when a
Paperwork Reduction Act of 1995 (the utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed medical device user fee must be paid
PRA), Federal Agencies are required to (Form FDA 3602A, ‘‘FY 2016 MDUFMA
publish notice in the Federal Register collection of information, including the
validity of the methodology and Foreign Small Business Qualification
concerning each proposed collection of Certification—For a Business
information, including each proposed assumptions used; (3) ways to enhance
the quality, utility, and clarity of the Headquartered Outside the United
extension of an existing collection of States’’). Before passage of the 2007
information, and to allow 60 days for information to be collected; and (4)
ways to minimize the burden of the Amendments, the only way a business
public comment in response to the could qualify as a small business was to
notice. This notice solicits comments on collection of information on
respondents, including through the use submit a Federal (U.S.) income tax
Form FDA 3602 and Form FDA 3602A, return showing its gross receipts or sales
which will allow domestic and foreign of automated collection techniques,
when appropriate, and other forms of that did not exceed a statutory
applicants to certify that they qualify as threshold, currently, $100 million. If a
a small business and pay certain information technology.
business could not provide a Federal
medical device user fees at reduced Medical Device User Fee Small income tax return, it did not qualify as
rates. Business Qualification and a small business and had to pay the
DATES: Submit either electronic or Certification—OMB Control Number standard (full) fee. Because many
written comments on the collection of 0910–0508—Extension foreign businesses have not, and cannot,
information by November 16, 2015. Section 101 of the Medical Device file a Federal (U.S.) income tax return,
ADDRESSES: Submit electronic User Fee and Modernization Act this requirement has effectively
comments on the collection of (MDUFMA) (Pub. L. 107–250) amends prevented those businesses from
tkelley on DSK3SPTVN1PROD with NOTICES
information to http:// the Federal Food, Drug, and Cosmetic qualifying for the small business fee
www.regulations.gov. Submit written Act, to provide for user fees for certain rates. Thus, foreign governments,
comments on the collection of medical device applications. FDA including the European Union, have
information to the Division of Dockets published a Federal Register notice on objected. In lieu of a Federal income tax
Management (HFA–305), Food and Drug August 3, 2015 (80 FR 46033), return, the 2007 Amendments will
Administration, 5630 Fishers Lane, Rm. announcing fees for fiscal year (FY) allow a foreign business to qualify as a
1061, Rockville, MD 20852. All 2016. To avoid harming small small business by submitting a
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![Federal Register / Vol. 80, No. 180 / Thursday, September 17, 2015 / Notices 55855
certification from its national taxing official seal of the national taxing prospective applicants understand what
authority, the foreign equivalent of our authority. they need to do to meet the small
Internal Revenue Service. This Both Forms FDA 3602 and FDA business criteria for FY 2016.
certification, referred to as a ‘‘National 3602A are available in the guidance The estimated burden is based on the
Taxing Authority Certification’’, must: document, ‘‘FY 2016 Medical Device number of applications received in the
Be in English; be from the national User Fee Small Business Qualification last 3 years and includes time required
taxing authority of the country in which and Certification; Guidance for Industry, to collect the required information.
the business is headquartered; provide Food and Drug Administration Staff, Based on our experience with Form
the business’ gross receipts or sales for and Foreign Governments’’ available on FDA 3602, FDA believes it will take
the most recent year, in both the local the Internet at: http://www.fda.gov/ucm/ each respondent 1 hour to complete the
currency and in U.S. dollars, and the groups/fdagov-public/@fdagov-meddev- form. Based on our experience with
exchange rate used in converting local gen/documents/document/ Form FDA 3602A, FDA also believes
ucm456779.pdf. This guidance that it will take each respondent 1 hour
currency to U.S. dollars; provide the
describes the criteria FDA will use to to complete.
dates during which the reported receipts
decide whether an entity qualifies as a FDA estimates the burden of this
or sales were collected; and bear the MDUFMA small business and will help collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average bur-
Number of Total annual
FDA form no. responses per den per re- Total hours
respondents responses
respondent sponse
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: September 11, 2015. public comment in response to the information they conduct or sponsor.
Leslie Kux, notice. This notice solicits comments on ‘‘Collection of information’’ is defined
Associate Commissioner for Policy. FDA’s meetings with tobacco in 44 U.S.C. 3502(3) and 5 CFR
[FR Doc. 2015–23331 Filed 9–16–15; 8:45 am] manufacturers, importers, researchers, 1320.3(c) and includes Agency requests
BILLING CODE 4164–01–P
and/or investigators relating to their or requirements that members of the
plans to conduct research to inform the public submit reports, keep records, or
regulation of tobacco products, or provide information to a third party.
DEPARTMENT OF HEALTH AND support the development or marketing Section 3506(c)(2)(A) of the PRA (44
HUMAN SERVICES of tobacco products. U.S.C. 3506(c)(2)(A)) requires Federal
DATES: Submit either electronic or Agencies to provide a 60-day notice in
Food and Drug Administration written comments on the collection of the Federal Register concerning each
information by November 16, 2015. proposed collection of information,
[Docket No. FDA–2012–D–0429]
ADDRESSES: Submit electronic
including each proposed extension of an
Agency Information Collection comments on the collection of existing collection of information,
Activities; Proposed Collection; information to http:// before submitting the collection to OMB
Comment Request; Guidance on www.regulations.gov. Submit written for approval. To comply with this
Meetings With Industry and comments on the collection of requirement, FDA is publishing notice
Investigators on the Research and information to the Division of Dockets of the proposed collection of
Development of Tobacco Products Management (HFA–305), Food and Drug information set forth in this document.
With respect to the following
Administration, 5630 Fishers Lane, Rm.
AGENCY: Food and Drug Administration, collection of information, FDA invites
1061, Rockville, MD 20852. All
HHS. comments on these topics: (1) Whether
comments should be identified with the
ACTION: Notice. the proposed collection of information
docket number found in brackets in the
is necessary for the proper performance
heading of this document.
SUMMARY: The Food and Drug of FDA’s functions, including whether
Administration (FDA) is announcing an FOR FURTHER INFORMATION CONTACT: FDA the information will have practical
opportunity for public comment on the PRA Staff, Office of Operations, Food utility; (2) the accuracy of FDA’s
proposed collection of certain and Drug Administration, 8455 estimate of the burden of the proposed
information by the Agency. Under the Colesville Rd., COLE–14526, Silver collection of information, including the
Spring, MD 20993–0002, PRAStaff@
tkelley on DSK3SPTVN1PROD with NOTICES
Paperwork Reduction Act of 1995 (the validity of the methodology and
PRA), Federal Agencies are required to fda.hhs.gov. assumptions used; (3) ways to enhance
publish notice in the Federal Register SUPPLEMENTARY INFORMATION: Under the the quality, utility, and clarity of the
concerning each proposed collection of PRA (44 U.S.C. 3501–3520), Federal information to be collected; and (4)
information, including each proposed Agencies must obtain approval from the ways to minimize the burden of the
extension of an existing collection of Office of Management and Budget collection of information on
information, and to allow 60 days for (OMB) for each collection of respondents, including through the use
VerDate Sep<11>2014 17:30 Sep 16, 2015 Jkt 235001 PO 00000 Frm 00030 Fmt 4703 Sfmt 4703 E:\FR\FM\17SEN1.SGM 17SEN1](https://thefederalregister.org/doc/80_FR_56034/page/2.svg)
Document Created: 2015-12-15 09:34:11
Document Modified: 2015-12-15 09:34:11
| 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 the collection of information by November 16, 2015. | |
| 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 | 80 FR 55854 |
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