Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry, FDA Staff, and Foreign Governments: Fiscal Year 2012 Medical Device User Fee Small Business Qualification and Certification, 6822-6823 [2013-02093]

Download as PDF 6822 Federal Register / Vol. 78, No. 21 / Thursday, January 31, 2013 / Notices Dated: January 25, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–02092 Filed 1–30–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2012–N–0324] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry, FDA Staff, and Foreign Governments: Fiscal Year 2012 Medical Device User Fee Small Business Qualification and Certification AGENCY: Food and Drug Administration, HHS. ACTION: Notice. 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. SUMMARY: Fax written comments on the collection of information by March 4, 2013. DATES: 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 oira_submission@omb.eop.gov. All comments should be identified with the OMB control number 0910–0508. Also include the FDA docket number found in brackets in the heading of this document. ADDRESSES: FOR FURTHER INFORMATION CONTACT: srobinson on DSK4SPTVN1PROD with Daniel Gittleson, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50– 400B, Rockville, MD 20850, 301–796– 5156, Daniel.Gittleson@fda.hhs.gov. In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. SUPPLEMENTARY INFORMATION: VerDate Mar<15>2010 17:38 Jan 30, 2013 Jkt 229001 Guidance for Industry, FDA Staff, and Foreign Governments: Fiscal Year 2012 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 (the FD&C Act) to provide for user fees for certain medical device applications. FDA published a Federal Register notice on August 1, 2011 (76 FR 45826), announcing fees for fiscal year (FY) 2012. 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 2012 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 2012 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 PO 00000 Frm 00020 Fmt 4703 Sfmt 4703 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: 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, ‘‘Guidance for Industry, Food and Drug Administration Staff, and Foreign Governments: FY 2012 Medical Device User Fee Small Business Qualification and Certification,’’ available on the Internet at: https://www. fda.gov/downloads/MedicalDevices/ DeviceRegulationandGuidance/ Overview/MedicalDeviceUserFeeand ModernizationActMDUFMA/ UCM267051.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 2012. The Form FDA 3602 burden is based on the number of applications received in the last 3 years. FDA believes most entities that submit Form FDA 3602A will not have any affiliates, and very few will have more than three or four affiliates. Based on our experience with Form FDA 3602A, FDA believes each business will require 1 hour to complete the form. In the Federal Register of April 18, 2012 (77 FR 23267), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received. E:\FR\FM\31JAN1.SGM 31JAN1 6823 Federal Register / Vol. 78, No. 21 / Thursday, January 31, 2013 / Notices FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of respondents Form FDA No. Number of responses per respondent Total annual responses Average burden per response Total hours 3602 ..................................................................................... 3602A ................................................................................... 4,200 900 1 1 4,200 900 1 1 4,200 900 Total .............................................................................. ........................ ........................ ........................ ........................ 5,100 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: January 25, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–02093 Filed 1–30–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2012–P–0916] Determination That DIFFERIN (Adapalene) Solution, 0.1%, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) has determined that DIFFERIN (adapalene) solution, 0.1% (NDA 20–338), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for adapalene solution, 0.1%, if all other legal and regulatory requirements are met. SUMMARY: srobinson on DSK4SPTVN1PROD with FOR FURTHER INFORMATION CONTACT: Nisha Shah, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 6222, Silver Spring, MD 20993–0002, 301–796–4455. SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98–417) (the 1984 amendments), which authorized the approval of duplicate versions of drug products approved under an ANDA procedure. ANDA applicants must, with certain exceptions, show that the drug for which they are seeking approval contains the same active ingredient in the same strength and dosage form as the ‘‘listed drug,’’ which is a version of VerDate Mar<15>2010 17:38 Jan 30, 2013 Jkt 229001 the drug that was previously approved. ANDA applicants do not have to repeat the extensive clinical testing otherwise necessary to gain approval of a new drug application (NDA). The only clinical data required in an ANDA are data to show that the drug that is the subject of the ANDA is bioequivalent to the listed drug. The 1984 amendments include what is now section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which requires FDA to publish a list of all approved drugs. FDA publishes this list as part of the ‘‘Approved Drug Products With Therapeutic Equivalence Evaluations,’’ which is known generally as the ‘‘Orange Book.’’ Under FDA regulations, drugs are removed from the list if the Agency withdraws or suspends approval of the drug’s NDA or ANDA for reasons of safety or effectiveness or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162). Under § 314.161(a)(1) (21 CFR 314.161(a)(1)), the Agency must determine whether a listed drug was withdrawn from sale for reasons of safety or effectiveness before an ANDA that refers to that listed drug may be approved. FDA may not approve an ANDA that does not refer to a listed drug. DIFFERIN (adapalene) solution, 0.1%, is the subject of NDA 20–338, held by Galderma Laboratories, L.P., and initially approved on May 31, 1996, and is indicated for the topical treatment of acne vulgaris. This product is currently listed in the ‘‘Discontinued Drug Product List’’ section of the Orange Book. Ei, Inc., on behalf of Call, Inc. (d/b/a Rochester Pharmaceuticals), submitted a citizen petition dated August 23, 2012 (Docket No. FDA–2012–P–0916), under 21 CFR 10.30, requesting that the Agency determine whether DIFFERIN (adapalene) solution, 0.1%, was withdrawn from sale for reasons of safety or effectiveness. PO 00000 Frm 00021 Fmt 4703 Sfmt 9990 After considering the citizen petition and reviewing Agency records, FDA has determined under § 314.161 that DIFFERIN (adapalene) solution, 0.1%, was not withdrawn for reasons of safety or effectiveness. The petitioner has identified no data or other information suggesting that this product was withdrawn for reasons of safety or effectiveness. We have carefully reviewed our files for records concerning the withdrawal of DIFFERIN (adapalene) solution, 0.1%, from sale. We also have independently evaluated relevant literature and data for possible postmarketing adverse events and have found no information that would indicate that this product was withdrawn from sale for reasons of safety or effectiveness. Accordingly, the Agency will continue to list DIFFERIN (adapalene) solution, 0.1%, in the ‘‘Discontinued Drug Product List’’ section of the Orange Book. The ‘‘Discontinued Drug Product List’’ delineates, among other items, drug products that have been discontinued from marketing for reasons other than safety or effectiveness. ANDAs that refer to DIFFERIN (adapalene) solution, 0.1%, may be approved by the Agency as long as they meet all other legal and regulatory requirements for the approval of ANDAs. If FDA determines that labeling for this drug product should be revised to meet current standards, the Agency will advise ANDA applicants to submit such labeling. Dated: January 24, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–02087 Filed 1–30–13; 8:45 am] BILLING CODE 4160–01–P E:\FR\FM\31JAN1.SGM 31JAN1

Agencies

[Federal Register Volume 78, Number 21 (Thursday, January 31, 2013)]
[Notices]
[Pages 6822-6823]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-02093]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0324]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Guidance for
Industry, FDA Staff, and Foreign Governments: Fiscal Year 2012 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 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 March
4, 2013.

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 oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-0508.
Also include the FDA docket number found in brackets in the heading of
this document.

FOR FURTHER INFORMATION CONTACT: Daniel Gittleson, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 301-796-5156,
Daniel.Gittleson@fda.hhs.gov.

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.

Guidance for Industry, FDA Staff, and Foreign Governments: Fiscal Year
2012 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 (the FD&C Act) to provide for user fees for certain medical device
applications. FDA published a Federal Register notice on August 1, 2011
(76 FR 45826), announcing fees for fiscal year (FY) 2012. 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 2012
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 2012 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: 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, ``Guidance for Industry, Food and Drug Administration Staff,
and Foreign Governments: FY 2012 Medical Device User Fee Small Business
Qualification and Certification,'' available on the Internet at: https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/Overview/MedicalDeviceUserFeeandModernizationActMDUFMA/UCM267051.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 2012.
The Form FDA 3602 burden is based on the number of applications
received in the last 3 years. FDA believes most entities that submit
Form FDA 3602A will not have any affiliates, and very few will have
more than three or four affiliates. Based on our experience with Form
FDA 3602A, FDA believes each business will require 1 hour to complete
the form.
In the Federal Register of April 18, 2012 (77 FR 23267), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.

[[Page 6823]]

FDA estimates the burden of this collection of information as
follows:

Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average
Form FDA No. Number of responses per Total annual burden per Total hours
respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
3602............................ 4,200 1 4,200 1 4,200
3602A........................... 900 1 900 1 900
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 5,100
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.

Dated: January 25, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-02093 Filed 1-30-13; 8:45 am]
BILLING CODE 4160-01-P

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