Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device User Fee and Modernization Act Small Business Qualification Certification (Form FDA 3602), 51196-51197 [E6-14267]

Download as PDF 51196 Federal Register / Vol. 71, No. 167 / Tuesday, August 29, 2006 / Notices Dated: August 22, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6–14266 Filed 8–28–06; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006N–0327] Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device User Fee and Modernization Act Small Business Qualification Certification (Form FDA 3602) AGENCY: Food and Drug Administration, HHS. Notice. ACTION: 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 the proposed collection of information that will permit an applicant to certify that it qualifies as a ‘‘small business’’ within the meaning of the Medical Device User Fee and Modernization Act (MDUFMA). DATES: Submit written or electronic comments on the collection of information by October 30, 2006. ADDRESSES: Submit electronic comments on the collection of information to: https://www.fda.gov/ dockets/ecomments. 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: Denver Presley, Jr., Office of Management Programs (HFA–250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–827– 1472. 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. MDUFMA Small Business Qualification Certification (Form FDA 3602)—(OMB Control Number 0910–0508)—Extension MDUFMA 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 2, 2006 (71 FR 43784), announcing fees for fiscal year (FY) 2007. 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. For FY 2006, 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 (PMA, product development protocol (PDP), biologics licensing application (BLA), 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. 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. Form FDA 3602 is available in guidance document, ‘‘Guidance for Industry and FDA: FY 2006 MDUFMA Small Business Qualification Worksheet and Certification.’’ 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 2006 and subsequent fiscal years. Description of Respondents: Respondents will be businesses or other for-profit organizations. FDA estimates the burden of this collection of information as follows: TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1 jlentini on PROD1PC65 with NOTICES FDA Form Number No. of Respondents 3602 Annual Frequency per Response 2,000 Total Annual Responses 1 Hours per Response 2,000 1 Total Hours 1There 2,000 2,000 are no capital costs or operating and maintenance costs associated with this collection of information. VerDate Aug<31>2005 Total Hours 17:07 Aug 28, 2006 Jkt 208001 PO 00000 Frm 00014 Fmt 4703 Sfmt 4703 E:\FR\FM\29AUN1.SGM 29AUN1 Federal Register / Vol. 71, No. 167 / Tuesday, August 29, 2006 / Notices The burden is based on the number of applications received in the last 3 years. Dated: August 18, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6–14267 Filed 8–28–06; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Allergenic Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. jlentini on PROD1PC65 with NOTICES ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). At least one portion of the meeting will be closed to the public. Name of Committee: Allergenic Products Advisory Committee. General Function of the Committee: To provide advice and recommendations to the agency on FDA’s regulatory issues. Date and Time: The meeting will be held on September 13, 2006 from 12 noon to approximately 3:45 p.m. Location: National Institutes of Health, Bldg. 29B, Conference Rooms A and B, Bethesda, MD. Contact Person: Gail Dapolito or Jane Brown, Center for Biologics Evaluation and Research (HFM–71), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852, 301–827–0314 or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the Washington, DC area), code 3014512388. Please call the Information Line for up-to-date information on this meeting. Agenda: On September 13, 2006, the committee will discuss a proposed strategy for the reclassification of Category IIIA allergenic products. The committee will also receive an update of the research program of the Laboratory of Immunobiochemistry, Division of Bacterial, Parasitic and Allergenic Products, Center for Biologics Evaluation and Research. Procedure: On September 13, 2006, from 12 noon to approximately 3:15 pm, the meeting is open to the public. Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before September 6, 2006. Oral presentations from the public will be scheduled VerDate Aug<31>2005 17:07 Aug 28, 2006 Jkt 208001 between approximately 1:45 pm and 2:45 pm. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before September 6, 2006. Closed Committee Deliberations: On September 13, 2006 from approximately 3:15 pm to 3:45 p.m., the meeting will be closed to permit discussion where disclosure would constitute a clearly unwarranted invasion of personal privacy (5 U.S.C. 552b(c)(6)). The committee will discuss individual research programs in the Office of Vaccines Research and Review. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Gail Dapolito at least 7 days in advance of the meeting. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: August 23, 2006. Randall W. Lutter, Associate Commissioner for Policy and Planning. [FR Doc. E6–14295 Filed 8–28–06; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Cardiovascular and Renal Drugs Advisory Committee; Amendment of Notice AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing an amendment to the notice of meeting of the Cardiovascular and Renal Drugs Advisory Committee. This meeting was originally announced in the Federal Register of August 1, 2006 (71 FR 43487). The amendment is being made to reflect changes in the Agenda portion of the document. The word ‘‘TRASYOL’’ should read ‘‘TRASYLOL’’. In the same paragraph, PO 00000 Frm 00015 Fmt 4703 Sfmt 4703 51197 the word ‘‘apportioning’’ should read ‘‘aprotinin’’. There are no other changes. FOR FURTHER INFORMATION CONTACT: Cathy Groupe, Center for Drug Evaluation and Research (HFD–21), Food and Drug Administration, 5600 Fishers Lane (for express delivery, 5630 Fishers Lane, rm. 1093) Rockville, MD 20857, 301–827–7001, FAX: 301–827– 6778, e-mail: Cathy.Groupe@fda.hhs.gov, or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the Washington, DC area), code 3014512533. Please call the information line for up-to-date information on this meeting. In the Federal Register of August 1, 2006, FDA announced that the Cardiovascular and Renal Drugs Advisory Committee would meet on September 21, 2006, from 8 a.m. to 5 p.m., and the committee would discuss clinical data for aprotinin injection (trade name, TRASYLOL), an approved product, new drug application (NDA) 020–304, Bayer Pharmaceuticals). On page 43487, in the third column, the Agenda portion of the document is amended to read as follows: Agenda: The committee will discuss clinical data for aprotinin injection (trade name, TRASYLOL), an approved product, new drug application (NDA) 020–304, Bayer Pharmaceuticals) with the indication for prophylactic use to reduce perioperative blood loss and the need for blood transfusion in patients undergoing cardiopulmonary bypass in the course of coronary artery bypass graft surgery. This discussion follows a February 8, 2006, FDA Public Health Advisory for the use of aprotinin injection (www.fda.gov/cder/drug/ advisory/aprotinin.htm). The background material for this meeting will be posted 1 business day before the meeting on FDA’s Web site at https://www.fda.gov/ohrms/dockets/ac/ acmenu.htm under the heading ‘‘Cardiovascular and Renal Drugs Advisory Committee’’ (Click on the year 2006 and scroll down to the above named committee meeting.) This notice is issued under the Federal Advisory Committee Act (5 U.S.C. app. 2) and 21 CFR part 14, relating to the advisory committees. SUPPLEMENTARY INFORMATION: Dated: August 23, 2006. Randall W. Lutter, Associate Commissioner for Policy and Planning. [FR Doc. E6–14294 Filed 8–28–06; 8:45 am] BILLING CODE 4160–01–S E:\FR\FM\29AUN1.SGM 29AUN1

Agencies

[Federal Register Volume 71, Number 167 (Tuesday, August 29, 2006)]
[Notices]
[Pages 51196-51197]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-14267]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006N-0327]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Medical Device User Fee and Modernization Act Small 
Business Qualification Certification (Form FDA 3602)

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 the proposed collection of 
information that will permit an applicant to certify that it qualifies 
as a ``small business'' within the meaning of the Medical Device User 
Fee and Modernization Act (MDUFMA).

DATES:  Submit written or electronic comments on the collection of 
information by October 30, 2006.

ADDRESSES:  Submit electronic comments on the collection of information 
to: https://www.fda.gov/dockets/ecomments. 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: Denver Presley, Jr., Office of 
Management Programs (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-1472.

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.

MDUFMA Small Business Qualification Certification (Form FDA 3602)--(OMB 
Control Number 0910-0508)--Extension

    MDUFMA 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 2, 2006 (71 FR 43784), announcing 
fees for fiscal year (FY) 2007. 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.
    For FY 2006, 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 (PMA, product development protocol 
(PDP), biologics licensing application (BLA), 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. 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.
    Form FDA 3602 is available in guidance document, ``Guidance for 
Industry and FDA: FY 2006 MDUFMA Small Business Qualification Worksheet 
and Certification.'' 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 2006 and subsequent fiscal 
years.
    Description of Respondents: Respondents will be businesses or other 
for-profit organizations.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                              No. of         Annual Frequency       Total Annual        Hours per
                    FDA Form Number                        Respondents         per Response          Responses           Response         Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
3602                                                                2,000                     1              2,000                  1              2,000
---------------------------------------------------------------------------------------------------------------------------------------
Total Hours                                             .................  ....................  .................  .................              2,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.


[[Page 51197]]

    The burden is based on the number of applications received in the 
last 3 years.

    Dated: August 18, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-14267 Filed 8-28-06; 8:45 am]
BILLING CODE 4160-01-S
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