83 FR 56852 - 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 83, Issue 220 (November 14, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 220 (November 14, 2018)
| Page Range | 56852-56854 | |
| FR Document | 2018-24790 |
[Federal Register Volume 83, Number 220 (Wednesday, November 14, 2018)] [Notices] [Pages 56852-56854] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-24790] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-N-4206] 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 or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (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 January 14, 2019. ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before January 14, 2019. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of January 14, 2019. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ``Written/Paper Submissions'' and ``Instructions''). Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ``Instructions.'' Instructions: All submissions received must include the Docket No. FDA-2018-N-4206 for ``Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device User Fee Small Business Qualification and Certification.'' Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday. Confidential Submissions--To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ``confidential.'' Any information marked as ``confidential'' will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the [[Page 56853]] docket number, found in brackets in the heading of this document, into the ``Search'' box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-8867, [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 Medical device user fees were first established in 2002 by the Medical Device User Fee and Modernization Act (MDUFMA) (Pub. L. 107- 250). User fees were renewed in 2007, with the Medical Device User Fee Amendments to the FDA Amendments Act (MDUFA II), in 2012 with the Medical Device User Fee Amendments to the FDA Safety and Innovation Act (MDUFA III), and in 2017 with the Medical Device User Fee Amendments to the FDA Reauthorization Act (MDUFA IV). MDUFA IV will be in place from October 1, 2017, until September 30, 2022. A business that is qualified and certified as a ``small business'' is eligible for a substantial reduction in most of these user fees. The guidance document entitled ``Medical Device User Fee Small Business Qualification and Certification Guidance for Industry, Food and Drug Administration Staff and Foreign Governments'' describes the criteria FDA will use to decide whether an entity is eligible for a reduction in user fees and the process by which a business may request certification as a small business. An applicant can qualify for a small business fee discount under MDUFMA if they reported gross receipts or sales of no more than $100 million on their Federal income tax return for the most recent tax year. If they have any affiliates, partners, or parent firms, the applicant must add the gross receipts or sales of the affiliates, partners, or parent firms to the applicant's, and the total must be no more than $100 million. If the applicant's gross receipts or sales are no more than $30 million, including all of their affiliates, partners, and parent firms, they will also qualify for a waiver of the fee for their 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, ``MDUFA Small Business Certification Request 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. MDUFA II provided 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, ``MDUFA Foreign Small Business Certification Request for a Business Headquartered Outside the United States''). Before passage of MDUFA II, 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 effectively prevented those businesses from qualifying for the small business fee rates. Thus, foreign governments, including the European Union, objected. In lieu of a Federal income tax return, the MDUFA II allowed 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. Forms FDA 3602 and FDA 3602A are available in the guidance document entitled ``Medical Device User Fee Small Business Qualification and Certification Guidance for Industry, Food and Drug Administration Staff and Foreign Governments'' on the internet at: https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-gen/documents/document/ucm456779.pdf. 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: [[Page 56854]] 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--MDUFA Small Business 5,000 1 5,000 1 5,000 Certification Request For a Business Headquartered in the United States.................. FDA 3602A--MDUFA Foreign Small 2,000 1 2,000 1 2,000 Business Certification Request For a Business Headquartered Outside the United States...... ------------------------------------------------------------------------------- Total....................... .............. .............. .............. .............. 7,000 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. Our estimated burden for the information collection reflects an overall increase of 2,000 hours and a corresponding increase of 2,000 responses. We attribute this adjustment to an increase in the number of submissions we received over the last few years. Dated: November 7, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-24790 Filed 11-13-18; 8:45 am] BILLING CODE 4164-01-P
![56852 Federal Register / Vol. 83, No. 220 / Wednesday, November 14, 2018 / Notices
et al., ‘‘Prescribers’ Knowledge and Skills 1995 (PRA), Federal Agencies are • Mail/Hand delivery/Courier (for
for Interpreting Research Results: A required to publish notice in the written/paper submissions): Dockets
Systematic Review,’’ Journal of Federal Register concerning each Management Staff (HFA–305), Food and
Continuing Education in the Health Drug Administration, 5630 Fishers
proposed collection of information,
Professions, 37(2):129–136, 2017.
* 15. Tversky, A. and D. Kahneman,’’ including each proposed extension of an Lane, Rm. 1061, Rockville, MD 20852.
Judgment Under Uncertainty: Heuristics existing collection of information, and • For written/paper comments
and Biases,’’ Science, 185(4157):1124– to allow 60 days for public comment in submitted to the Dockets Management
1131, 1974. response to the notice. This notice Staff, FDA will post your comment, as
* 16. Gehlbach, H. and S. Barge, ‘‘Anchoring solicits comments on Form FDA 3602 well as any attachments, except for
and Adjusting in Questionnaire and Form FDA 3602A, which will allow information submitted, marked and
Responses,’’ Basic and Applied Social domestic and foreign applicants to identified, as confidential, if submitted
Psychology, 34(5):417–433, 2012. as detailed in ‘‘Instructions.’’
certify that they qualify as a small
* 17. Epley, N. and T. Gilovich, ‘‘The Instructions: All submissions received
Anchoring-and-Adjustment Heuristic: business and pay certain medical device
user fees at reduced rates. must include the Docket No. FDA–
Why the Adjustments are Insufficient,’’
2018–N–4206 for ‘‘Agency Information
Psychological Science, 17(4):311–318, DATES: Submit either electronic or
2006. Collection Activities; Proposed
written comments on the collection of
* 18. Höhne, J.K. and D. Krebs, ‘‘Scale Collection; Comment Request; Medical
information by January 14, 2019.
Direction Effects in Agree/Disagree and Device User Fee Small Business
Item-Specific Questions: A Comparison ADDRESSES: You may submit comments Qualification and Certification.’’
of Question Formats,’’ International as follows. Please note that late, Received comments, those filed in a
Journal of Social Research Methodology, untimely filed comments will not be timely manner (see ADDRESSES), will be
21(1):91–103, 2017. considered. Electronic comments must placed in the docket and, except for
* 19. Saris, W.E., M. Revilla, J.A. Krosnick, et be submitted on or before January 14, those submitted as ‘‘Confidential
al., ‘‘Comparing Questions with Agree/ 2019. The https://www.regulations.gov
Disagree Response Options to Questions Submissions,’’ publicly viewable at
electronic filing system will accept https://www.regulations.gov or at the
with Item-Specific Response Options’’
Survey Research Methods, 4:61–79,
comments until 11:59 p.m. Eastern Time Dockets Management Staff between 9
2010. at the end of January 14, 2019. a.m. and 4 p.m., Monday through
* 20. Krosnick, J.A. and S. Presser, ‘‘Question Comments received by mail/hand Friday.
and Questionnaire Design,’’ In: delivery/courier (for written/paper • Confidential Submissions—To
Handbook of Survey Research (pp. 263– submissions) will be considered timely submit a comment with confidential
314). Bingley, United Kingdom: Emerald if they are postmarked or the delivery information that you do not wish to be
Group Publishing Limited, 2010. service acceptance receipt is on or made publicly available, submit your
21. Converse, J.M. and S. Presser, Survey before that date. comments only as a written/paper
Questions: Handcrafting the
Electronic Submissions submission. You should submit two
Standardized Questionnaire, (No. 63).
Thousand Oaks, CA: SAGE Publications, copies total. One copy will include the
1986.
Submit electronic comments in the information you claim to be confidential
22. DeVellis, R.F., Scale Development: following way: with a heading or cover note that states
Theory and Applications, (Vol. 26). • Federal eRulemaking Portal: ‘‘THIS DOCUMENT CONTAINS
Thousand Oaks, CA: SAGE Publications, https://www.regulations.gov. Follow the CONFIDENTIAL INFORMATION.’’ The
2016. instructions for submitting comments. Agency will review this copy, including
Dated: November 7, 2018. Comments submitted electronically, the claimed confidential information, in
Leslie Kux,
including attachments, to https:// its consideration of comments. The
www.regulations.gov will be posted to second copy, which will have the
Associate Commissioner for Policy.
the docket unchanged. Because your claimed confidential information
[FR Doc. 2018–24785 Filed 11–13–18; 8:45 am]
comment will be made public, you are redacted/blacked out, will be available
BILLING CODE 4164–01–P solely responsible for ensuring that your for public viewing and posted on
comment does not include any https://www.regulations.gov. Submit
confidential information that you or a both copies to the Dockets Management
DEPARTMENT OF HEALTH AND third party may not wish to be posted, Staff. If you do not wish your name and
HUMAN SERVICES such as medical information, your or contact information to be made publicly
Food and Drug Administration anyone else’s Social Security number, or available, you can provide this
confidential business information, such information on the cover sheet and not
[Docket No. FDA–2018–N–4206] as a manufacturing process. Please note in the body of your comments and you
that if you include your name, contact must identify this information as
Agency Information Collection information, or other information that ‘‘confidential.’’ Any information marked
Activities; Proposed Collection; identifies you in the body of your as ‘‘confidential’’ will not be disclosed
Comment Request; Medical Device comments, that information will be except in accordance with 21 CFR 10.20
User Fee Small Business Qualification posted on https://www.regulations.gov. and other applicable disclosure law. For
and Certification • If you want to submit a comment more information about FDA’s posting
AGENCY: Food and Drug Administration, with confidential information that you of comments to public dockets, see 80
HHS. do not wish to be made available to the FR 56469, September 18, 2015, or access
ACTION: Notice. public, submit the comment as a the information at: https://www.gpo.gov/
written/paper submission and in the fdsys/pkg/FR-2015-09-18/pdf/2015-
SUMMARY: The Food and Drug manner detailed (see ‘‘Written/Paper 23389.pdf.
Administration (FDA or Agency) is Submissions’’ and ‘‘Instructions’’). Docket: For access to the docket to
announcing an opportunity for public read background documents or the
comment on the proposed collection of Written/Paper Submissions electronic and written/paper comments
certain information by the Agency. Submit written/paper submissions as received, go to https://
Under the Paperwork Reduction Act of follows: www.regulations.gov and insert the
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![56854 Federal Register / Vol. 83, No. 220 / Wednesday, November 14, 2018 / Notices
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—MDUFA Small Business Certification Request
For a Business Headquartered in the United States ....... 5,000 1 5,000 1 5,000
FDA 3602A—MDUFA Foreign Small Business Certification
Request For a Business Headquartered Outside the
United States .................................................................... 2,000 1 2,000 1 2,000
Total .............................................................................. ........................ ........................ ........................ ........................ 7,000
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Our estimated burden for the recommendations that will facilitate the Written/Paper Submissions
information collection reflects an universal acceptance of the generated Submit written/paper submissions as
overall increase of 2,000 hours and a residue depletion data to fulfill the follows:
corresponding increase of 2,000 national/regional requirements in order • Mail/Hand delivery/Courier (for
responses. We attribute this adjustment to establish appropriate Maximum written/paper submissions): Dockets
to an increase in the number of Residue Limits (MRLs) or other safe Management Staff (HFA–305), Food and
submissions we received over the last limits in honey following the treatment Drug Administration, 5630 Fishers
few years. of honeybees with veterinary drug Lane, Rm. 1061, Rockville, MD 20852.
Dated: November 7, 2018. products, or to justify withdrawal • For written/paper comments
Leslie Kux, periods in honey for registration or submitted to the Dockets Management
Associate Commissioner for Policy.
approval purposes, as applicable, when Staff, FDA will post your comment, as
an MRL already exists. well as any attachments, except for
[FR Doc. 2018–24790 Filed 11–13–18; 8:45 am]
BILLING CODE 4164–01–P DATES: The announcement of the information submitted, marked and
guidance is published in the Federal identified, as confidential, if submitted
Register on November 14, 2018. as detailed in ‘‘Instructions.’’
DEPARTMENT OF HEALTH AND Instructions: All submissions received
HUMAN SERVICES ADDRESSES: You may submit either must include the Docket No. FDA–
electronic or written comments on 2016–D–4461 for ‘‘Studies to Evaluate
Food and Drug Administration Agency guidances at any time as the Metabolism and Residue Kinetics of
follows: Veterinary Drugs in Food-Producing
[Docket No. FDA–2016–D–4461] Species: Study Design
Electronic Submissions
Recommendations for Residue Studies
International Cooperation on
Submit electronic comments in the in Honey for Establishing MRLs and
Harmonisation of Technical
following way: Withdrawal Periods’’ (VICH GL56).
Requirements for Registration of
Received comments will be placed in
Veterinary Medicinal Products; Study • Federal eRulemaking Portal:
the docket and, except for those
Design Recommendations for Residue https://www.regulations.gov. Follow the
submitted as ‘‘Confidential
Studies in Honey for Establishing instructions for submitting comments.
Submissions,’’ publicly viewable at
Maximum Residue Levels and Comments submitted electronically,
https://www.regulations.gov or at the
Withdrawal Periods; Guidance for including attachments, to https://
Dockets Management Staff between 9
Industry; Availability www.regulations.gov will be posted to a.m. and 4 p.m., Monday through
the docket unchanged. Because your Friday.
AGENCY: Food and Drug Administration,
comment will be made public, you are • Confidential Submissions—To
HHS.
solely responsible for ensuring that your submit a comment with confidential
ACTION: Notice of availability. comment does not include any information that you do not wish to be
SUMMARY: The Food and Drug confidential information that you or a made publicly available, submit your
Administration (FDA or Agency) is third party may not wish to be posted, comments only as a written/paper
announcing the availability of a final such as medical information, your or submission. You should submit two
guidance for industry (GFI) #243 anyone else’s Social Security number, or copies total. One copy will include the
entitled ‘‘Studies to Evaluate the confidential business information, such information you claim to be confidential
Metabolism and Residue Kinetics of as a manufacturing process. Please note with a heading or cover note that states
Veterinary Drugs in Food-Producing that if you include your name, contact ‘‘THIS DOCUMENT CONTAINS
Species: Study Design information, or other information that CONFIDENTIAL INFORMATION.’’ The
Recommendations for Residue Studies identifies you in the body of your Agency will review this copy, including
in Honey for Establishing MRLs and comments, that information will be the claimed confidential information, in
Withdrawal Periods’’ (VICH GL56). This posted on https://www.regulations.gov. its consideration of comments. The
guidance has been developed for • If you want to submit a comment second copy, which will have the
veterinary use by the International with confidential information that you claimed confidential information
Cooperation on Harmonisation of do not wish to be made available to the redacted/blacked out, will be available
Technical Requirements for Registration public, submit the comment as a for public viewing and posted on
of Veterinary Medicinal Products written/paper submission and in the https://www.regulations.gov. Submit
(VICH). This VICH guidance document manner detailed (see ‘‘Written/Paper both copies to the Dockets Management
is intended to provide study design Submissions’’ and ‘‘Instructions’’). Staff. If you do not wish your name and
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Document Created: 2018-11-14 03:31:33
Document Modified: 2018-11-14 03:31:33
| 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 January 14, 2019. | |
| Contact | Amber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-8867, [email protected] | |
| FR Citation | 83 FR 56852 |
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