Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices: The Pre-Submission Program and Meetings With FDA Staff; Availability, 41413-41415 [2012-17078]

Download as PDF Federal Register / Vol. 77, No. 135 / Friday, July 13, 2012 / Notices (chloramphenicol) Capsules, 250 mg, may cause a number of adverse reactions, the most serious being bone marrow depression (anemia, thrombocytopenia, and granulocytopenia temporally associated with treatment). A boxed warning in the prescribing information for both chloramphenicol sodium succinate injection and chloramphenicol capsules states that serious hypoplastic anemia, thrombocytopenia, and granulocytopenia are known to occur after administration of chloramphenicol. The drug product labeling recommends extensive safety monitoring, including baseline blood studies followed by periodic blood studies approximately every 2 days during therapy. The boxed warning also describes fatal aplastic anemia associated with administration of the drug and aplastic anemia attributed to chloramphenicol that later terminated in leukemia. There is published literature which suggests that the risk of fatal aplastic anemia associated with the oral formulation of chloramphenicol may be higher than the risk associated with the intravenous formation. FDA has also reviewed the latest approved labeling for the product and has determined that this labeling is inadequate and a Risk Evaluation and Mitigation Strategy (REMS) would be required to ensure that the benefits of the drug outweigh its risks. The REMS may include Elements to Assure Safe Use, including restricted distribution, and a Medication Guide could be required as part of the labeling. FDA has determined that additional nonclinical and possibly clinical studies of safety and efficacy would be necessary before CHLOROMYCETIN (chloramphenicol) Capsules, 250 mg, could be considered for reintroduction to the market. Accordingly, the Agency will remove CHLOROMYCETIN (chloramphenicol) Capsules, 250 mg, from the list of drug products published in the Orange Book. FDA will not accept or approve ANDAs that refer to this drug product. srobinson on DSK4SPTVN1PROD with NOTICES Dated: July 10, 2012. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2012–17091 Filed 7–12–12; 8:45 am] BILLING CODE 4160–01–P VerDate Mar<15>2010 17:08 Jul 12, 2012 Jkt 226001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2012–D–0530] Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices: The Pre-Submission Program and Meetings With FDA Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ‘‘Medical Devices: The PreSubmission Program and Meetings with FDA Staff.’’ The purpose of this guidance is to describe the PreSubmission program (formerly the preInvestigational Device Exemption (IDE) program) for medical devices reviewed in the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER). In addition, the guidance provides recommendations regarding information that should be included in a Pre-Submission Package. This guidance also describes the procedures that CDRH and CBER intend to follow when industry representatives or application sponsors request a meeting with review staff. This draft guidance is not final nor is it in effect at this time. DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment of this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by October 11, 2012. Submit either written or electronic comments on this collection of information by September 11, 2012. ADDRESSES: Submit written requests for single copies of the draft guidance document entitled ‘‘Medical Devices: The Pre-Submission Program and Meetings with FDA Staff’’ to the Division of Small Manufacturers, International and Consumer Assistance, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4613, Silver Spring, MD 20993– 0002; or Office of Communication, Outreach and Development (HFM–40), Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 1401 Rockville Pike, Suite 200N, Rockville, MD 20852–1448. SUMMARY: PO 00000 Frm 00064 Fmt 4703 Sfmt 4703 41413 Send one self-addressed adhesive label to assist that office in processing your request, or fax your request to 301–847– 8149. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. Submit electronic comments on the draft guidance to https:// www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Identify comments with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Angela Krueger, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1666, Silver Spring, MD 20993–0002, 301– 796–6380; or Stephen Ripley, Center for Biologics Evaluation and Research (HFM–17), Food and Drug Administration, 1401 Rockville Pike, Suite 200N, Rockville, MD 20852–1448, 301–827–6210. SUPPLEMENTARY INFORMATION: I. Background Since its establishment in 1995, the pre-IDE program has been a successful resource for both medical device applicants and the FDA. Originally, this program was designed to provide applicants a mechanism to obtain FDA feedback on future IDE applications prior to their submission. Over time, the pre-IDE program evolved to include feedback on other device submission program areas, such as Premarket Approval (PMA) applications, Humanitarian Device Exemption (HDE) applications, and Premarket Notification (510(k)) Submissions, as well as to address questions related to whether a clinical study requires submission of an IDE. The purpose of this guidance is to update the pre-IDE program to reflect this broader scope and make important modifications to reflect changes in the premarket program areas as a result of the Food and Drug Administration Amendments Act of 2007 (FDAAA) (Pub. L. 110–85). This guidance also broadens the scope of the program to include those devices regulated by CBER. Accordingly, FDA is changing the name for this program from the preIDE program to the Pre-Submission (PreSub) program. The main purpose of the Pre-Sub program remains the same as the preIDE program: to facilitate providing advice to applicants when they have specific questions during product development and early protocol E:\FR\FM\13JYN1.SGM 13JYN1 srobinson on DSK4SPTVN1PROD with NOTICES 41414 Federal Register / Vol. 77, No. 135 / Friday, July 13, 2012 / Notices planning, about device studies that present significant risk(s) (SR) as well as non-significant risk(s) (NSR) or when developing protocols for clinical studies conducted outside of the United States to support future U.S. marketing applications (Ref. 1). Consequently, the Pre-Sub program can provide an efficient path from device concept to market while facilitating the Agency’s goal of meeting FDAAA and Medical Device User Fee Act of 2008 (MDUFA II) review milestones. The Pre-Sub program has also faced several challenges, and the guidance is intended to address these challenges and improve the Pre-Sub program by: (1) Describing the types of information that FDA would recommend submitting in order to get the best possible feedback from FDA; (2) outlining the process by which FDA meetings should be scheduled; and (3) explaining the Agency’s expectations regarding advice given during the Pre-Sub process. This guidance outlines clear recommendations for sponsors and for FDA staff and managers as well as expected timeframes for scheduling meetings. FDA intends to provide the best possible advice in accordance with the information provided, ensure it is captured accurately in the meeting minutes drafted by the sponsor, and commit to that advice unless the circumstances sufficiently change such that our advice is no longer applicable, such as when a sponsor changes the intended use of their device after we provide feedback. It is also our intention to hold timely meetings with appropriate staff and managers present, if resources permit. However, both our ability to provide advice and to hold timely meetings are dependent on our receiving the necessary information in advance of the meeting. In addition, this guidance also describes the procedures that CDRH and CBER intend to follow when industry representatives or application sponsors request a meeting with review staff, either as the preferred method of feedback in response to a Pre-Sub, or to discuss an existing regulatory submission. This guidance also recommends how to prepare for meetings with FDA staff. FDA plans to revise the document as necessary to reflect any MDUFA III agreements. VerDate Mar<15>2010 17:08 Jul 12, 2012 Jkt 226001 II. Significance of Guidance This draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the Agency’s current thinking on Medical Device Pre-Submissions and Meetings with CDRH and CBER Staff. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute and regulations. III. Electronic Access Persons interested in obtaining a copy of the draft guidance may do so by using the Internet. To receive ‘‘Medical Devices: Pre-Submissions and Meetings with FDA Staff,’’ you may either send an email request to dsmica@fda.hhs.gov to receive an electronic copy of the document or send a fax request to 301– 847–8149 to receive a hard copy. Please use the document number 1677 to identify the guidance you are requesting. A search capability for all CDRH guidance documents is available at https://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/ GuidanceDocuments/default.htm; a search capability for all CBER guidance documents is available at https://www. fda.gov/BiologicsBloodVaccines/ GuidanceComplianceRegulatory Information/default.htm. Guidance documents are also available at https://www.regulations.gov. IV. Paperwork Reduction Act of 1995 Under the PRA (44 U.S.C. 3501– 3502), 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 before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice PO 00000 Frm 00065 Fmt 4703 Sfmt 4703 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. Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices: The Pre-Submission Program and Meetings With FDA Staff This draft guidance describes the PreSubmission program for medical devices reviewed in CDRH and CBER. The guidance provides recommendations regarding the information that should be submitted in a Pre-Submission Package and procedures that should be followed for meetings between CDRH and CBER staff and industry representatives or application sponsors. When final, this document will supersede ‘‘Pre-IDE Program: Issues and Answers—Blue Book Memo D99–1’’ dated March 25, 1999. A Pre-Submission is defined as a formal written request from an applicant for feedback from FDA to be provided in the form of a formal written response or, if the manufacturer chooses, a meeting or teleconference in which the feedback is documented in meeting minutes. A Pre-Submission is appropriate when FDA’s feedback on specific questions is necessary to guide product development and/or application preparation. The proposed collections of information are necessary to allow the Agency to receive PreSubmission Packages in order to implement this voluntary submission program. FDA estimates the burden of this collection of information as follows: E:\FR\FM\13JYN1.SGM 13JYN1 41415 Federal Register / Vol. 77, No. 135 / Friday, July 13, 2012 / Notices TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Submission of information for Pre-Submission Program Number of respondents Numer of responses per respondent Total annual responses Average burden per respondent (in hours) Total hours CDRH ................................................................................... CBER ................................................................................... 2465 79 1 1 2465 79 137 137 337,705 10,823 Total .............................................................................. 2544 1 2544 137 348,528 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Respondents are medical device manufacturers subject to FDA’s laws and regulations. FDA estimates that it will receive approximately 2544 presubmission packages annually. The Agency reached this estimate by reviewing the number of submissions received by the Agency under the PreIDE program over the past 10 years. Based on FDA’s experience with the Pre-IDE program, FDA expects the Pre- Submission program to continue to be utilized as a viable program in the future and expects that the number of pre-submission packages will increase over its current rate and reach a steady state of approximately 2544 submissions per year. FDA estimates from past experience with the Pre-IDE program that the complete process involved with the program takes approximately 137 hours. This average is based upon estimates by FDA administrative and technical staff that is familiar with the requirements for submission of a Pre-Submission and related materials, have consulted and advised manufacturers on these requirements, and have reviewed the documentation submitted. Therefore, the total reporting burden hours is estimated to be 348,528 hours. TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of respondents Total burden hours annualized Hourly wage rate Total cost annualized 2544 ............................................................................................................................................. 137 $150 $52,279,200 1 There are no capital costs or operating and maintenance costs associated with this collection of information. VI. References V. Comments srobinson on DSK4SPTVN1PROD with NOTICES The average to industry per hour for this type of work is $150, resulting in a cost of $20,550 per respondent. The estimated submission cost of $20,550 multiplied by 2544 submissions per year equals $52,279,200, which is the aggregated industry reporting cost annualized. This draft guidance also refers to previously approved information collections found in FDA regulations. The collections of information in 21 CFR part 803 are approved under OMB control number 0910–0437; the collections of information in 21 CFR part 807, subpart E is approved under OMB control number 0910–0120; and the collections of information in 21 CFR part 812 are approved under OMB control number 0910–0078. [FR Doc. 2012–17078 Filed 7–12–12; 8:45 am] Interested persons may submit to the Division of Dockets Management (see ADDRESSES), either electronic or written comments regarding this document. It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. BILLING CODE 4160–01–P VerDate Mar<15>2010 17:08 Jul 12, 2012 Jkt 226001 The following references have been placed on display in the Division of Dockets Management (see Comments) and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday. (FDA has verified the Web site addresses, but FDA is not responsible for any subsequent changes to the Web sites after this document publishes in the Federal Register.) 1. Please see 21 CFR 812.3(m) and FDA’s Web page on Clinical Trials, available at www.fda.gov/ ScienceResearch/SpecialTopics/ RunningClinicalTrials/default.htm. Dated: July 9, 2012. Leslie Kux, Assistant Commissioner for Policy. PO 00000 Frm 00066 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2012–N–0563] Single-Ingredient, Immediate-Release Drug Products Containing Oxycodone for Oral Administration and Labeled for Human Use; Enforcement Action Dates; Correction AGENCY: Food and Drug Administration, HHS. ACTION: Notice; correction. The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of July 6, 2012 (77 FR 40069). The document announced FDA’s intention to take enforcement action against all unapproved singleingredient, immediate-release drug products that contain oxycodone hydrochloride for oral administration and are labeled for human use, and persons who manufacture or cause the manufacture or distribution of such products in interstate commerce. The document was published with an incorrect Web link. This document corrects that error. SUMMARY: E:\FR\FM\13JYN1.SGM 13JYN1

Agencies

[Federal Register Volume 77, Number 135 (Friday, July 13, 2012)]
[Notices]
[Pages 41413-41415]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-17078]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-D-0530]

Draft Guidance for Industry and Food and Drug Administration
Staff; Medical Devices: The Pre-Submission Program and Meetings With
FDA Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the draft guidance entitled ``Medical Devices: The Pre-
Submission Program and Meetings with FDA Staff.'' The purpose of this
guidance is to describe the Pre-Submission program (formerly the pre-
Investigational Device Exemption (IDE) program) for medical devices
reviewed in the Center for Devices and Radiological Health (CDRH) and
the Center for Biologics Evaluation and Research (CBER). In addition,
the guidance provides recommendations regarding information that should
be included in a Pre-Submission Package. This guidance also describes
the procedures that CDRH and CBER intend to follow when industry
representatives or application sponsors request a meeting with review
staff. This draft guidance is not final nor is it in effect at this
time.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment of this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by October 11, 2012. Submit either written or electronic
comments on this collection of information by September 11, 2012.

ADDRESSES: Submit written requests for single copies of the draft
guidance document entitled ``Medical Devices: The Pre-Submission
Program and Meetings with FDA Staff'' to the Division of Small
Manufacturers, International and Consumer Assistance, Center for
Devices and Radiological Health, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, Rm. 4613, Silver Spring, MD 20993-0002;
or Office of Communication, Outreach and Development (HFM-40), Center
for Biologics Evaluation and Research (CBER), Food and Drug
Administration, 1401 Rockville Pike, Suite 200N, Rockville, MD 20852-
1448. Send one self-addressed adhesive label to assist that office in
processing your request, or fax your request to 301-847-8149. See the
SUPPLEMENTARY INFORMATION section for information on electronic access
to the guidance.
Submit electronic comments on the draft guidance to https://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852. Identify comments with the docket number
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:

Angela Krueger, Center for Devices and Radiological Health, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1666,
Silver Spring, MD 20993-0002, 301-796-6380; or
Stephen Ripley, Center for Biologics Evaluation and Research (HFM-17),
Food and Drug Administration, 1401 Rockville Pike, Suite 200N,
Rockville, MD 20852-1448, 301-827-6210.

SUPPLEMENTARY INFORMATION:

I. Background

Since its establishment in 1995, the pre-IDE program has been a
successful resource for both medical device applicants and the FDA.
Originally, this program was designed to provide applicants a mechanism
to obtain FDA feedback on future IDE applications prior to their
submission. Over time, the pre-IDE program evolved to include feedback
on other device submission program areas, such as Premarket Approval
(PMA) applications, Humanitarian Device Exemption (HDE) applications,
and Premarket Notification (510(k)) Submissions, as well as to address
questions related to whether a clinical study requires submission of an
IDE. The purpose of this guidance is to update the pre-IDE program to
reflect this broader scope and make important modifications to reflect
changes in the premarket program areas as a result of the Food and Drug
Administration Amendments Act of 2007 (FDAAA) (Pub. L. 110-85). This
guidance also broadens the scope of the program to include those
devices regulated by CBER. Accordingly, FDA is changing the name for
this program from the pre-IDE program to the Pre-Submission (Pre-Sub)
program.
The main purpose of the Pre-Sub program remains the same as the
pre-IDE program: to facilitate providing advice to applicants when they
have specific questions during product development and early protocol

[[Page 41414]]

planning, about device studies that present significant risk(s) (SR) as
well as non-significant risk(s) (NSR) or when developing protocols for
clinical studies conducted outside of the United States to support
future U.S. marketing applications (Ref. 1). Consequently, the Pre-Sub
program can provide an efficient path from device concept to market
while facilitating the Agency's goal of meeting FDAAA and Medical
Device User Fee Act of 2008 (MDUFA II) review milestones.
The Pre-Sub program has also faced several challenges, and the
guidance is intended to address these challenges and improve the Pre-
Sub program by: (1) Describing the types of information that FDA would
recommend submitting in order to get the best possible feedback from
FDA; (2) outlining the process by which FDA meetings should be
scheduled; and (3) explaining the Agency's expectations regarding
advice given during the Pre-Sub process.
This guidance outlines clear recommendations for sponsors and for
FDA staff and managers as well as expected timeframes for scheduling
meetings. FDA intends to provide the best possible advice in accordance
with the information provided, ensure it is captured accurately in the
meeting minutes drafted by the sponsor, and commit to that advice
unless the circumstances sufficiently change such that our advice is no
longer applicable, such as when a sponsor changes the intended use of
their device after we provide feedback. It is also our intention to
hold timely meetings with appropriate staff and managers present, if
resources permit. However, both our ability to provide advice and to
hold timely meetings are dependent on our receiving the necessary
information in advance of the meeting.
In addition, this guidance also describes the procedures that CDRH
and CBER intend to follow when industry representatives or application
sponsors request a meeting with review staff, either as the preferred
method of feedback in response to a Pre-Sub, or to discuss an existing
regulatory submission. This guidance also recommends how to prepare for
meetings with FDA staff. FDA plans to revise the document as necessary
to reflect any MDUFA III agreements.

II. Significance of Guidance

This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the Agency's current thinking on Medical
Device Pre-Submissions and Meetings with CDRH and CBER Staff. It does
not create or confer any rights for or on any person and does not
operate to bind FDA or the public. An alternative approach may be used
if such approach satisfies the requirements of the applicable statute
and regulations.

III. Electronic Access

Persons interested in obtaining a copy of the draft guidance may do
so by using the Internet. To receive ``Medical Devices: Pre-Submissions
and Meetings with FDA Staff,'' you may either send an email request to
dsmica@fda.hhs.gov to receive an electronic copy of the document or
send a fax request to 301-847-8149 to receive a hard copy. Please use
the document number 1677 to identify the guidance you are requesting. A
search capability for all CDRH guidance documents is available at
https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm; a search capability for all CBER
guidance documents is available at https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm. Guidance documents are also available at https://www.regulations.gov.

IV. Paperwork Reduction Act of 1995

Under the PRA (44 U.S.C. 3501-3502), 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 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.

Draft Guidance for Industry and Food and Drug Administration Staff;
Medical Devices: The Pre-Submission Program and Meetings With FDA Staff

This draft guidance describes the Pre-Submission program for
medical devices reviewed in CDRH and CBER. The guidance provides
recommendations regarding the information that should be submitted in a
Pre-Submission Package and procedures that should be followed for
meetings between CDRH and CBER staff and industry representatives or
application sponsors. When final, this document will supersede ``Pre-
IDE Program: Issues and Answers--Blue Book Memo D99-1'' dated March 25,
1999.
A Pre-Submission is defined as a formal written request from an
applicant for feedback from FDA to be provided in the form of a formal
written response or, if the manufacturer chooses, a meeting or
teleconference in which the feedback is documented in meeting minutes.
A Pre-Submission is appropriate when FDA's feedback on specific
questions is necessary to guide product development and/or application
preparation. The proposed collections of information are necessary to
allow the Agency to receive Pre-Submission Packages in order to
implement this voluntary submission program.
FDA estimates the burden of this collection of information as
follows:

[[Page 41415]]

Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Average
Submission of information for Number of Numer of Total annual burden per
Pre-Submission Program respondents responses per responses respondent Total hours
respondent (in hours)
----------------------------------------------------------------------------------------------------------------
CDRH............................ 2465 1 2465 137 337,705
CBER............................ 79 1 79 137 10,823
-------------------------------------------------------------------------------
Total....................... 2544 1 2544 137 348,528
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.

Respondents are medical device manufacturers subject to FDA's laws
and regulations. FDA estimates that it will receive approximately 2544
pre-submission packages annually. The Agency reached this estimate by
reviewing the number of submissions received by the Agency under the
Pre-IDE program over the past 10 years. Based on FDA's experience with
the Pre-IDE program, FDA expects the Pre-Submission program to continue
to be utilized as a viable program in the future and expects that the
number of pre-submission packages will increase over its current rate
and reach a steady state of approximately 2544 submissions per year.
FDA estimates from past experience with the Pre-IDE program that
the complete process involved with the program takes approximately 137
hours. This average is based upon estimates by FDA administrative and
technical staff that is familiar with the requirements for submission
of a Pre-Submission and related materials, have consulted and advised
manufacturers on these requirements, and have reviewed the
documentation submitted.
Therefore, the total reporting burden hours is estimated to be
348,528 hours.

Table 2--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Total burden
Number of respondents hours Hourly wage Total cost
annualized rate annualized
----------------------------------------------------------------------------------------------------------------
2544......................................................... 137 $150 $52,279,200
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.

The average to industry per hour for this type of work is $150,
resulting in a cost of $20,550 per respondent. The estimated submission
cost of $20,550 multiplied by 2544 submissions per year equals
$52,279,200, which is the aggregated industry reporting cost
annualized.
This draft guidance also refers to previously approved information
collections found in FDA regulations. The collections of information in
21 CFR part 803 are approved under OMB control number 0910-0437; the
collections of information in 21 CFR part 807, subpart E is approved
under OMB control number 0910-0120; and the collections of information
in 21 CFR part 812 are approved under OMB control number 0910-0078.

V. Comments

Interested persons may submit to the Division of Dockets Management
(see ADDRESSES), either electronic or written comments regarding this
document. It is only necessary to send one set of comments. Identify
comments with the docket number found in brackets in the heading of
this document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.

VI. References

The following references have been placed on display in the
Division of Dockets Management (see Comments) and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday.
(FDA has verified the Web site addresses, but FDA is not responsible
for any subsequent changes to the Web sites after this document
publishes in the Federal Register.)
1. Please see 21 CFR 812.3(m) and FDA's Web page on Clinical
Trials, available at www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/default.htm.

Dated: July 9, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-17078 Filed 7-12-12; 8:45 am]
BILLING CODE 4160-01-P

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