83 FR 48822 - Agency Information Collection Activities; Proposed Collection; Comment Request; Assessment of Combination Product Review Practices
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 188 (September 27, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 188 (September 27, 2018)
| Page Range | 48822-48824 | |
| FR Document | 2018-21038 |
[Federal Register Volume 83, Number 188 (Thursday, September 27, 2018)] [Notices] [Pages 48822-48824] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-21038] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-N-2969] Agency Information Collection Activities; Proposed Collection; Comment Request; Assessment of Combination Product Review Practices 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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on a proposed information collection involving interviews with entities that submit a Request for Designation (RFD) or pre-RFD, an Investigational New Drug (IND) application or pre-IND request, or a New Drug Application (NDA) or Biologics License Application (BLA) for a combination product to FDA. DATES: Submit either electronic or written comments on the collection of information by November 26, 2018. 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 November 26, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of November 26, 2018. 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-2969 for ``Assessment of Combination Product Review Practices.'' 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 [[Page 48823]] 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 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: Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726, [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 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. Assessment of Combination Product Review Practices OMB Control Number 0910--NEW In 1991, FDA's Center for Biologics Evaluation and Research (CBER), Center for Drug Evaluation and Research (CDER), and Center for Devices and Radiological Health (CDRH) entered into ``Intercenter Agreements'' to provide guidance on the classification and assignment of medical products and to clarify jurisdiction over combination product reviews. With the enactment of the Medical Device User Fee and Modernization Act (MDUFMA) of 2002, FDA aimed to achieve prompt assignment of combination products, timely and effective premarket reviews, and consistent and appropriate postmarket regulation through the establishment of the Office of Combination Products (OCP). Since then, OCP has operated to further standardize combination product guidance to FDA and industry and facilitate coordination between FDA's medical product review Centers. As part of the 2017 reauthorization of the Prescription Drug User Fee Act (PDUFA), FDA committed to advance the development of drug- device and biologic-device combination products regulated by CDER and CBER through modernization of the combination product review program. To that end, FDA committed to contracting with an independent third party to assess current practices for combination drug product review, to include interviews with combination product sponsors and applicants. The contractor for the assessment of combination drug product review practices is Eastern Research Group, Inc. (ERG). Therefore, in accordance with the PDUFA VI Commitment Letter, FDA proposes to have ERG conduct independent interviews of combination product sponsors and applicants during the data collection period as follows: Sponsors with a Request For Designation (RFD) or pre-RFD submitted during the data collection period. Sponsors with a combination product Investigational New Drug (IND) or pre-IND submitted during the data collection period. Applicants with a combination product New Drug Application (NDA) or Biologics License Application (BLA) that receives a first- cycle action from FDA during the data collection period. The purpose of these interviews is to collect voluntary feedback from combination product sponsors and applicants on their experience with FDA during the development and review of their products, including any challenges or best practices. ERG will anonymize and aggregate sponsor/applicant responses prior to inclusion in the assessment. ERG will use interview responses to complement and supplement data on combination product review parameters obtained through other means, such as extraction of data from FDA corporate databases and interviews with FDA review staff. FDA will publish ERG's assessment (with interview results and findings) on the Agency's public website and a link to the assessment in the Federal Register for public comment. Sponsors submit approximately 150 to 180 RFDs/pre-RFDs and 200 to 240 combination product original INDs/pre-INDs per year. ERG will interview 1 to 3 sponsor representatives at a time for up to 35 RFDs/ pre-RFDs and 48 INDs received by FDA--up to 105 RFD/pre-RFD and 144 IND/pre-IND sponsor representatives per year. FDA typically reviews approximately 25 to 30 combination product original NDAs and original BLAs per year. ERG will interview 1 to 3 applicant representatives at a time for each application that receives a first-cycle action from FDA-- up to 90 representatives per year. Thus, FDA estimates the burden of this collection of information as follows: [[Page 48824]] Table 1--Estimated Annual Reporting Burden \1\ ---------------------------------------------------------------------------------------------------------------- Number of Portion of study Number of responses per Total annual Average burden Total hours respondents respondent responses per response \1\ ---------------------------------------------------------------------------------------------------------------- Pre-test........................ 5 1 5 1.5 7.5 Interviews...................... 339 1 339 1.5 508.5 ------------------------------------------------------------------------------- Total....................... .............. .............. .............. .............. 516 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. ERG will conduct a pretest of the interview protocol with five respondents. FDA estimates that it will take 1.0 to 1.5 hours to complete the pretest, for a total of a maximum of 7.5 hours. FDA estimates that up to 339 respondents will take part in the interviews each year, with each interview lasting 1.0 to 1.5 hours, for a total of a maximum of 508.5 hours. Thus, the total estimated annual burden is 516 hours. FDA's burden estimate is based on prior experience with similar interviews with the regulated community. Dated: September 21, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-21038 Filed 9-26-18; 8:45 am] BILLING CODE 4164-01-P
![48822 Federal Register / Vol. 83, No. 188 / Thursday, September 27, 2018 / Notices
Third-Party Disclosure Burden information when applying for research from 5 to 15 minutes; we used the mean,
Under § 54.4(b), clinical investigators grants. Also, most people know the 10 minutes, for the average burden per
supply to the sponsor of a covered study financial holdings of their immediate disclosure. The number of respondents
financial information sufficient to allow family and records of such interests are is the sum of the number of affected
the sponsor to submit complete and generally accessible because they are applications multiplied by the mean
accurate certification or disclosure needed for preparing tax records. For (rounded) of the estimated number of
statements. Clinical investigators are these reasons, FDA estimates that the investigators for each application type
accustomed to supplying such time required for this task may range (see table 1).
TABLE 4—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of
Number of disclosures Total annual
21 CFR section Average burden per disclosure Total hours 2
respondents per disclosures
respondent
54.4(b)—Clinical Investigators .......... 7,894 1 7,894 0.17 (10 minutes) ............................. 1,342
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
2 Numbers have been rounded.
Our estimated burden for the application or pre-IND request, or a New • If you want to submit a comment
information collection reflects an Drug Application (NDA) or Biologics with confidential information that you
overall increase of 222 hours and a License Application (BLA) for a do not wish to be made available to the
corresponding increase of 893 combination product to FDA. public, submit the comment as a
responses/records. We attribute this DATES: Submit either electronic or written/paper submission and in the
adjustment to an increase in the number written comments on the collection of manner detailed (see ‘‘Written/Paper
of affected applications and the number information by November 26, 2018. Submissions’’ and ‘‘Instructions’’).
of investigators. No program changes
ADDRESSES: You may submit comments Written/Paper Submissions
were made.
as follows. Please note that late, Submit written/paper submissions as
Dated: September 21, 2018.
untimely filed comments will not be follows:
Leslie Kux, considered. Electronic comments must • Mail/Hand Delivery/Courier (for
Associate Commissioner for Policy. be submitted on or before November 26, written/paper submissions): Dockets
[FR Doc. 2018–21039 Filed 9–26–18; 8:45 am] 2018. The https://www.regulations.gov Management Staff (HFA–305), Food and
BILLING CODE 4164–01–P electronic filing system will accept Drug Administration, 5630 Fishers
comments until midnight Eastern Time Lane, Rm. 1061, Rockville, MD 20852.
at the end of November 26, 2018. • For written/paper comments
DEPARTMENT OF HEALTH AND Comments received by mail/hand submitted to the Dockets Management
HUMAN SERVICES delivery/courier (for written/paper Staff, FDA will post your comment, as
submissions) will be considered timely well as any attachments, except for
Food and Drug Administration if they are postmarked or the delivery information submitted, marked and
[Docket No. FDA–2018–N–2969] service acceptance receipt is on or identified, as confidential, if submitted
before that date. as detailed in ‘‘Instructions.’’
Agency Information Collection
Electronic Submissions Instructions: All submissions received
Activities; Proposed Collection;
must include the Docket No. FDA–
Comment Request; Assessment of Submit electronic comments in the 2018–N–2969 for ‘‘Assessment of
Combination Product Review Practices following way: Combination Product Review
AGENCY: Food and Drug Administration, • Federal eRulemaking Portal: Practices.’’ Received comments, those
HHS. https://www.regulations.gov. Follow the filed in a timely manner (see
ACTION: Notice. instructions for submitting comments. ADDRESSES), will be placed in the docket
Comments submitted electronically, and, except for those submitted as
SUMMARY: The Food and Drug including attachments, to https:// ‘‘Confidential Submissions,’’ publicly
Administration (FDA or Agency) is www.regulations.gov will be posted to viewable at https://www.regulations.gov
announcing an opportunity for public the docket unchanged. Because your or at the Dockets Management Staff
comment on the proposed collection of comment will be made public, you are between 9 a.m. and 4 p.m., Monday
certain information by the Agency. solely responsible for ensuring that your through Friday.
Under the Paperwork Reduction Act of comment does not include any • Confidential Submissions—To
1995 (PRA), Federal Agencies are confidential information that you or a submit a comment with confidential
required to publish notice in the third party may not wish to be posted, information that you do not wish to be
Federal Register concerning each such as medical information, your or made publicly available, submit your
proposed collection of information and anyone else’s Social Security number, or comments only as a written/paper
daltland on DSKBBV9HB2PROD with NOTICES
to allow 60 days for public comment in confidential business information, such submission. You should submit two
response to the notice. This notice as a manufacturing process. Please note copies total. One copy will include the
solicits comments on a proposed that if you include your name, contact information you claim to be confidential
information collection involving information, or other information that with a heading or cover note that states
interviews with entities that submit a identifies you in the body of your ‘‘THIS DOCUMENT CONTAINS
Request for Designation (RFD) or pre- comments, that information will be CONFIDENTIAL INFORMATION.’’ The
RFD, an Investigational New Drug (IND) posted on https://www.regulations.gov. Agency will review this copy, including
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![48824 Federal Register / Vol. 83, No. 188 / Thursday, September 27, 2018 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
Portion of study responses per burden per Total hours 1
respondents responses
respondent response
Pre-test ................................................................................. 5 1 5 1.5 7.5
Interviews ............................................................................. 339 1 339 1.5 508.5
Total .............................................................................. ........................ ........................ ........................ ........................ 516
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
ERG will conduct a pretest of the DATES: FDA is reopening the comment information submitted, marked and
interview protocol with five period on the notice of availability identified, as confidential, if submitted
respondents. FDA estimates that it will published March 27, 2008 (73 FR as detailed in ‘‘Instructions.’’
take 1.0 to 1.5 hours to complete the 16311). Submit either electronic or Instructions: All submissions received
pretest, for a total of a maximum of 7.5 written comments on the draft must include the Docket No. FDA–
hours. FDA estimates that up to 339 guidances by December 26, 2018, to 2008–D–0180 for ‘‘Coronary Drug-
respondents will take part in the ensure that the Agency considers your Eluting Stents—Nonclinical and
interviews each year, with each comment on the draft guidances before Clinical Studies’’ and ‘‘Coronary Drug-
interview lasting 1.0 to 1.5 hours, for a it begins work on the final version of the Eluting Stents—Nonclinical and
total of a maximum of 508.5 hours. guidances. Clinical Studies Draft Companion
Thus, the total estimated annual burden ADDRESSES: You may submit comments Guidance Document.’’ Received
is 516 hours. FDA’s burden estimate is on any guidance at any time as follows: comments will be placed in the docket
based on prior experience with similar and, except for those submitted as
Electronic Submissions
interviews with the regulated ‘‘Confidential Submissions,’’ publicly
community. Submit electronic comments in the viewable at https://www.regulations.gov
following way: or at the Dockets Management Staff
Dated: September 21, 2018.
• Federal eRulemaking Portal: between 9 a.m. and 4 p.m., Monday
Leslie Kux, https://www.regulations.gov. Follow the through Friday.
Associate Commissioner for Policy. instructions for submitting comments. • Confidential Submissions—To
[FR Doc. 2018–21038 Filed 9–26–18; 8:45 am] Comments submitted electronically, submit a comment with confidential
BILLING CODE 4164–01–P including attachments, to https:// information that you do not wish to be
www.regulations.gov will be posted to made publicly available, submit your
the docket unchanged. Because your comments only as a written/paper
DEPARTMENT OF HEALTH AND comment will be made public, you are submission. You should submit two
HUMAN SERVICES solely responsible for ensuring that your copies total. One copy will include the
comment does not include any information you claim to be confidential
Food and Drug Administration confidential information that you or a with a heading or cover note that states
[Docket No. FDA–2008–D–0180] third party may not wish to be posted, ‘‘THIS DOCUMENT CONTAINS
such as medical information, your or CONFIDENTIAL INFORMATION.’’ The
Coronary Drug-Eluting Stents— anyone else’s Social Security number, or Agency will review this copy, including
Nonclinical and Clinical Studies and confidential business information, such the claimed confidential information, in
Companion Guidance Document; Draft as a manufacturing process. Please note its consideration of comments. The
Guidance for Industry and Food and that if you include your name, contact second copy, which will have the
Drug Administration Staff; Availability; information, or other information that
claimed confidential information
Reopening of the Comment Period identifies you in the body of your
redacted/blacked out, will be available
comments, that information will be
AGENCY: Food and Drug Administration, for public viewing and posted on
posted on https://www.regulations.gov.
HHS. • If you want to submit a comment https://www.regulations.gov. Submit
Notice; reopening of the
ACTION: with confidential information that you both copies to the Dockets Management
comment period. do not wish to be made available to the Staff. If you do not wish your name and
public, submit the comment as a contact information to be made publicly
SUMMARY: The Food and Drug written/paper submission and in the available, you can provide this
Administration (FDA or the Agency) is manner detailed (see ‘‘Written/Paper information on the cover sheet and not
reopening the comment period for the Submissions’’ and ‘‘Instructions’’). in the body of your comments and you
notice of availability, published in the must identify this information as
Federal Register of March 27, 2008. In Written/Paper Submissions ‘‘confidential.’’ Any information marked
that document, FDA requested Submit written/paper submissions as as ‘‘confidential’’ will not be disclosed
comments on two draft guidance follows: except in accordance with 21 CFR 10.20
documents entitled ‘‘Coronary Drug- • Mail/Hand Delivery/Courier (for and other applicable disclosure law. For
Eluting Stents—Nonclinical and written/paper submissions): Dockets more information about FDA’s posting
daltland on DSKBBV9HB2PROD with NOTICES
Clinical Studies’’ and ‘‘Coronary Drug- Management Staff (HFA–305), Food and of comments to public dockets, see 80
Eluting Stents—Nonclinical and Drug Administration, 5630 Fishers FR 56469, September 18, 2015, or access
Clinical Studies Draft Companion Lane, Rm. 1061, Rockville, MD 20852. the information at: https://www.gpo.gov/
Guidance Document.’’ The Agency is • For written/paper comments fdsys/pkg/FR-2015-09-18/pdf/2015-
reopening the comment period to allow submitted to the Dockets Management 23389.pdf.
interested persons to provide updated Staff, FDA will post your comment, as Docket: For access to the docket to
comments and any new information. well as any attachments, except for read background documents or the
VerDate Sep<11>2014 17:20 Sep 26, 2018 Jkt 244001 PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 E:\FR\FM\27SEN1.SGM 27SEN1](https://thefederalregister.org/doc/83_FR_49010/page/3.svg)
Document Created: 2018-09-27 01:04:47
Document Modified: 2018-09-27 01:04:47
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Submit either electronic or written comments on the collection of information by November 26, 2018. | |
| Contact | Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726, [email protected] | |
| FR Citation | 83 FR 48822 |
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