83 FR 1363 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Certification To Accompany Drug, Biological Product, and Device Applications or Submissions
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 8 (January 11, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 8 (January 11, 2018)
| Page Range | 1363-1365 | |
| FR Document | 2018-00354 |
[Federal Register Volume 83, Number 8 (Thursday, January 11, 2018)] [Notices] [Pages 1363-1365] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-00354] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0275] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Certification To Accompany Drug, Biological Product, and Device Applications or Submissions AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of information by February 12, 2018. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, Fax: 202-395-7285, or emailed to [email protected]. All comments should be identified with the OMB control number 0910-0616. Also include the FDA docket number found in brackets in the heading of this document. 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: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. Certification To Accompany Drug, Biological Product, and Device Applications or Submissions (Form FDA 3674) OMB Control Number 0910-0616--Extension The information required under section 402(j)(5)(B) of the Public Health Service Act (PHS Act) (42 U.S.C. 282(j)(5)(B)) is submitted in the form of a certification, Form FDA 3674, which accompanies applications and submissions currently submitted to FDA and already approved by OMB. The OMB control numbers and expiration dates for those applications and submissions are: 21 CFR parts 312 and 314 (human drugs), OMB control number 0910-0014, expiring February 28, 2019, and OMB control number 0910-0001, expiring December 31, 2017; 21 CFR parts 312 and 601 (biological products), OMB control number 0910-0014, expiring February 28, 2019, and OMB control number 0910-0338, expiring March 31, 2020; and 21 CFR parts 807 and 814 (devices), OMB control number 0910-0120, expiring June 30, 2020, and OMB control number 0910- 0231, expiring March 31, 2020. Title VIII of the Food and Drug Administration Amendments Act of 2007 (Pub. L. 110-85) amended the PHS Act by adding section 402(j). The provisions broadened the scope of clinical trials subject to submitting information and required additional information to be submitted to the clinical trials databank (https://clinicaltrials.gov) (FDA has verified the website address, but FDA is not responsible for any subsequent changes to the website after this document publishes in the Federal Register) previously established by the National Institutes of Health (NIH)/National Library of Medicine. This includes expanded information on applicable clinical trials and summary information on the results of certain clinical trials. The provisions include responsibilities for FDA as well as several amendments to the Federal Food, Drug, and Cosmetic Act (FD&C Act). One provision, section 402(j)(5)(B) of the PHS Act, requires that a certification accompany human drug, biological, and device product submissions made to FDA. Specifically, at the time of submission of an application under sections 505, 515, or 520(m) of the FD&C Act (21 U.S.C. 355, 360e, or 360j(m)), or under section 351 of the PHS Act (42 U.S.C. 262), or submission of a report under section 510(k) of the FD&C Act (21 U.S.C. 360(k)), such application or submission must be accompanied by a certification, Form FDA 3674, that all applicable requirements of section 402(j) of the PHS Act have been met. Where available, such certification must include the appropriate National Clinical Trial (NCT) numbers that are assigned upon submission of required information to the NIH databank at https://clinicaltrials.gov. The proposed extension of the collection of information is necessary to satisfy the previously mentioned statutory requirement. The importance of obtaining these data relates to adherence to the legal requirements for submissions to the clinical trials registry and results databank, and ensuring that individuals and organizations submitting applications or reports to FDA under the listed provisions of the FD&C Act or the PHS Act adhere to the appropriate legal and regulatory requirements for certifying to having complied with those requirements. The failure to submit the certification required by section 402(j)(5)(B) of the PHS Act, and the knowing submission of a false certification, are both prohibited acts under section 301 of the FD&C Act (21 U.S.C. 331). Violations are subject to civil money penalties. The Form FDA 3674 provides a convenient mechanism for sponsors/applicants/submitters to satisfy the certification requirements of the statutory provision. To assist sponsors/applicants/submitters in understanding the statutory requirements associated with Form FDA 3674, we have provided a guidance available at: https://www.fda.gov/RegulatoryInformation/Guidances/ucm125335.htm. This guidance recommends the applications and submissions FDA considers should be accompanied by the certification form, Form FDA 3674. The applications and submissions identified in the guidance are reflected in the burden analysis. In 2017, we updated the guidance to include references to the NIH Final Rule implementing 402(j) of the PHS Act (42 U.S.C. 282(j)). The final rule, published on September 21, 2016 (81 FR 64982) (42 CFR part 11), clarifies the requirements for submission of clinical trial information to https://clinicaltrials.gov. Investigational New Drug Applications. FDA's Center for Drug Evaluation and Research (CDER) received 1,669 investigational new drug applications (INDs) and 15,285 clinical protocol IND amendments in calendar year (CY) 2016. CDER anticipates that IND and clinical protocol amendment submission rates will remain at or near this level in the near future. FDA's Center for Biologics Evaluation and Research (CBER) received 381 new [[Page 1364]] INDs and 456 clinical protocol IND amendments in CY 2016. CBER anticipates that IND and clinical protocol amendment submission rates will remain at or near this level in the near future. The estimated total number of submissions (new INDs and new protocol submissions) subject to mandatory certification requirements under section 402(j)(5)(B) of the PHS Act is 16,954 for CDER plus 837 for CBER, or 17,791 submissions per year. The minutes per response is the estimated number of minutes that a respondent would spend preparing the information to be submitted to FDA under section 402(j)(5)(B) of the PHS Act, including the time it takes to enter the necessary information on the form. Based on its experience with current submissions, FDA estimates that approximately 15 minutes on average would be needed per response for certifications that accompany IND applications and clinical protocol amendment submissions. It is assumed that most submissions to investigational applications will reference only a few protocols for which the sponsor/applicant/submitter has obtained an NCT number from https://clinicaltrials.gov prior to making the submission to FDA. It is also assumed that the sponsor/applicant/submitter has electronic capabilities allowing them to retrieve the information necessary to complete the form in an efficient manner. Marketing Applications/Submissions. In CY 2016, CDER and CBER received 252 new drug applications (NDA)/biologics license applications (BLA)/resubmissions and 1,067 NDA/BLA amendments for which certifications are needed. CDER and CBER received 253 efficacy supplements/resubmissions to previously approved NDAs/BLAs in CY 2016. CDER and CBER anticipate that new drug/biologic applications/ resubmissions and efficacy supplement submission rates will remain at or near this level in the near future. FDA's Center for Devices and Radiological Health (CDRH) received a total of 330 new applications for premarket approvals (PMA), 510(k) submissions containing clinical information, PMA supplements, applications for humanitarian device exemptions (HDE) and amendments in CY 2016. CDRH anticipates that application, amendment, supplement, and annual report submission rates will remain at or near this level in the near future. FDA's Office of Generic Drugs (OGD) received 1,036 abbreviated new drug applications (ANDAs) in 2016. OGD received 698 bioequivalence amendments/supplements in 2016. OGD anticipates that application, amendment, and supplement submission rates will remain at or near this level in the near future. Based on its experience reviewing NDAs, BLAs, PMAs, HDEs, 510(k)s, and ANDAs and experience with current submissions of Form FDA 3674, FDA estimates that approximately 45 minutes on average would be needed per response for certifications that accompany NDA, BLA, PMA, HDE, 510(k), and ANDA marketing applications and submissions. It is assumed that the sponsor/applicant/submitter has electronic capabilities allowing them to retrieve the information necessary to complete the form in an efficient manner. In the Federal Register of September 22, 2017 (82 FR 44417), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received. FDA estimates the burden of this collection of information as follows: Table 1--Estimated Annual Reporting Burden \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of Number of respondents respondents Number of Total annual FDA Center/Activity (investigational (marketing responses per responses Average burden per response Total hours applications) applications) respondent -------------------------------------------------------------------------------------------------------------------------------------------------------- CDER -------------------------------------------------------------------------------------------------------------------------------------------------------- New Applications (IND)............. 1,669 .............. 1 1,669 0.25 (15 minutes)................ 417 Clinical Protocol Amendments (IND). 15,285 .............. 1 15,285 0.25 (15 minutes)................ 3,821 New Marketing Applications/ ................ 198 1 198 0.75 (45 minutes)................ 149 Resubmissions (NDA/BLA). Clinical Amendments to Marketing ................ 1,067 1 1,067 0.75 (45 minutes)................ 800 Applications. Efficacy Supplements/ Resubmissions ................ 219 1 219 0.75 (45 minutes)................ 164 -------------------------------------------------------------------------------------------------------------------------------------------------------- CBER -------------------------------------------------------------------------------------------------------------------------------------------------------- New Applications (IND)............. 381 .............. 1 381 0.25 (15 minutes)................ 95 Clinical Protocol Amendments (IND). 456 .............. 1 456 0.25 (15 minutes)................ 114 New Marketing Applications/ ................ 54 1 54 0.75 (45 minutes)................ 41 Resubmissions (NDA/BLA). Clinical Amendments to Marketing ................ 0 1 0 0.75 (45 minutes)................ 0 Applications. Efficacy Supplements/ Resubmissions ................ 34 1 34 0.75 (45 minutes)................ 26 (BLA only). -------------------------------------------------------------------------------------------------------------------------------------------------------- CDRH -------------------------------------------------------------------------------------------------------------------------------------------------------- New Marketing Applications ................ 330 1 330 0.75 (45 minutes)................ 247 (includes PMAs, HDEs, Supplements and 510(k)s expected to contain clinical data). -------------------------------------------------------------------------------------------------------------------------------------------------------- [[Page 1365]] OGD -------------------------------------------------------------------------------------------------------------------------------------------------------- Original Applications.............. ................ 1,036 1 .............. 0.75 (45 minutes)................ 777 Bioequivalence Supplements/ ................ 698 1 .............. 0.75 (45 minutes)................ 524 Amendments. -------------------------------------------------------------------------------------------------------------------- Total.......................... ................ .............. .............. .............. ................................. 7,175 -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: January 8, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-00354 Filed 1-10-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 8 / Thursday, January 11, 2018 / Notices 1363
Board of Governors of the Federal Reserve Certification To Accompany Drug, FDA 3674, that all applicable
System, January 8, 2018. Biological Product, and Device requirements of section 402(j) of the
Ann E. Misback, Applications or Submissions (Form PHS Act have been met. Where
Secretary of the Board. FDA 3674) available, such certification must
include the appropriate National
[FR Doc. 2018–00341 Filed 1–10–18; 8:45 am] OMB Control Number 0910–0616—
Clinical Trial (NCT) numbers that are
BILLING CODE P Extension
assigned upon submission of required
The information required under information to the NIH databank at
section 402(j)(5)(B) of the Public Health https://clinicaltrials.gov.
Service Act (PHS Act) (42 U.S.C. The proposed extension of the
DEPARTMENT OF HEALTH AND 282(j)(5)(B)) is submitted in the form of collection of information is necessary to
HUMAN SERVICES a certification, Form FDA 3674, which satisfy the previously mentioned
accompanies applications and statutory requirement. The importance
Food and Drug Administration submissions currently submitted to FDA of obtaining these data relates to
and already approved by OMB. The adherence to the legal requirements for
[Docket No. FDA–2011–N–0275] OMB control numbers and expiration submissions to the clinical trials registry
dates for those applications and and results databank, and ensuring that
Agency Information Collection submissions are: 21 CFR parts 312 and individuals and organizations
Activities; Submission for Office of 314 (human drugs), OMB control submitting applications or reports to
Management and Budget Review; number 0910–0014, expiring February FDA under the listed provisions of the
Comment Request; Certification To 28, 2019, and OMB control number FD&C Act or the PHS Act adhere to the
Accompany Drug, Biological Product, 0910–0001, expiring December 31, 2017; appropriate legal and regulatory
and Device Applications or 21 CFR parts 312 and 601 (biological requirements for certifying to having
Submissions products), OMB control number 0910– complied with those requirements. The
0014, expiring February 28, 2019, and failure to submit the certification
AGENCY: Food and Drug Administration, OMB control number 0910–0338, required by section 402(j)(5)(B) of the
HHS. expiring March 31, 2020; and 21 CFR PHS Act, and the knowing submission
parts 807 and 814 (devices), OMB of a false certification, are both
ACTION: Notice. control number 0910–0120, expiring prohibited acts under section 301 of the
June 30, 2020, and OMB control number FD&C Act (21 U.S.C. 331). Violations are
SUMMARY: The Food and Drug 0910–0231, expiring March 31, 2020. subject to civil money penalties. The
Administration (FDA) is announcing Title VIII of the Food and Drug Form FDA 3674 provides a convenient
that a proposed collection of Administration Amendments Act of mechanism for sponsors/applicants/
information has been submitted to the 2007 (Pub. L. 110–85) amended the PHS submitters to satisfy the certification
Office of Management and Budget Act by adding section 402(j). The requirements of the statutory provision.
(OMB) for review and clearance under provisions broadened the scope of To assist sponsors/applicants/
the Paperwork Reduction Act of 1995. clinical trials subject to submitting submitters in understanding the
information and required additional statutory requirements associated with
DATES: Fax written comments on the information to be submitted to the Form FDA 3674, we have provided a
collection of information by February clinical trials databank (https:// guidance available at: https://
12, 2018. clinicaltrials.gov) (FDA has verified the www.fda.gov/RegulatoryInformation/
ADDRESSES: To ensure that comments on website address, but FDA is not Guidances/ucm125335.htm. This
the information collection are received, responsible for any subsequent changes guidance recommends the applications
to the website after this document and submissions FDA considers should
OMB recommends that written
publishes in the Federal Register) be accompanied by the certification
comments be faxed to the Office of
previously established by the National form, Form FDA 3674. The applications
Information and Regulatory Affairs, Institutes of Health (NIH)/National and submissions identified in the
OMB, Attn: FDA Desk Officer, Fax: 202– Library of Medicine. This includes guidance are reflected in the burden
395–7285, or emailed to oira_ expanded information on applicable analysis. In 2017, we updated the
submission@omb.eop.gov. All clinical trials and summary information guidance to include references to the
comments should be identified with the on the results of certain clinical trials. NIH Final Rule implementing 402(j) of
OMB control number 0910–0616. Also The provisions include responsibilities the PHS Act (42 U.S.C. 282(j)). The final
include the FDA docket number found for FDA as well as several amendments rule, published on September 21, 2016
in brackets in the heading of this to the Federal Food, Drug, and Cosmetic (81 FR 64982) (42 CFR part 11), clarifies
document. Act (FD&C Act). the requirements for submission of
One provision, section 402(j)(5)(B) of clinical trial information to https://
FOR FURTHER INFORMATION CONTACT: the PHS Act, requires that a certification clinicaltrials.gov.
Amber Sanford, Office of Operations, accompany human drug, biological, and Investigational New Drug
Food and Drug Administration, Three device product submissions made to Applications. FDA’s Center for Drug
White Flint North, 10A–12M, 11601 FDA. Specifically, at the time of Evaluation and Research (CDER)
Landsdown St., North Bethesda, MD submission of an application under received 1,669 investigational new drug
20852, 301–796–8867, PRAStaff@ sections 505, 515, or 520(m) of the applications (INDs) and 15,285 clinical
srobinson on DSK9F5VC42PROD with NOTICES
fda.hhs.gov. FD&C Act (21 U.S.C. 355, 360e, or protocol IND amendments in calendar
360j(m)), or under section 351 of the year (CY) 2016. CDER anticipates that
SUPPLEMENTARY INFORMATION: In PHS Act (42 U.S.C. 262), or submission IND and clinical protocol amendment
compliance with 44 U.S.C. 3507, FDA of a report under section 510(k) of the submission rates will remain at or near
has submitted the following proposed FD&C Act (21 U.S.C. 360(k)), such this level in the near future.
collection of information to OMB for application or submission must be FDA’s Center for Biologics Evaluation
review and clearance. accompanied by a certification, Form and Research (CBER) received 381 new
VerDate Sep<11>2014 00:05 Jan 11, 2018 Jkt 244001 PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 E:\FR\FM\11JAN1.SGM 11JAN1](https://thefederalregister.org/doc/83_FR_1371/page/1.svg)
![Federal Register / Vol. 83, No. 8 / Thursday, January 11, 2018 / Notices 1365
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Number of re- Number of re- Number of re-
spondents spondents Total annual Average burden per
FDA Center/Activity sponses per Total hours
(investigational (marketing ap- responses response
respondent
applications) plications)
OGD
Original Applications .................... ........................ 1,036 1 ........................ 0.75 (45 minutes) ...... 777
Bioequivalence Supplements/ ........................ 698 1 ........................ 0.75 (45 minutes) ...... 524
Amendments.
Total ...................................... ........................ ........................ ........................ ........................ .................................... 7,175
1There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: January 8, 2018. be submitted on or before March 12, • For written/paper comments
Leslie Kux, 2018. The https://www.regulations.gov submitted to the Dockets Management
Associate Commissioner for Policy. electronic filing system will accept Staff, FDA will post your comment, as
[FR Doc. 2018–00354 Filed 1–10–18; 8:45 am] comments until midnight Eastern Time well as any attachments, except for
BILLING CODE 4164–01–P at the end of March 12, 2018. Comments information submitted, marked and
received by mail/hand delivery/courier identified, as confidential, if submitted
(for written/paper submissions) will be as detailed in ‘‘Instructions.’’
DEPARTMENT OF HEALTH AND considered timely if they are Instructions: All submissions received
HUMAN SERVICES postmarked or the delivery service must include the Docket Nos. FDA–
acceptance receipt is on or before that 2016–E–3310 and FDA–2016–E–3341
Food and Drug Administration date. for ‘‘Determination of Regulatory
[Docket Nos. FDA–2016–E–3310 and FDA–
Review Period for Purposes of Patent
Electronic Submissions Extension; ENTYCE.’’ Received
2016–E–3341]
Submit electronic comments in the comments, those filed in a timely
Determination of Regulatory Review following way: manner (see ADDRESSES), will be placed
Period for Purposes of Patent • Federal eRulemaking Portal: in the docket and, except for those
Extension; ENTYCE https://www.regulations.gov. Follow the submitted as ‘‘Confidential
instructions for submitting comments. Submissions,’’ publicly viewable at
AGENCY: Food and Drug Administration, https://www.regulations.gov or at the
HHS. Comments submitted electronically,
Dockets Management Staff between 9
ACTION: Notice. including attachments, to https://
a.m. and 4 p.m., Monday through
www.regulations.gov will be posted to
SUMMARY: The Food and Drug Friday.
the docket unchanged. Because your • Confidential Submissions—To
Administration (FDA or the Agency) has comment will be made public, you are submit a comment with confidential
determined the regulatory review period solely responsible for ensuring that your information that you do not wish to be
for ENTYCE and is publishing this comment does not include any made publicly available, submit your
notice of that determination as required confidential information that you or a comments only as a written/paper
by law. FDA has made the third party may not wish to be posted, submission. You should submit two
determination because of the such as medical information, your or copies total. One copy will include the
submission of applications to the anyone else’s Social Security number, or information you claim to be confidential
Director of the U.S. Patent and confidential business information, such with a heading or cover note that states
Trademark Office (USPTO), Department as a manufacturing process. Please note ‘‘THIS DOCUMENT CONTAINS
of Commerce, for the extension of a that if you include your name, contact CONFIDENTIAL INFORMATION.’’ The
patent which claims that animal drug information, or other information that Agency will review this copy, including
product. identifies you in the body of your the claimed confidential information, in
DATES: Anyone with knowledge that any comments, that information will be its consideration of comments. The
of the dates as published (see the posted on https://www.regulations.gov. second copy, which will have the
SUPPLEMENTARY INFORMATION section) are • If you want to submit a comment claimed confidential information
incorrect may submit either electronic with confidential information that you redacted/blacked out, will be available
or written comments and ask for a do not wish to be made available to the for public viewing and posted on
redetermination by March 12, 2018. public, submit the comment as a https://www.regulations.gov. Submit
Furthermore, any interested person may written/paper submission and in the both copies to the Dockets Management
petition FDA for a determination manner detailed (see ‘‘Written/Paper Staff. If you do not wish your name and
regarding whether the applicant for Submissions’’ and ‘‘Instructions’’). contact information to be made publicly
extension acted with due diligence Written/Paper Submissions available, you can provide this
during the regulatory review period by information on the cover sheet and not
srobinson on DSK9F5VC42PROD with NOTICES
July 10, 2018. See ‘‘Petitions’’ in the Submit written/paper submissions as in the body of your comments and you
SUPPLEMENTARY INFORMATION section for follows: must identify this information as
more information. • Mail/Hand Delivery/Courier (for ‘‘confidential.’’ Any information marked
ADDRESSES: You may submit comments written/paper submissions): Dockets as ‘‘confidential’’ will not be disclosed
as follows. Please note that late, Management Staff (HFA–305), Food and except in accordance with § 10.20 (21
untimely filed comments will not be Drug Administration, 5630 Fishers CFR 10.20) and other applicable
considered. Electronic comments must Lane, Rm. 1061, Rockville, MD 20852. disclosure law. For more information
VerDate Sep<11>2014 00:05 Jan 11, 2018 Jkt 244001 PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 E:\FR\FM\11JAN1.SGM 11JAN1](https://thefederalregister.org/doc/83_FR_1371/page/3.svg)
Document Created: 2018-01-11 04:54:13
Document Modified: 2018-01-11 04:54:13
| 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 | Fax written comments on the collection of information by February 12, 2018. | |
| 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 1363 |
2024 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR