Data Standards for Drug and Biological Product Submissions Containing Real-World Data; Draft Guidance for Industry; Availability, 58672-58674 [2021-23081]

Download as PDF 58672 Federal Register / Vol. 86, No. 202 / Friday, October 22, 2021 / Notices lotter on DSK11XQN23PROD with NOTICES1 NUBEQA is 2,576 days. Of this time, 2,420 days occurred during the testing phase of the regulatory review period, while 156 days occurred during the approval phase. These periods of time were derived from the following dates: 1. The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(i)) became effective: July 13, 2012. FDA has verified the applicant’s claim that the date the investigational new drug application became effective was on July 13, 2012. 2. The date the application was initially submitted with respect to the human drug product under section 505 of the FD&C Act: February 26, 2019. FDA has verified the applicant’s claim that the new drug application (NDA) for NUBEQA (NDA 212099) was initially submitted on February 26, 2019. 3. The date the application was approved: July 30, 2019. FDA has verified the applicant’s claim that NDA 212099 was approved on July 30, 2019. This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 879 days of patent term extension. III. Petitions Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and, under 21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as specified in § 60.30 (21 CFR 60.30), any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period. To meet its burden, the petition must comply with all the requirements of § 60.30, including but not limited to: must be timely (see DATES), must be filed in accordance with § 10.20, must contain sufficient facts to merit an FDA investigation, and must certify that a true and complete copy of the petition has been served upon the patent applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41–42, 1984.) Petitions should be in the format specified in 21 CFR 10.30. Submit petitions electronically to https://www.regulations.gov at Docket No. FDA–2013–S–0610. Submit written petitions (two copies are required) to the Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. VerDate Sep<11>2014 17:47 Oct 21, 2021 Jkt 256001 Dated: October 15, 2021. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2021–23074 Filed 10–21–21; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2021–D–0548] Data Standards for Drug and Biological Product Submissions Containing RealWorld Data; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ‘‘Data Standards for Drug and Biological Product Submissions Containing RealWorld Data.’’ This guidance provides recommendations to sponsors to help support compliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act) when submitting study data derived from real-world data (RWD) sources in applicable regulatory submissions using standards specified in the Data Standards Catalog (Catalog). FDA is publishing this draft guidance as part of a series of guidance documents under its program to evaluate the use of real-world evidence (RWE) in regulatory decision making. DATES: Submit either electronic or written comments on the draft guidance by December 21, 2021 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. ADDRESSES: You may submit comments on any guidance at any time as follows: SUMMARY: 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 PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 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– 2021–D–0548 for ‘‘Data Standards for Drug and Biological Product Submissions Containing Real-World Data.’’ Received comments 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, 240–402–7500. • 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 E:\FR\FM\22OCN1.SGM 22OCN1 Federal Register / Vol. 86, No. 202 / Friday, October 22, 2021 / Notices 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.govinfo.gov/content/pkg/FR-201509-18/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, 240–402–7500. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993– 0002, or the Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993–0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. FOR FURTHER INFORMATION CONTACT: Dianne Paraoan, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave, Bldg. 51, Rm. 3326, Silver Spring, MD 20993–0002, 301– 796–3161, Dianne.Paraoan@ fda.hhs.gov, or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, Bldg. 71, Rm. 7301, Silver Spring, MD 20993– 0002, 240–402–7911. SUPPLEMENTARY INFORMATION: lotter on DSK11XQN23PROD with NOTICES1 I. Background FDA is announcing the availability of a draft guidance for industry entitled ‘‘Data Standards for Drug and Biological Product Submissions Containing RealWorld Data.’’ Under section 745A(a) of the FD&C Act (21 U.S.C. 379k–1(a)) and the guidance for industry entitled ‘‘Providing Regulatory Submissions in Electronic Format—Standardized Study Data’’ (Study Data Guidance), clinical or nonclinical study data contained in new drug applications (NDAs), abbreviated VerDate Sep<11>2014 17:47 Oct 21, 2021 Jkt 256001 new drug applications (ANDAs), certain biologics license applications (BLAs), and certain investigational new drug applications (INDs) must be in an electronic format that the Agency can process, review, and archive, unless such submission is exempt from the electronic submission requirements or if FDA has granted a waiver. This guidance clarifies that RWD submitted as study data in NDAs, ANDAs, certain BLAs, and certain INDs are subject to the requirements in section 745A(a) of the FD&C Act (21 U.S.C. 379k–1(a)) and the Study Data Guidance. Currently, as stated in the Study Data Guidance, the Agency can process, review, and archive electronic submissions of clinical and nonclinical study data (including data derived from RWD sources) that use the standards specified in the Catalog posted to FDA’s Study Data Standards Resources web page (https:// www.fda.gov/industry/fda-resourcesdata-standards/study-data-standardsresources). Therefore, submissions subject to section 745A(a) of the FD&C Act that contain study data derived from RWD sources must be in electronic format using the study data standards currently supported by FDA as specified in the Catalog. This guidance provides recommendations to sponsors for complying with section 745A(a) of the FD&C Act when submitting study data derived from RWD sources in an applicable regulatory submission using standards specified in the Catalog. Section 3022 of the 21st Century Cures Act (Cures Act) amended the FD&C Act to add section 505F, Utilizing Real World Evidence (21 U.S.C. 355g). This section requires the establishment of a program to evaluate the potential use of RWE to help support the approval of a new indication for a drug approved under section 505(c) of the FD&C Act (21 U.S.C. 355(c)) and to help support or satisfy postapproval study requirements. This section also requires that FDA use the program to inform guidance for industry on the circumstances under which sponsors of drugs may rely on RWE and the appropriate standards and methodologies for collection and analysis of RWE submitted to evaluate the potential use of RWE for those purposes. Further, under the Prescription Drug User Fee Amendments of 2017 (PDUFA VI), FDA committed to publishing draft guidance on how RWE can contribute to the assessment of safety and effectiveness in regulatory submissions. FDA is issuing the draft guidance entitled ‘‘Data Standards for Drug and Biological Product Submissions Containing Real- PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 58673 World Data’’ as part of a series of guidance documents to satisfy the Cures Act mandate and the PDUFA VI commitment. 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 current thinking of FDA on ‘‘Data Standards for Drug and Biological Product Submissions Containing Real-World Data.’’ It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. II. Paperwork Reduction Act of 1995 While this guidance contains no collection of information, it does refer to previously approved FDA collections of information. Therefore, clearance by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501– 3521) is not required for this guidance. The previously approved collections of information are subject to review by OMB under the PRA. The collections of information in 21 CFR part 314 (Applications for FDA Approval to Market a New Drug) have been approved under OMB control number 0910–0001; the collections of information in 21 CFR part 312 (Investigational New Drug Regulations) have been approved under OMB control number 0910–0014; the collections of information in 21 CFR part 58 (Good Laboratory Practice Regulations for Nonclinical Laboratory Studies) have been approved under OMB control number 0910–0119; and the collections of information in 21 CFR part 601 (General Licensing Provisions: Biologics License Application, Changes to an Approved Application, Labeling, Revocation and Suspension) have been approved under OMB control number 0910–0338. III. Electronic Access Persons with access to the internet may obtain the draft guidance at https:// www.fda.gov/regulatory-information/ search-fda-guidance-documents, https://www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm, https:// www.fda.gov/vaccines-blood-biologics/ guidance-compliance-regulatoryinformation-biologics/biologicsguidances, or https:// www.regulations.gov. E:\FR\FM\22OCN1.SGM 22OCN1 58674 Federal Register / Vol. 86, No. 202 / Friday, October 22, 2021 / Notices Dated: October 8, 2021. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2021–23081 Filed 10–21–21; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2021–N–1038] Determination That ROBAXIN and ROBAXIN–750 (Methocarbamol), Oral Tablets, 500 Milligrams and 750 Milligrams, and Other Drug Products, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or Agency) has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that lotter on DSK11XQN23PROD with NOTICES1 SUMMARY: refer to the products as long as they meet relevant legal and regulatory requirements. FOR FURTHER INFORMATION CONTACT: Stacy Kane, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6236, Silver Spring, MD 20993–0002, 301–796–8363, Stacy.Kane@fda.hhs.gov. SUPPLEMENTARY INFORMATION: Section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)) allows the submission of an ANDA to market a generic version of a previously approved drug product. To obtain approval, the ANDA applicant must show, among other things, that the generic drug product: (1) Has the same active ingredient(s), dosage form, route of administration, strength, conditions of use, and (with certain exceptions) labeling as the listed drug, which is a version of the drug that was previously approved and (2) is bioequivalent to the listed drug. ANDA applicants do not have to repeat the extensive clinical testing otherwise necessary to gain approval of a new drug application (NDA). Section 505(j)(7) of the FD&C Act requires FDA to publish a list of all approved drugs. FDA publishes this list as part of the ‘‘Approved Drug Products With Therapeutic Equivalence Evaluations,’’ which is generally known as the ‘‘Orange Book.’’ Under FDA regulations, a drug is removed from the list if the Agency withdraws or suspends approval of the drug’s NDA or ANDA for reasons of safety or effectiveness, or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162). Under § 314.161(a) (21 CFR 314.161(a)), the Agency must determine whether a listed drug was withdrawn from sale for reasons of safety or effectiveness: (1) Before an ANDA that refers to that listed drug may be approved, (2) whenever a listed drug is voluntarily withdrawn from sale and ANDAs that refer to the listed drug have been approved, and (3) when a person petitions for such a determination under 21 CFR 10.25(a) and 10.30. Section 314.161(d) provides that if FDA determines that a listed drug was withdrawn from sale for safety or effectiveness reasons, the Agency will initiate proceedings that could result in the withdrawal of approval of the ANDAs that refer to the listed drug. FDA has become aware that the drug products listed in the table are no longer being marketed. Application No. Drug name Active ingredient(s) Strength(s) Dosage form/route Applicant NDA 011011 ... Methocarbamol ........... Auxilium Pharmaceuticals LLC. Novartis. Promius Pharma, LLC. NDA 019546 ... NDA 019555 ... DYNACIRC .................. DIPROLENE AF .......... NDA 019625 ... NDA 020089 ... NDA 020136 ... ELOCON ..................... ZOVIRAX .................... DEMADEX .................. Isradipine ..................... Betamethasone Dipropionate. Mometasone Furoate .. Acyclovir ...................... Torsemide ................... 500 milligrams (mg); 750 mg. 1 mg/milliliter (mL) ....... Equivalent to (EQ) 200 mg base; EQ 400 mg base. 2.5 mg; 5 mg ............... EQ 0.05% base ........... Tablet; Oral ................. NDA 018704 ... NDA 018917 ... ROBAXIN; ROBAXIN– 750. LOPRESSOR .............. SECTRAL .................... NDA 020198 ... ADALAT CC ................ Nifedipine .................... NDA 020539 ... LAMISIL ...................... NDA 020634 ... LEVAQUIN .................. Terbinafine Hydrochloride. Levofloxacin ................ NDA 020716 ... VICOPROFEN ............. NDA 020738 ... TEVETEN .................... Hydrocodone Bitartrate; Ibuprofen. Eprosartan Mesylate ... NDA 021001 ... AXERT ........................ Almotriptan Malate ...... NDA 022205 ... GIAZO ......................... Balsalazide Disodium .. NDA 022439 ... ZUTRIPRO .................. Chlorpheniramine Maleate, Hydrocodone Bitartrate, and Pseudoephedrine Hydrochloride. VerDate Sep<11>2014 17:47 Oct 21, 2021 Jkt 256001 Metoprolol Tartrate ...... Acebutolol Hydrochloride. PO 00000 Frm 00039 Injectable; Injection ..... Capsule; Oral .............. Capsule; Oral .............. Cream, Augmented; Topical. Cream; Topical ............ Tablet; Oral ................. Tablet; Oral ................. SmithKline Beecham. Merck Sharp Dohme. Tablet, Extended Release; Oral. Tablet; Oral ................. Alvogen. 250 mg; 500 mg; 750 mg. 7.5 mg; 200 mg ........... Tablet; Oral ................. Tablet; Oral ................. Janssen Research & Development, LLC. Abbvie, Inc. EQ 300 mg base; EQ 400 mg base; EQ 600 mg base. EQ 6.25 mg base; EQ 12.5 mg base. 1.1 gram ...................... Tablet; Oral ................. Abbvie, Inc. Tablet; Oral ................. Janssen Pharms. Tablets; Oral ............... 4 mg/5 mL; 5 mg/5 mL; 60 mg/5 mL. Solution; Oral .............. Valeant Pharms. International. Persion Pharms, LLC. 0.10% .......................... 400 mg; 800 mg .......... 5 mg; 10 mg; 20 mg; 100 mg. 30 mg; 60 mg; 90 mg EQ 250 mg base ......... Fmt 4703 Sfmt 4703 E:\FR\FM\22OCN1.SGM 22OCN1 Merck Sharp Dohme. Mylan. Mylan Specialty, L.P. Novartis.

Agencies

[Federal Register Volume 86, Number 202 (Friday, October 22, 2021)]
[Notices]
[Pages 58672-58674]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-23081]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-D-0548]


Data Standards for Drug and Biological Product Submissions 
Containing Real-World Data; Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a draft guidance for industry entitled ``Data 
Standards for Drug and Biological Product Submissions Containing Real-
World Data.'' This guidance provides recommendations to sponsors to 
help support compliance with the Federal Food, Drug, and Cosmetic Act 
(FD&C Act) when submitting study data derived from real-world data 
(RWD) sources in applicable regulatory submissions using standards 
specified in the Data Standards Catalog (Catalog). FDA is publishing 
this draft guidance as part of a series of guidance documents under its 
program to evaluate the use of real-world evidence (RWE) in regulatory 
decision making.

DATES: Submit either electronic or written comments on the draft 
guidance by December 21, 2021 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as 
follows:

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-2021-D-0548 for ``Data Standards for Drug and Biological Product 
Submissions Containing Real-World Data.'' Received comments 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, 240-402-7500.
     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

[[Page 58673]]

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.govinfo.gov/content/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, 240-402-7500.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to 
the Division of Drug Information, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10001 New Hampshire Ave., 
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002, or the 
Office of Communication, Outreach and Development, Center for Biologics 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send 
one self-addressed adhesive label to assist that office in processing 
your requests. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Dianne Paraoan, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave, Bldg. 51, Rm. 3326, Silver Spring, MD 20993-0002, 301-
796-3161, [email protected], or Stephen Ripley, Center for 
Biologics Evaluation and Research, Food and Drug Administration, Bldg. 
71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Data Standards for Drug and Biological Product Submissions 
Containing Real-World Data.'' Under section 745A(a) of the FD&C Act (21 
U.S.C. 379k-1(a)) and the guidance for industry entitled ``Providing 
Regulatory Submissions in Electronic Format--Standardized Study Data'' 
(Study Data Guidance), clinical or nonclinical study data contained in 
new drug applications (NDAs), abbreviated new drug applications 
(ANDAs), certain biologics license applications (BLAs), and certain 
investigational new drug applications (INDs) must be in an electronic 
format that the Agency can process, review, and archive, unless such 
submission is exempt from the electronic submission requirements or if 
FDA has granted a waiver. This guidance clarifies that RWD submitted as 
study data in NDAs, ANDAs, certain BLAs, and certain INDs are subject 
to the requirements in section 745A(a) of the FD&C Act (21 U.S.C. 379k-
1(a)) and the Study Data Guidance. Currently, as stated in the Study 
Data Guidance, the Agency can process, review, and archive electronic 
submissions of clinical and nonclinical study data (including data 
derived from RWD sources) that use the standards specified in the 
Catalog posted to FDA's Study Data Standards Resources web page 
(https://www.fda.gov/industry/fda-resources-data-standards/study-data-standards-resources). Therefore, submissions subject to section 745A(a) 
of the FD&C Act that contain study data derived from RWD sources must 
be in electronic format using the study data standards currently 
supported by FDA as specified in the Catalog. This guidance provides 
recommendations to sponsors for complying with section 745A(a) of the 
FD&C Act when submitting study data derived from RWD sources in an 
applicable regulatory submission using standards specified in the 
Catalog.
    Section 3022 of the 21st Century Cures Act (Cures Act) amended the 
FD&C Act to add section 505F, Utilizing Real World Evidence (21 U.S.C. 
355g). This section requires the establishment of a program to evaluate 
the potential use of RWE to help support the approval of a new 
indication for a drug approved under section 505(c) of the FD&C Act (21 
U.S.C. 355(c)) and to help support or satisfy postapproval study 
requirements. This section also requires that FDA use the program to 
inform guidance for industry on the circumstances under which sponsors 
of drugs may rely on RWE and the appropriate standards and 
methodologies for collection and analysis of RWE submitted to evaluate 
the potential use of RWE for those purposes. Further, under the 
Prescription Drug User Fee Amendments of 2017 (PDUFA VI), FDA committed 
to publishing draft guidance on how RWE can contribute to the 
assessment of safety and effectiveness in regulatory submissions. FDA 
is issuing the draft guidance entitled ``Data Standards for Drug and 
Biological Product Submissions Containing Real-World Data'' as part of 
a series of guidance documents to satisfy the Cures Act mandate and the 
PDUFA VI commitment.
    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 current thinking of FDA on ``Data 
Standards for Drug and Biological Product Submissions Containing Real-
World Data.'' It does not establish any rights for any person and is 
not binding on FDA or the public. You can use an alternative approach 
if it satisfies the requirements of the applicable statutes and 
regulations.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does 
refer to previously approved FDA collections of information. Therefore, 
clearance by the Office of Management and Budget (OMB) under the 
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not 
required for this guidance. The previously approved collections of 
information are subject to review by OMB under the PRA. The collections 
of information in 21 CFR part 314 (Applications for FDA Approval to 
Market a New Drug) have been approved under OMB control number 0910-
0001; the collections of information in 21 CFR part 312 
(Investigational New Drug Regulations) have been approved under OMB 
control number 0910-0014; the collections of information in 21 CFR part 
58 (Good Laboratory Practice Regulations for Nonclinical Laboratory 
Studies) have been approved under OMB control number 0910-0119; and the 
collections of information in 21 CFR part 601 (General Licensing 
Provisions: Biologics License Application, Changes to an Approved 
Application, Labeling, Revocation and Suspension) have been approved 
under OMB control number 0910-0338.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance 
at https://www.fda.gov/regulatory-information/search-fda-guidance-documents, https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, or https://www.regulations.gov.


[[Page 58674]]


    Dated: October 8, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-23081 Filed 10-21-21; 8:45 am]
BILLING CODE 4164-01-P

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