83 FR 23690 - Bioanalytical Method Validation; Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 99 (May 22, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 99 (May 22, 2018)
| Page Range | 23690-23691 | |
| FR Document | 2018-10926 |
[Federal Register Volume 83, Number 99 (Tuesday, May 22, 2018)] [Notices] [Pages 23690-23691] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-10926] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-D-1020] Bioanalytical Method Validation; 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 final guidance for industry entitled ``Bioanalytical Method Validation.'' This final guidance incorporates public comments to the revised draft published in 2013 as well as the latest scientific feedback concerning bioanalytical method validation and provides the most up-to-date information needed by drug developers to ensure the bioanalytical quality of their data. DATES: The announcement of the guidance is published in the Federal Register on May 22, 2018. ADDRESSES: You may submit either electronic or written comments on Agency guidances 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 [[Page 23691]] 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-2013-D-1020 for ``Bioanalytical Method Validation.'' 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. Confidential Submissions--To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ``confidential.'' Any information marked as ``confidential'' will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the 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. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). Submit written requests for single copies of this 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 Policy and Regulations Staff (HFV-6), Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. FOR FURTHER INFORMATION CONTACT: Brian Booth, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301-796-1508; or Olutosin (Remi) Idowu, Center for Veterinary Medicine, 7500 Standish Pl., Rockville, MD 20855, 240-402-0704. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a guidance for industry entitled ``Bioanalytical Method Validation.'' The guidance describes the elements of bioanalytical method development and validation that are needed to ensure the quality of an assay and the reliability of the data it generates. The concepts apply both to chromatographic assays as well as ligand-binding assays. This guidance incorporates the latest scientific practices in method validation, newer science on incurred sample reanalysis, the use of new analytical platforms, the repurposing of diagnostic kits for drug development, and general advice on bioanalytical method development and validation for biomarkers in drug development. This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on ``Bioanalytical Method Validation.'' 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. This guidance is not subject to Executive Order 12866. II. Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501- 3520). The collections of information in 21 CFR part 58 have been approved under OMB control number 0910-0119; the collections of information in 21 CFR part 312 have been approved under OMB control number 0910-0014; the collections of information in 21 CFR part 314 have been approved under OMB control number 0910-0001; the collections of information in 21 CFR part 514 have been approved under OMB control number 0910-0032; the collections of information in 21 CFR part 511 have been approved under OMB control number 0910-0117; and the collections of information in section 360b(n)(1) (21 U.S.C 512(n)(1)) of the Federal Food, Drug and Cosmetic Act have been approved in OMB control number 0910-0669. III. Electronic Access Persons with access to the internet may obtain the guidance at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov. Dated: May 17, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-10926 Filed 5-21-18; 8:45 am] BILLING CODE 4164-01-P
![23690 Federal Register / Vol. 83, No. 99 / Tuesday, May 22, 2018 / Notices
• If you want to submit a comment the information at: https://www.gpo.gov/ regulations. This guidance is not subject
with confidential information that you fdsys/pkg/FR-2015-09-18/pdf/2015- to Executive Order 12866.
do not wish to be made available to the 23389.pdf.
II. Electronic Access
public, submit the comment as a Docket: For access to the docket to
written/paper submission and in the read background documents or the Persons with access to the internet
manner detailed (see ‘‘Written/Paper electronic and written/paper comments may obtain the guidance at either
Submissions’’ and ‘‘Instructions’’). received, go to https:// https://www.fda.gov/Drugs/
www.regulations.gov and insert the GuidanceCompliance
Written/Paper Submissions
docket number, found in brackets in the RegulatoryInformation/Guidances/
Submit written/paper submissions as heading of this document, into the default.htm or https://
follows: ‘‘Search’’ box and follow the prompts www.regulations.gov.
• Mail/Hand delivery/Courier (for and/or go to the Dockets Management Dated: May 17, 2018.
written/paper submissions): Dockets Staff, 5630 Fishers Lane, Rm. 1061,
Management Staff (HFA–305), Food and Leslie Kux,
Rockville, MD 20852. Associate Commissioner for Policy.
Drug Administration, 5630 Fishers You may submit comments on any
Lane, Rm. 1061, Rockville, MD 20852. guidance at any time (see 21 CFR
[FR Doc. 2018–10928 Filed 5–21–18; 8:45 am]
• For written/paper comments 10.115(g)(5)). BILLING CODE 4164–01–P
submitted to the Dockets Management Submit written requests for single
Staff, FDA will post your comment, as copies of this guidance to the Division
well as any attachments, except for DEPARTMENT OF HEALTH AND
of Drug Information, Center for Drug
information submitted, marked and HUMAN SERVICES
Evaluation and Research, Food and
identified, as confidential, if submitted
Drug Administration, 10001 New Food and Drug Administration
as detailed in ‘‘Instructions.’’
Hampshire Ave., Hillandale Building,
Instructions: All submissions received [Docket No. FDA–2013–D–1020]
must include the Docket No. FDA– 4th Floor, Silver Spring, MD 20993–
2005–D–0461 for ‘‘Acne Vulgaris: 0002. Send one self-addressed adhesive
Bioanalytical Method Validation;
Establishing Effectiveness of Drugs label to assist that office in processing
Guidance for Industry; Availability
Intended for Treatment; Guidance for your requests. See the SUPPLEMENTARY
INFORMATION section for electronic AGENCY: Food and Drug Administration,
Industry.’’ Received comments will be
placed in the docket and, except for access to the guidance document. HHS.
those submitted as ‘‘Confidential FOR FURTHER INFORMATION CONTACT: ACTION: Notice of availability.
Submissions,’’ publicly viewable at Strother D. Dixon, Center for Drug
https://www.regulations.gov or at the Evaluation and Research, Food and SUMMARY: The Food and Drug
Dockets Management Staff between 9 Drug Administration, 10903 New Administration (FDA or Agency) is
a.m. and 4 p.m., Monday through Hampshire Ave., Bldg. 22, Rm. 5168, announcing the availability of a final
Friday. Silver Spring, MD 20993–0002, 301– guidance for industry entitled
• Confidential Submissions—To 796–1015. ‘‘Bioanalytical Method Validation.’’
submit a comment with confidential SUPPLEMENTARY INFORMATION:
This final guidance incorporates public
information that you do not wish to be comments to the revised draft published
made publicly available, submit your I. Background in 2013 as well as the latest scientific
comments only as a written/paper FDA is announcing the availability of feedback concerning bioanalytical
submission. You should submit two a guidance for industry entitled ‘‘Acne method validation and provides the
copies total. One copy will include the Vulgaris: Establishing Effectiveness of most up-to-date information needed by
information you claim to be confidential Drugs Intended for Treatment.’’ This drug developers to ensure the
with a heading or cover note that states guidance provides recommendations to bioanalytical quality of their data.
‘‘THIS DOCUMENT CONTAINS industry for establishing the clinical DATES: The announcement of the
CONFIDENTIAL INFORMATION.’’ The effectiveness of drugs for the treatment guidance is published in the Federal
Agency will review this copy, including of acne. This guidance finalizes the draft Register on May 22, 2018.
the claimed confidential information, in guidance for industry entitled ‘‘Acne ADDRESSES: You may submit either
its consideration of comments. The Vulgaris: Developing Drugs for electronic or written comments on
second copy, which will have the Treatment,’’ issued September 19, 2005 Agency guidances at any time as
claimed confidential information (70 FR 54945). Comments on the draft follows:
redacted/blacked out, will be available guidance were considered while
for public viewing and posted on finalizing this guidance. Changes made Electronic Submissions
https://www.regulations.gov. Submit to the draft guidance include Submit electronic comments in the
both copies to the Dockets Management reformatting into a bulleted presentation following way:
Staff. If you do not wish your name and and streamlining of information to core • Federal eRulemaking Portal:
contact information to be made publicly recommendations. https://www.regulations.gov. Follow the
available, you can provide this This guidance is being issued instructions for submitting comments.
information on the cover sheet and not consistent with FDA’s good guidance Comments submitted electronically,
in the body of your comments and you practices regulation (21 CFR 10.115). including attachments, to https://
must identify this information as The guidance represents the current www.regulations.gov will be posted to
amozie on DSK3GDR082PROD with NOTICES1
‘‘confidential.’’ Any information marked thinking of FDA on establishing the the docket unchanged. Because your
as ‘‘confidential’’ will not be disclosed effectiveness of drugs intended to treat comment will be made public, you are
except in accordance with 21 CFR 10.20 acne. It does not establish any rights for solely responsible for ensuring that your
and other applicable disclosure law. For any person and is not binding on FDA comment does not include any
more information about FDA’s posting or the public. You can use an alternative confidential information that you or a
of comments to public dockets, see 80 approach if it satisfies the requirements third party may not wish to be posted,
FR 56469, September 18, 2015, or access of the applicable statutes and such as medical information, your or
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![Federal Register / Vol. 83, No. 99 / Tuesday, May 22, 2018 / Notices 23691
anyone else’s Social Security number, or in the body of your comments and you guidance incorporates the latest
confidential business information, such must identify this information as scientific practices in method
as a manufacturing process. Please note ‘‘confidential.’’ Any information marked validation, newer science on incurred
that if you include your name, contact as ‘‘confidential’’ will not be disclosed sample reanalysis, the use of new
information, or other information that except in accordance with 21 CFR 10.20 analytical platforms, the repurposing of
identifies you in the body of your and other applicable disclosure law. For diagnostic kits for drug development,
comments, that information will be more information about FDA’s posting and general advice on bioanalytical
posted on https://www.regulations.gov. of comments to public dockets, see 80 method development and validation for
• If you want to submit a comment FR 56469, September 18, 2015, or access biomarkers in drug development.
with confidential information that you the information at: https://www.gpo.gov/
This guidance is being issued
do not wish to be made available to the fdsys/pkg/FR-2015-09-18/pdf/2015-
public, submit the comment as a consistent with FDA’s good guidance
23389.pdf.
written/paper submission and in the Docket: For access to the docket to practices regulation (21 CFR 10.115).
manner detailed (see ‘‘Written/Paper read background documents or the The guidance represents the current
Submissions’’ and ‘‘Instructions’’). electronic and written/paper comments thinking of FDA on ‘‘Bioanalytical
received, go to https:// Method Validation.’’ It does not
Written/Paper Submissions establish any rights for any person and
www.regulations.gov and insert the
Submit written/paper submissions as docket number, found in brackets in the is not binding on FDA or the public.
follows: heading of this document, into the You can use an alternative approach if
• Mail/Hand delivery/Courier (for ‘‘Search’’ box and follow the prompts it satisfies the requirements of the
written/paper submissions): Dockets and/or go to the Dockets Management applicable statutes and regulations. This
Management Staff (HFA–305), Food and Staff, 5630 Fishers Lane, Rm. 1061, guidance is not subject to Executive
Drug Administration, 5630 Fishers Rockville, MD 20852. Order 12866.
Lane, Rm. 1061, Rockville, MD 20852. You may submit comments on any II. Paperwork Reduction Act of 1995
• For written/paper comments guidance at any time (see 21 CFR
submitted to the Dockets Management 10.115(g)(5)). This guidance refers to previously
Staff, FDA will post your comment, as Submit written requests for single approved collections of information that
well as any attachments, except for copies of this guidance to the Division are subject to review by the Office of
information submitted, marked and of Drug Information, Center for Drug Management and Budget (OMB) under
identified, as confidential, if submitted Evaluation and Research, Food and the Paperwork Reduction Act of 1995
as detailed in ‘‘Instructions.’’ Drug Administration, 10001 New (44 U.S.C. 3501–3520). The collections
Instructions: All submissions received Hampshire Ave., Hillandale Building, of information in 21 CFR part 58 have
must include the Docket No. FDA– 4th Floor, Silver Spring, MD 20993– been approved under OMB control
2013–D–1020 for ‘‘Bioanalytical Method 0002; or Policy and Regulations Staff number 0910–0119; the collections of
Validation.’’ Received comments will be (HFV–6), Center for Veterinary information in 21 CFR part 312 have
placed in the docket and, except for Medicine, Food and Drug been approved under OMB control
those submitted as ‘‘Confidential Administration, 7500 Standish Pl., number 0910–0014; the collections of
Submissions,’’ publicly viewable at Rockville, MD 20855. Send one self- information in 21 CFR part 314 have
https://www.regulations.gov or at the addressed adhesive label to assist that been approved under OMB control
Dockets Management Staff between 9 office in processing your requests. See number 0910–0001; the collections of
a.m. and 4 p.m., Monday through the SUPPLEMENTARY INFORMATION section information in 21 CFR part 514 have
Friday. for electronic access to the guidance been approved under OMB control
• Confidential Submissions—To document. number 0910–0032; the collections of
submit a comment with confidential information in 21 CFR part 511 have
information that you do not wish to be FOR FURTHER INFORMATION CONTACT:
Brian Booth, Center for Drug Evaluation been approved under OMB control
made publicly available, submit your
and Research, Food and Drug number 0910–0117; and the collections
comments only as a written/paper
Administration, 10903 New Hampshire of information in section 360b(n)(1) (21
submission. You should submit two
Ave., Silver Spring, MD 20993, 301– U.S.C 512(n)(1)) of the Federal Food,
copies total. One copy will include the
796–1508; or Olutosin (Remi) Idowu, Drug and Cosmetic Act have been
information you claim to be confidential
Center for Veterinary Medicine, 7500 approved in OMB control number 0910–
with a heading or cover note that states
Standish Pl., Rockville, MD 20855, 240– 0669.
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The 402–0704. III. Electronic Access
Agency will review this copy, including SUPPLEMENTARY INFORMATION:
the claimed confidential information, in Persons with access to the internet
its consideration of comments. The I. Background may obtain the guidance at either
second copy, which will have the FDA is announcing the availability of https://www.fda.gov/Drugs/Guidance
claimed confidential information a guidance for industry entitled ComplianceRegulatoryInformation/
redacted/blacked out, will be available ‘‘Bioanalytical Method Validation.’’ The Guidances/default.htm or https://
for public viewing and posted on guidance describes the elements of www.regulations.gov.
https://www.regulations.gov. Submit bioanalytical method development and
amozie on DSK3GDR082PROD with NOTICES1
Dated: May 17, 2018.
both copies to the Dockets Management validation that are needed to ensure the
Leslie Kux,
Staff. If you do not wish your name and quality of an assay and the reliability of
contact information to be made publicly the data it generates. The concepts Associate Commissioner for Policy.
available, you can provide this apply both to chromatographic assays as [FR Doc. 2018–10926 Filed 5–21–18; 8:45 am]
information on the cover sheet and not well as ligand-binding assays. This BILLING CODE 4164–01–P
VerDate Sep<11>2014 16:47 May 21, 2018 Jkt 241001 PO 00000 Frm 00067 Fmt 4703 Sfmt 4703 E:\FR\FM\22MYN1.SGM 22MYN1](https://thefederalregister.org/doc/83_FR_23789/page/2.svg)
Document Created: 2018-11-02 11:09:51
Document Modified: 2018-11-02 11:09:51
| 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 of availability. | |
| Dates | The announcement of the guidance is published in the Federal Register on May 22, 2018. | |
| Contact | Brian Booth, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301-796-1508; or Olutosin (Remi) Idowu, Center for Veterinary Medicine, 7500 Standish Pl., Rockville, MD 20855, 240-402-0704. | |
| FR Citation | 83 FR 23690 |
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