Quiero saber acerca de...

lotter on DSK11XQN23PROD with NOTICES1

Federal Register / Vol. 86, No. 172 / Thursday, September 9, 2021 / Notices 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 FDAs 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, 2404027500.
You may submit comments on any guidance at any time see 21 CFR
10.115g5.
Submit written requests for single copies of this draft guidance to the Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research CBER, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 209930002, or 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. Send one self-addressed adhesive label to assist that office in processing your requests. The draft guidance may also be obtained by mail by calling CBER at 18008354709 or 240402
8010. See the SUPPLEMENTARY
INFORMATION section for electronic access to the guidance document.
FOR FURTHER INFORMATION CONTACT:
Regarding the guidance: Stephen Ripley, Center for Biologics Evaluation
VerDate Sep<11>2014

19:38 Sep 08, 2021

Jkt 253001

and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 209930002, 2404027911.
Regarding the ICH: Jill Adleberg, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6364, Silver Spring, MD 209930002, 3017965259, Jill.Adleberg@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background FDA is announcing the availability of a draft guidance for industry entitled S12 Nonclinical Biodistribution Considerations for Gene Therapy Products. The draft guidance was prepared under the auspices of ICH. ICH
has the mission of achieving greater regulatory harmonization worldwide to ensure that safe, effective, high-quality medicines are developed, registered, and maintained in the most resourceefficient manner.
By harmonizing the regulatory requirements in regions around the world, ICH guidelines have substantially reduced duplicative clinical studies, prevented unnecessary animal studies, standardized the reporting of important safety information, standardized marketing application submissions, and made many other improvements in the quality of global drug development and manufacturing and the products available to patients.
The six Founding Members of the ICH
are FDA; the Pharmaceutical Research and Manufacturers of America; the European Commission; the European Federation of Pharmaceutical Industries Associations; the Japanese Ministry of Health, Labour, and Welfare; and the Japanese Pharmaceutical Manufacturers Association. The Standing Members of the ICH Association include Health Canada and Swissmedic. Additionally, the Membership of ICH has expanded to include other regulatory authorities and industry associations from around the world refer to https www.ich.org/.
ICH works by involving technical experts from both regulators and industry parties in detailed technical harmonization work and the application of a science-based approach to harmonization through a consensusdriven process that results in the development of ICH guidelines. The regulators around the world are committed to consistently adopting these consensus-based guidelines, realizing the benefits for patients and for industry.
As a Founding Regulatory Member of ICH, FDA plays a major role in the
PO 00000

Frm 00014

Fmt 4703

Sfmt 4703

50537

development of each of the ICH
guidelines, which FDA then adopts and issues as guidance for industry. FDAs guidance documents do not establish legally enforceable responsibilities.
Instead, they describe the Agencys current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.
In June 2021, the ICH Assembly endorsed the draft guideline entitled S12 Nonclinical Biodistribution Considerations for Gene Therapy Products and agreed that the guidance should be made available for public comment. The draft guidance is the product of the Safety Expert Working Group of the ICH. Comments about this draft guidance will be considered by FDA and the Safety Expert Working Group.
FDA is thus announcing the availability of a draft guidance for industry entitled S12 Nonclinical Biodistribution Considerations for Gene Therapy Products. The draft guidance discusses the definition of BD and gives examples of GT products that are within the scope of the document. The guidance also provides recommendations for the design of nonclinical BD studies, such as the test article and dose levels administered, the animal species tested, route of administration, biofluid and tissue collection procedure, and other design elements. In addition, specific considerations, such as BD assay methods, GT expression product levels, and product immunogenicity are provided. The recommendations in the draft guidance are intended to promote harmonization in the development of a nonclinical development program for GT products to support clinical trial design, and reduce the use of animals, in accordance with the 3Rs reduce/
refine/replace principles.
This draft guidance has been left in the original ICH format. The final guidance will be reformatted and edited to conform with FDAs good guidance practices regulation 21 CFR 10.115 and style before publication. The draft guidance, when finalized, will represent the current thinking of FDA on S12
Nonclinical Biodistribution Considerations for Gene Therapy Products. 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
E:FRFM09SEN1.SGM

09SEN1