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Federal Register / Vol. 86, No. 171 / Wednesday, September 8, 2021 / Notices
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In addition, for evaluation of novel excipients with a proposed use in formulations for biological drug products reviewed by CDER/OND, submitters should provide:
Stability studies of the excipient under storage and potential in-use conditions e.g., over infusion time.
Novel excipients should be evaluated for their potential to prevent denaturation and degradation of proteins during storage.
For some excipients, studies should address their potential protein-excipient interaction and impact on drug product immunogenicity as well as their potential for masking process related impurities.
Full packages should be submitted through a Type V DMF or other master file no later than 3 months after notification that FDA has selected the proposal. For more information on submitting Type V DMFs, see the FDA
draft guidance for industry entitled Drug Master Files Ref. 8.
FDA will evaluate the full package and determine whether the excipient is appropriate for the proposed use for use in clinical trials. FDA will issue a letter to the novel excipient submitter announcing its decision.
For each novel excipient evaluated under the second stage of the program, FDA will publish on the Pilot Program web page the initial proposal and the determination letter. Information that cannot be publicly disclosed will be redacted. This web page will also include a content outline identifying information that should be included in an Initial Proposal and other relevant information regarding the pilot.
3. Effect of Determination A determination that the excipient is appropriate for use in clinical trials means that FDA has determined it is appropriate to use the novel excipient in an IND within the defined use without additional justification. However, the drug sponsor would still need to demonstrate that the excipient is safe in the proposed formulation. The information submitted under the full package would remain in the Type V
DMF or other master file, and the master file holder may grant authorization to reference the information in the master file at the holders discretion. Moreover, we do not anticipate that a novel excipient may be used in an abbreviated new drug application because data and information currently required to support use of a novel excipient may not be submitted in an abbreviated new drug application. After it has been used in approved drug products, the novel excipient would be added to the
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Inactive Ingredient Database in accordance with Agency practice.
If FDA determines that the excipient is not appropriate for the proposed use, an IND sponsor would be expected to provide additional information to demonstrate that the use of the novel excipient is appropriate within the context of the IND.
II. Paperwork Reduction Act of 1995
The information collection activities associated with the Pilot Program 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 Pilot Program. The previously approved collections of information are subject to review by OMB under the PRA. The collections of information in 21 CFR
part 314 pertaining to the submission of abbreviated new drug applications, new drug applications, and DMFs have been approved under OMB control number 09100001. The collections of information in 21 CFR part 312
pertaining to the submission of IND
content and format; chemistry, control, and manufacturing data; pharmacology and toxicology data; and pharmacokinetics and biological data have been approved under OMB control number 09100014. The collections of information in 21 CFR part 58
pertaining to good laboratory practice regulations for nonclinical laboratory studies have been approved under OMB
control number 09100119. The collections of information in 21 CFR
part 601 pertaining to biologics license applications have been approved under OMB control number 09100338.
III. References The following references are on display at the Dockets Management Staff HFA305, Food and Drug Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852, 240402
7500, and are available for viewing by interested persons between 9 a.m. and 4
p.m., Monday through Friday; they are also available electronically at https
www.regulations.gov. FDA has verified the website addresses, as of the date this document publishes in the Federal Register, but websites are subject to change over time.
1. FDA, Guidance for Industry, Nonclinical Studies for the Safety Evaluation of Pharmaceutical Excipients, May 2005
available at https www.fda.gov/media/
72260/download. For the most recent version of a guidance, check the FDA
guidance web page at https
www.fda.gov/regulatory-information/

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2. FDA Guidance for Industry, S7A Safety Pharmacology Studies for Human Pharmaceuticals, July 2001 available at https www.fda.gov/media/72033/
download.
3. FDA, Guidance for Industry, M3R2
Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals, January 2010
available at https www.fda.gov/media/
71542/download.
4. FDA, Guidance for Industry, S2B
Genotoxicity: A Standard Battery for Genotoxicity Testing of Pharmaceuticals, July 1997 available at https www.fda.gov/media/71971/
download.
5. International Council for Harmonization ICH, Guidance for Industry, Detection of Reproductive and Developmental Toxicity for Human Pharmaceuticals S5R3, February 2020 available at https database.ich.org/sites/default/
files/S5-R3_Step4_Guideline_2020_
0218_1.pdf.
6. FDA, Guidance for Industry, The Need for Long-term Rodent Carcinogenicity Studies of Pharmaceuticals, March 1996
available at https www.fda.gov/media/
71921/download.
7. FDA, Guidance for Industry, S8
Immunotoxicity Studies for Human Pharmaceuticals, April 2006 available at https www.fda.gov/media/72047/
download.
8. FDA, Draft Guidance for Industry Drug Master Files, October 2019 available at https www.fda.gov/media/131861/
download.
Dated: September 1, 2021.
Lauren K. Roth, Acting Principal Associate Commissioner for Policy.
FR Doc. 202119335 Filed 9721; 8:45 am BILLING CODE 416401P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services Administration Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: MCH
Jurisdictional Survey Instrument for the Title V MCH Block Grant Program, OMB No. 09060042, Extension Health Resources and Services Administration HRSA, Department of Health and Human Services.
ACTION: Notice.
AGENCY:

In compliance with the requirement of the Paperwork Reduction Act of 1995 for opportunity for public comment on proposed data collection projects, HRSA announces
SUMMARY:

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