82 FR 60019 - Drug Products, Including Biological Products, That Contain Nanomaterials; Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 241 (December 18, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 241 (December 18, 2017)
| Page Range | 60019-60021 | |
| FR Document | 2017-27133 |
[Federal Register Volume 82, Number 241 (Monday, December 18, 2017)] [Notices] [Pages 60019-60021] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-27133] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-D-0759] Drug Products, Including Biological Products, That Contain Nanomaterials; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS.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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Drug Products, Including Biological Products, that Contain Nanomaterials.'' This draft guidance has been developed to provide industry with the Agency's current thinking for the development of human drug products, including those that are biological products, that contain nanomaterials. The draft guidance also includes recommendations for applicants and sponsors of investigational, premarket, and postmarket submissions for these products. DATES: Submit either electronic or written comments on the draft guidance by March 19, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.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-2017-D-0759 for ``Drug Products, Including Biological Products, that Contain Nanomaterials.'' 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 [[Page 60020]] ``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 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. 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: Katherine Tyner, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 4146, Silver Spring, MD 20993-0002, 301- 796-0085; or Stephen Ripley, Center for Biologics Evaluation and Research, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993, 240-402-7911. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for industry entitled ``Drug Products, Including Biological Products, That Contain Nanomaterials.'' This guidance applies to human drug products, including those that are biological products, in which a nanomaterial is present in the finished dosage form. This draft guidance discusses both general principles and specific considerations for the development of drug products containing nanomaterials, including considerations for establishing the equivalence of such products with other drugs. Considerations for quality, nonclinical, and clinical studies are discussed as they relate to drug products containing nanomaterials throughout product development and production. This draft guidance does not limit or classify the types of nanomaterials that can be used in drug products. Rather, it is focused on the deliberate and purposeful manipulation and control of dimensions to produce specific physicochemical properties which may warrant further evaluation with regards to safety, effectiveness, performance, and quality. This guidance does not address, or presuppose, what ultimate regulatory outcome, if any, will result for a particular drug product that contains nanomaterials. Issues such as the safety, effectiveness, public health impact, or the regulatory status of drug products that contains nanomaterials are currently addressed on a case- by-case basis using FDA's existing review processes. Current CDER and CBER guidance documents and requirements for the evaluation and maintenance of quality, safety, and efficacy, apply to drug product containing nanomaterials that otherwise fall within their scopes. In addition, the Agency may continue to develop guidance addressing certain specific commonly-used types of nanomaterials, e.g., some liposomes, to better address the challenges in evaluating and characterizing the quality and performance of drug products that incorporate them. This draft guidance is one of several FDA guidance documents related to FDA-regulated products that may involve the use of nanotechnology. FDA has not established regulatory definitions of ``nanotechnology,'' ``nanomaterial,'' ``nanoscale,'' or other related terms. In Guidance for Industry,'' Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology,'' issued in 2014, FDA described certain considerations for determining whether FDA- regulated products involve the application of nanotechnology. FDA will apply these considerations broadly to all FDA-regulated products, including drug products within the scope of this draft guidance. The use of the term ``nanomaterial'' in this draft guidance, as in other FDA guidance documents, does not constitute the establishment of a regulatory definition. Rather, we use this term for ease of reference only. See section II of the draft guidance for additional information. FDA requests comment on the draft guidance. We also seek comment on the terminology, including the term ``nanomaterial'', as used in the draft guidance. 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 Drug Products, Including Biological Products, That Contain Nanomaterials. 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. The Paperwork Reduction Act of 1995 This draft guidance includes recommendations related to collections of information that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520). The collections of information that are related to the burden of submitting investigational new drug applications are covered under 21 CFR part 312 and have been approved under OMB control number 0910-0014. The collections of information related to the burden of submitting new drug applications, including supplemental applications, are covered under 21 CFR part 314 and have been approved under OMB control number 0910-0001. The collections of information related to the burden of submitting section 351(k) biosimilar applications have been approved under OMB control number 0910-0719. The collections of information related to the burden of complying with the current good manufacturing process recordkeeping requirements under 21 CFR part 211 have been approved under OMB control number 0910-0139. The collections of information related to the burden of complying with the environmental impact requirements under 21 CFR part 25 have been approved under OMB control number 0910-0322. The design and testing of prescription drug labeling required under 21 CFR 201.56 and 201.57 is approved under OMB control number [[Page 60021]] 0910-0572. Concerning the immediate container label and outer container or package, in the Federal Register of December 18, 2014 (79 FR 75506), we published a proposed rule on the electronic distribution of prescribing information for human prescription drugs, including biological products. In Section VII, Paperwork Reduction Act of 1995, we estimated the burden to design (including revisions), test, and produce the label for a drug's immediate container and outer container or package, as set forth in 21 CFR part 201 and other sections in subpart A and subpart B. III. Electronic Access Persons with access to the internet may obtain the draft guidance at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https;www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, or https://www.regulations.gov. Dated: December 12, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017-27133 Filed 12-15-17; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 82, No. 241 / Monday, December 18, 2017 / Notices 60019
(GDUFA I), beginning October 1, 2012, II. Paperwork Reduction Act of 1995 Electronic Submissions
FDA agreed to act on received ANDAs Submit electronic comments in the
This draft guidance refers to
within established time frames. As part following way:
previously approved collections of
of this undertaking, the Agency • Federal eRulemaking Portal:
information found in FDA regulations.
instituted the use of multiple forms of https://www.regulations.gov. Follow the
These collections of information are
communicating with an applicant instructions for submitting comments.
subject to review by the Office of
regarding the review of an application, Comments submitted electronically,
Management and Budget (OMB) under
including issuance of Complete including attachments, to https://
the Paperwork Reduction Act of 1995
Response Letters (CRLs) and IRs.1 www.regulations.gov will be posted to
Under GDUFA I, FDA issued a CRL (44 U.S.C. 3501–3520). The collection of
information has been approved under the docket unchanged. Because your
after completing a review of an ANDA.
OMB control number 0910–0797. comment will be made public, you are
The CRL described all the deficiencies
solely responsible for ensuring that your
identified in the ANDA that must be III. Electronic Access
satisfactorily addressed before the comment does not include any
ANDA can be approved. Issuance of a Persons with access to the internet confidential information that you or a
CRL also completed the ANDA’s review may obtain the draft guidance at either third party may not wish to be posted,
cycle, with the next review cycle https://www.fda.gov/Drugs/Guidance such as medical information, your or
beginning when the applicant amended ComplianceRegulatoryInformation/ anyone else’s Social Security number, or
the ANDA by submitting a complete Guidances/default.htm or https:// confidential business information, such
response to all deficiencies listed in the www.regulations.gov. as a manufacturing process. Please note
CRL. Dated: December 12, 2017. that if you include your name, contact
FDA used IRs to ask for information information, or other information that
Leslie Kux,
that would assist reviewers during the identifies you in the body of your
Associate Commissioner for Policy.
course of the review or to convey comments, that information will be
[FR Doc. 2017–27124 Filed 12–15–17; 8:45 am] posted on https://www.regulations.gov.
deficiencies identified in the
application in advance of a CRL. IRs did
BILLING CODE 4164–01–P • If you want to submit a comment
not stop the review clock, did not signal with confidential information that you
the completion of a review cycle, and do not wish to be made available to the
DEPARTMENT OF HEALTH AND public, submit the comment as a
were not always used consistently HUMAN SERVICES
across divisions or offices. written/paper submission and in the
In negotiations held as part of the Food and Drug Administration manner detailed (see ‘‘Written/Paper
Generic Drug User Fee Amendments of Submissions’’ and ‘‘Instructions’’).
2017 (GDUFA II), it was agreed that Written/Paper Submissions
[Docket No. FDA–2017–D–0759]
FDA will: (1) Issue an IR to request
further information or clarification that Submit written/paper submissions as
Drug Products, Including Biological follows:
is needed or would be helpful to allow Products, That Contain Nanomaterials;
completion of a discipline review and/ • Mail/Hand delivery/Courier (for
Draft Guidance for Industry; written/paper submissions): Dockets
or (2) issue a new type of letter for Availability
ANDAs, known as a DRL, to convey Management Staff (HFA–305), Food and
preliminary thoughts on possible AGENCY: Food and Drug Administration, Drug Administration, 5630 Fishers
deficiencies found by a discipline HHS. Lane, Rm. 1061, Rockville, MD 20852.
reviewer and/or review team for its or • For written/paper comments
ACTION: Notice of availability.
their portion of the application under submitted to the Dockets Management
review at the conclusion of a discipline SUMMARY: The Food and Drug Staff, FDA will post your comment, as
review.2 Administration (FDA or Agency) is well as any attachments, except for
This draft guidance is being issued announcing the availability of a draft information submitted, marked and
consistent with FDA’s good guidance guidance for industry entitled ‘‘Drug identified, as confidential, if submitted
practices regulation (21 CFR 10.115). Products, Including Biological Products, as detailed in ‘‘Instructions.’’
The draft guidance, when finalized, will that Contain Nanomaterials.’’ This draft Instructions: All submissions received
represent the current thinking of FDA guidance has been developed to provide must include the Docket No. FDA–
on ‘‘Information Requests and industry with the Agency’s current 2017–D–0759 for ‘‘Drug Products,
Discipline Review Letters Under thinking for the development of human Including Biological Products, that
GDUFA.’’ It does not establish any drug products, including those that are Contain Nanomaterials.’’ Received
rights for any person and is not binding biological products, that contain comments will be placed in the docket
on FDA or the public. You can use an nanomaterials. The draft guidance also and, except for those submitted as
alternative approach if it satisfies the includes recommendations for ‘‘Confidential Submissions,’’ publicly
requirements of the applicable statutes applicants and sponsors of viewable at https://www.regulations.gov
and regulations. investigational, premarket, and or at the Dockets Management Staff
postmarket submissions for these between 9 a.m. and 4 p.m., Monday
1 Food and Drug Administration Safety and
products. through Friday.
Innovation Act of 2012 (FDASIA), Public Law 112– Confidential Submissions—To submit
144 (2012). FDASIA includes GDUFA I, and by DATES: Submit either electronic or a comment with confidential
daltland on DSKBBV9HB2PROD with NOTICES
reference, the Generic Drug User Fee Act Program written comments on the draft guidance
Performance Goals and Procedures (GDUFA I information that you do not wish to be
Commitment Letter). by March 19, 2018 to ensure that the made publicly available, submit your
2 FDA Reauthorization Act of 2017 (FDARA), Agency considers your comment on this comments only as a written/paper
Public Law 115–52 (2017). FDARA includes draft guidance before it begins work on submission. You should submit two
GDUFA II, and by reference, the GDUFA the final version of the guidance.
Reauthorization Performance Goals and Program
copies total. One copy will include the
Enhancements Fiscal Years 2018–2022 (GDUFA II ADDRESSES: You may submit comments information you claim to be confidential
Commitment Letter). on any guidance at any time as follows: with a heading or cover note that states
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![Federal Register / Vol. 82, No. 241 / Monday, December 18, 2017 / Notices 60021
0910–0572. Concerning the immediate DATES: Submit either electronic or • Confidential Submissions—To
container label and outer container or written comments on the draft guidance submit a comment with confidential
package, in the Federal Register of by February 16, 2018 to ensure that the information that you do not wish to be
December 18, 2014 (79 FR 75506), we Agency considers your comment on this made publicly available, submit your
published a proposed rule on the draft guidance before it begins work on comments only as a written/paper
electronic distribution of prescribing the final version of the guidance. submission. You should submit two
information for human prescription ADDRESSES: You may submit comments copies total. One copy will include the
drugs, including biological products. In on any guidance at any time as follows: information you claim to be confidential
Section VII, Paperwork Reduction Act of with a heading or cover note that states
1995, we estimated the burden to design Electronic Submissions ‘‘THIS DOCUMENT CONTAINS
(including revisions), test, and produce Submit electronic comments in the CONFIDENTIAL INFORMATION.’’ The
the label for a drug’s immediate following way: Agency will review this copy, including
container and outer container or • Federal eRulemaking Portal: the claimed confidential information, in
package, as set forth in 21 CFR part 201 https://www.regulations.gov. Follow the its consideration of comments. The
and other sections in subpart A and instructions for submitting comments. second copy, which will have the
subpart B. Comments submitted electronically, claimed confidential information
including attachments, to https:// redacted/blacked out, will be available
III. Electronic Access
www.regulations.gov will be posted to for public viewing and posted on
Persons with access to the internet the docket unchanged. Because your https://www.regulations.gov. Submit
may obtain the draft guidance at either comment will be made public, you are both copies to the Dockets Management
https://www.fda.gov/Drugs/Guidance solely responsible for ensuring that your Staff. If you do not wish your name and
ComplianceRegulatoryInformation/ comment does not include any contact information to be made publicly
Guidances/default.htm, confidential information that you or a available, you can provide this
https;www.fda.gov/ third party may not wish to be posted, information on the cover sheet and not
BiologicsBloodVaccines/Guidance such as medical information, your or in the body of your comments and you
ComplianceRegulatoryInformation/ anyone else’s Social Security number, or must identify this information as
default.htm, or https:// confidential business information, such ‘‘confidential.’’ Any information marked
www.regulations.gov. as a manufacturing process. Please note as ‘‘confidential’’ will not be disclosed
Dated: December 12, 2017. that if you include your name, contact except in accordance with 21 CFR 10.20
Leslie Kux, information, or other information that and other applicable disclosure law. For
identifies you in the body of your more information about FDA’s posting
Associate Commissioner for Policy.
comments, that information will be of comments to public dockets, see 80
[FR Doc. 2017–27133 Filed 12–15–17; 8:45 am]
posted on https://www.regulations.gov. FR 56469, September 18, 2015, or access
BILLING CODE 4164–01–P
• If you want to submit a comment the information at: https://www.gpo.gov/
with confidential information that you fdsys/pkg/FR-2015-09-18/pdf/2015-
do not wish to be made available to the 23389.pdf.
DEPARTMENT OF HEALTH AND
public, submit the comment as a Docket: For access to the docket to
HUMAN SERVICES
written/paper submission and in the read background documents or the
Food and Drug Administration manner detailed (see ‘‘Written/Paper electronic and written/paper comments
Submissions’’ and ‘‘Instructions’’). received, go to https://
www.regulations.gov and insert the
[Docket No. FDA–2017–D–6617] Written/Paper Submissions docket number, found in brackets in the
Developing Targeted Therapies in Low- Submit written/paper submissions as heading of this document, into the
Frequency Molecular Subsets of a follows: ‘‘Search’’ box and follow the prompts
Disease; Draft Guidance for Industry; • Mail/Hand delivery/Courier (for and/or go to the Dockets Management
Availability written/paper submissions): Dockets Staff, 5630 Fishers Lane, Rm. 1061,
Management Staff (HFA–305), Food and Rockville, MD 20852.
AGENCY: Food and Drug Administration, Drug Administration, 5630 Fishers You may submit comments on any
HHS. Lane, Rm. 1061, Rockville, MD 20852. guidance at any time (see 21 CFR
ACTION: Notice of availability. • For written/paper comments 10.115(g)(5)).
submitted to the Dockets Management Submit written requests for single
SUMMARY: The Food and Drug Staff, FDA will post your comment, as copies of the draft guidance to the
Administration (FDA or Agency) is well as any attachments, except for Division of Drug Information, Center for
announcing the availability of a draft information submitted, marked and Drug Evaluation and Research, Food
guidance for industry entitled identified, as confidential, if submitted and Drug Administration, 10001 New
‘‘Developing Targeted Therapies in as detailed in ‘‘Instructions.’’ Hampshire Ave., Hillandale Building,
Low-Frequency Molecular Subsets of a Instructions: All submissions received 4th Floor, Silver Spring, MD 20993–
Disease.’’ The purpose of this guidance must include the Docket No. FDA– 0002; or the Office of Communication,
is to describe the FDA’s current 2017–D–6617 for ‘‘Developing Targeted Outreach, and Development, Center for
recommendations on how to group Therapies in Low-Frequency Molecular Biologics Evaluation and Research,
patients with different molecular Subsets of a Disease.’’ Received Food and Drug Administration, 10903
daltland on DSKBBV9HB2PROD with NOTICES
alterations for eligibility in clinical comments will be placed in the docket New Hampshire Ave., Bldg. 71, Rm.
trials; and general approaches to and, except for those submitted as 3128, Silver Spring, MD 20993–0002.
evaluating the benefits and risks of ‘‘Confidential Submissions,’’ publicly Send one self-addressed adhesive label
targeted therapeutics within a clinically viewable at https://www.regulations.gov to assist that office in processing your
defined disease where some molecular or at the Dockets Management Staff requests. See the SUPPLEMENTARY
alterations may occur at low between 9 a.m. and 4 p.m., Monday INFORMATION section for electronic
frequencies. through Friday. access to the draft guidance document.
VerDate Sep<11>2014 17:53 Dec 15, 2017 Jkt 244001 PO 00000 Frm 00022 Fmt 4703 Sfmt 4703 E:\FR\FM\18DEN1.SGM 18DEN1](https://thefederalregister.org/doc/82_FR_60260/page/3.svg)
Document Created: 2017-12-15 23:54:50
Document Modified: 2017-12-15 23:54:50
| 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 | Submit either electronic or written comments on the draft guidance by March 19, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. | |
| Contact | Katherine Tyner, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 4146, Silver Spring, MD 20993-0002, 301- 796-0085; or Stephen Ripley, Center for Biologics Evaluation and Research, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993, 240-402-7911. | |
| FR Citation | 82 FR 60019 |
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