82 FR 60204 - Standards Development and the Use of Standards in Regulatory Submissions Reviewed in the Center for Biologics Evaluation and Research; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 242 (December 19, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 242 (December 19, 2017)
| Page Range | 60204-60206 | |
| FR Document | 2017-27275 |
[Federal Register Volume 82, Number 242 (Tuesday, December 19, 2017)] [Notices] [Pages 60204-60206] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-27275] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-D-6535] Standards Development and the Use of Standards in Regulatory Submissions Reviewed in the Center for Biologics Evaluation and Research; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS.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 document entitled ``Standards Development and the Use of Standards in Regulatory Submissions Reviewed in the Center for Biologics Evaluation and Research; Draft Guidance for Industry and Food and Drug Administration Staff.'' The draft guidance document recognizes the value of standards and encourages the use of appropriate standards to facilitate the evaluation of products regulated by the Center for Biologics Evaluation and Research (CBER). The guidance describes CBER's recommendations on the use of standards in product development and the use of such standards in CBER's managed review process. The draft guidance does not endorse the activities of specific Standards Development Organizations or recommend specific standards for use in regulatory submissions. DATES: Submit either electronic or written comments on the draft guidance by March 19, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.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: [[Page 60205]]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-6535 for ``Standards Development and the Use of Standards in Regulatory Submissions Reviewed in the Center for Biologics Evaluation and Research; Draft Guidance for Industry and Food and Drug Administration Staff.'' 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 the draft guidance to 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 the office in processing your requests. The draft guidance may also be obtained by mail by calling CBER at 1-800-835-4709 or 240-402-8010. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. FOR FURTHER INFORMATION CONTACT: Angela Moy, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240- 402-7911. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft document entitled ``Standards Development and the Use of Standards in Regulatory Submissions Reviewed in the Center for Biologics Evaluation and Research; Draft Guidance for Industry and Food and Drug Administration Staff.'' The Federal Government's policies on the use of standards developed by voluntary consensus standard bodies are described in the Office of Management and Budget Circular A-119, ``Federal Participation in the Development and Use of Voluntary Consensus Standards and in Conformity Assessment Activities.'' The policies outlined in Circular A-119 were codified in the National Technology Transfer and Advancement Act of 1995 (NTTAA). The NTTAA authorizes the National Institute of Standards and Technology to coordinate standards activities for Federal Agencies. CBER recognizes the value of standards and encourages the use of appropriate standards in the development of CBER-regulated medical products. Sponsors' use of standards can facilitate product development and a more efficient evaluation of regulatory submissions. The draft guidance describes CBER's recommendations on the use of standards in product development and the use of such standards in CBER's managed review process. It describes how standards are developed, the benefits of using standards, and CBER's policy on accepting standards used in regulatory submissions. CBER's use of, and CBER's acceptance of sponsors' use of, voluntary consensus standards do not constitute a delegation of CBER's regulatory responsibilities. Whether or not standards are used, CBER retains the ability to set, and the responsibility for setting, appropriate regulatory criteria for CBER- regulated products. 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 standards development and the use of standards in regulatory submissions reviewed in CBER. 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. Electronic Access Persons with access to the internet may obtain the draft guidance at either https://www.fda.gov/BiologicsBloodVaccines/ GuidanceComplianceRegulatoryInformation/Guidances/ [[Page 60206]] default.htm or https://www.regulations.gov. Dated: December 14, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017-27275 Filed 12-18-17; 8:45 am] BILLING CODE 4164-01-P
![60204 Federal Register / Vol. 82, No. 242 / Tuesday, December 19, 2017 / Notices
revised burden estimates for the current regulations so that we can In the Federal Register of April 25,
proposed changes and solicited public continue to collect information while 2017 (82 FR 19054), FDA published a
comment. In response to requests, the the proposal is pending. 60-day notice requesting public
comment period was extended to Description of Respondents: The comment on the proposed collection of
January 21, 2017 (81 FR 75351, October likely respondents collecting this information. We received no comments.
31, 2016). In the interim, FDA is seeking information are contract laboratories,
sponsors of FDA-regulated products, FDA estimates the burden of this
an extension of OMB approval for the collection of information as follows:
universities, or government agencies.
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
21 CFR section/activity responses per burden per Total hours
respondents responses
respondent response
58.35(b)(7); Quality assurance unit ..................................... 300 60.25 18,075 1 18,075
58.185; Reporting of nonclinical laboratory study results ... 300 60.25 18,075 27.65 499,774
Total .............................................................................. ........................ ........................ ........................ ........................ 517,849
1 There are no capital costs or operating maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of Average burden
Number of Total annual
21 CFR section/activity records per per recordkeeping Total hours
recordkeepers records
recordkeeper (in hours)
58.29(b); Personnel ................................................. 300 20 6,000 .21 (13 minutes) ........ 1,260
58.35(b)(1)–(6), and (c); Quality assurance unit ..... 300 270.76 81,228 3.36 ........................... 272,926
58.63(b) and (c); Maintenance and calibration of 300 60 18,000 .09 (5 minutes) .......... 1,620
equipment.
58.81(a)–(c); SOPs .................................................. 300 301.8 90,540 .14 (8 minutes) .......... 12,676
58.90(c) and (g); Animal care .................................. 300 62.7 18,810 .13 (8 minutes) .......... 2,445
58.105(a) and (b); Test and control article charac- 300 5 1,500 11.8 ........................... 17,700
terization.
58.107(d); Test and control article handling ............ 300 1 300 4.25 ........................... 1,275
58.113(a); Mixtures of articles with carriers ............ 300 15.33 4,599 6.8 ............................. 31,273
58.120; Protocol ....................................................... 300 15.38 4,614 32.7 ........................... 150,878
58.195; Retention of records ................................... 300 251.5 75,450 3.9 ............................. 294,255
Total .................................................................. ........................ ........................ ........................ .................................... 786,308
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
The annual burden for the DEPARTMENT OF HEALTH AND recognizes the value of standards and
information collection requirements in HUMAN SERVICES encourages the use of appropriate
these regulations is estimated at standards to facilitate the evaluation of
1,304,157 burden hours (517,849 + Food and Drug Administration products regulated by the Center for
786,308 = 1,304,157). The hours per Biologics Evaluation and Research
[Docket No. FDA–2017–D–6535] (CBER). The guidance describes CBER’s
response estimates are based on our
experience with similar programs and recommendations on the use of
Standards Development and the Use of standards in product development and
information received from industry. Standards in Regulatory Submissions the use of such standards in CBER’s
Dated: December 13, 2017. Reviewed in the Center for Biologics managed review process. The draft
Leslie Kux, Evaluation and Research; Draft guidance does not endorse the activities
Guidance for Industry and Food and of specific Standards Development
Associate Commissioner for Policy.
Drug Administration Staff; Availability Organizations or recommend specific
[FR Doc. 2017–27255 Filed 12–18–17; 8:45 am]
BILLING CODE 4164–01–P AGENCY: Food and Drug Administration, standards for use in regulatory
HHS. submissions.
ACTION: Notice of availability. DATES: Submit either electronic or
written comments on the draft guidance
SUMMARY: The Food and Drug by March 19, 2018 to ensure that the
Administration (FDA or Agency) is Agency considers your comment on this
announcing the availability of a draft
sradovich on DSK3GMQ082PROD with NOTICES
draft guidance before it begins work on
document entitled ‘‘Standards the final version of the guidance.
Development and the Use of Standards ADDRESSES: You may submit comments
in Regulatory Submissions Reviewed in on any guidance at any time as follows:
the Center for Biologics Evaluation and
Research; Draft Guidance for Industry Electronic Submissions
and Food and Drug Administration Submit electronic comments in the
Staff.’’ The draft guidance document following way:
VerDate Sep<11>2014 17:47 Dec 18, 2017 Jkt 244001 PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 E:\FR\FM\19DEN1.SGM 19DEN1](https://thefederalregister.org/doc/82_FR_60446/page/1.svg)
![60206 Federal Register / Vol. 82, No. 242 / Tuesday, December 19, 2017 / Notices
default.htm or https:// public, submit the comment as a fdsys/pkg/FR-2015-09-18/pdf/2015-
www.regulations.gov. written/paper submission and in the 23389.pdf.
Dated: December 14, 2017. manner detailed (see ‘‘Written/Paper Docket: For access to the docket to
Leslie Kux,
Submissions’’ and ‘‘Instructions’’). read the electronic and written/paper
comments received, go to https://
Associate Commissioner for Policy. Written/Paper Submissions
www.regulations.gov and insert the
[FR Doc. 2017–27275 Filed 12–18–17; 8:45 am] Submit written/paper submissions as docket number, found in brackets in the
BILLING CODE 4164–01–P follows: heading of this document, into the
• Mail/Hand delivery/Courier (for ‘‘Search’’ box and follow the prompts
written/paper submissions): Dockets and/or go to the Dockets Management
DEPARTMENT OF HEALTH AND Management Staff (HFA–305), Food and Staff, 5630 Fishers Lane, Rm. 1061,
HUMAN SERVICES Drug Administration, 5630 Fishers Rockville, MD 20852.
Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Paul
Food and Drug Administration • For written/paper comments
submitted to the Dockets Management Hart, Center for Tobacco Products, Food
[Docket No. FDA–2017–N–4678] and Drug Administration, 10903 New
Staff, FDA will post your comment, as
Modified Risk Tobacco Product well as any attachments, except for Hampshire Ave., Bldg. 71, Rm. G335,
Applications: Applications for Six information submitted, marked and Silver Spring, MD 20993–0002, 1–877–
Camel Snus Smokeless Tobacco identified, as confidential, if submitted 287–1373, email: AskCTP@fda.hhs.gov.
Products Submitted by R.J. Reynolds as detailed in ‘‘Instructions.’’ SUPPLEMENTARY INFORMATION:
Tobacco Company; Availability Instructions: All submissions received I. Background
must include the Docket No. FDA–
AGENCY: Food and Drug Administration, 2017–N–4678 for ‘‘Modified Risk Section 911 of the Federal Food, Drug,
HHS. Tobacco Product Applications: and Cosmetic Act (FD&C Act) (21 U.S.C.
ACTION: Notice. Applications for Six Camel Snus 387k) addresses the marketing and
Smokeless Tobacco Products Submitted distribution of modified risk tobacco
SUMMARY: The Food and Drug by R.J. Reynolds Tobacco Company.’’ products (MRTPs). MRTPs are tobacco
Administration (FDA or Agency) is Received comments will be placed in products that are sold or distributed for
announcing the availability for public the docket and, except for those use to reduce harm or the risk of
comment of modified risk tobacco submitted as ‘‘Confidential tobacco-related disease associated with
product applications (MRTPAs) for six Submissions,’’ publicly viewable at commercially marketed tobacco
Camel Snus smokeless tobacco products https://www.regulations.gov or at the products. Section 911(a) of the FD&C
submitted by R.J. Reynolds Tobacco Co. Dockets Management Staff between 9 Act prohibits the introduction or
DATES: Electronic or written comments a.m. and 4 p.m., Monday through delivery for introduction into interstate
on the applications may be submitted Friday. commerce of any MRTP unless an order
until June 18, 2018; however, FDA may • Confidential Submissions—To issued by FDA under section 911(g) of
modify the comment period by submit a comment with confidential the FD&C Act is effective with respect
providing notice as described in section information that you do not wish to be to such product.
I. made publicly available, submit your Section 911(d) of the FD&C Act
ADDRESSES: You may submit comments comments only as a written/paper describes the information that must be
as follows: submission. You should submit two included in an MRTPA, which must be
copies total. One copy will include the filed and evaluated by FDA before an
Electronic Submissions information you claim to be confidential applicant can receive an order from
Submit electronic comments in the with a heading or cover note that states FDA. FDA is required by section 911(e)
following way: ‘‘THIS DOCUMENT CONTAINS of the FD&C Act to make an MRTPA
• Federal eRulemaking Portal: CONFIDENTIAL INFORMATION.’’ The available to the public (except for
https://www.regulations.gov. Follow the Agency will review this copy, including matters in the application that are trade
instructions for submitting comments. the claimed confidential information, in secrets or otherwise confidential
Comments submitted electronically, its consideration of comments. The commercial information) and to request
including attachments, to https:// second copy, which will have the comments by interested persons on the
www.regulations.gov will be posted to claimed confidential information information contained in the
the docket unchanged. Because your redacted/blacked out, will be available application and on the label, labeling,
comment will be made public, you are for public viewing and posted on and advertising accompanying the
solely responsible for ensuring that your https://www.regulations.gov. Submit application. The determination of
comment does not include any both copies to the Dockets Management whether an order is appropriate under
confidential information that you or a Staff. If you do not wish your name and section 911(g) of the FD&C Act is based
third party may not wish to be posted, contact information to be made publicly on the scientific information submitted
such as medical information, your or available, you can provide this by the applicant as well as the scientific
anyone else’s Social Security number, or information on the cover sheet and not evidence and other information that is
confidential business information, such in the body of your comments and you made available to the Agency, including
as a manufacturing process. Please note must identify this information as through public comments.
that if you include your name, contact ‘‘confidential.’’ Any information marked Section 911(g) of the FD&C Act
sradovich on DSK3GMQ082PROD with NOTICES
information, or other information that as ‘‘confidential’’ will not be disclosed describes the demonstrations applicants
identifies you in the body of your except in accordance with 21 CFR 10.20 must make to obtain an order from FDA
comments, that information will be and other applicable disclosure law. For under either section 911(g)(1) or (2). The
posted on https://www.regulations.gov. more information about FDA’s posting applicant, R.J. Reynolds Tobacco Co., is
• If you want to submit a comment of comments to public dockets, see 80 seeking orders under section 911(g)(1)
with confidential information that you FR 56469, September 18, 2015, or access for each of the 6 products that are the
do not wish to be made available to the the information at: https://www.gpo.gov/ subject of the submitted MRTPAs. A
VerDate Sep<11>2014 17:47 Dec 18, 2017 Jkt 244001 PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 E:\FR\FM\19DEN1.SGM 19DEN1](https://thefederalregister.org/doc/82_FR_60446/page/3.svg)
Document Created: 2017-12-19 01:31:12
Document Modified: 2017-12-19 01:31:12
| 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 | Angela Moy, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240- 402-7911. | |
| FR Citation | 82 FR 60204 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR