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and the Use of Standards in Regulatory Submissions Reviewed in the Center for Biologics Evaluation and Research; Draft Guidance for Industry and Food and Drug Administration Staff; Availability, 60204-60206 [2017-27275]

Download as PDF 60204 Federal Register / Vol. 82, No. 242 / Tuesday, December 19, 2017 / Notices revised burden estimates for the proposed changes and solicited public comment. In response to requests, the comment period was extended to January 21, 2017 (81 FR 75351, October 31, 2016). In the interim, FDA is seeking an extension of OMB approval for the In the Federal Register of April 25, 2017 (82 FR 19054), FDA published a 60-day notice requesting public comment on the proposed collection of information. We received no comments. FDA estimates the burden of this collection of information as follows: current regulations so that we can continue to collect information while the proposal is pending. Description of Respondents: The likely respondents collecting this information are contract laboratories, sponsors of FDA-regulated products, universities, or government agencies. TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of respondents 21 CFR section/activity Number of responses per respondent Total annual responses Average burden per response Total hours 58.35(b)(7); Quality assurance unit ..................................... 58.185; Reporting of nonclinical laboratory study results ... 300 300 60.25 60.25 18,075 18,075 1 27.65 18,075 499,774 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 recordkeepers 21 CFR section/activity Number of records per recordkeeper Total annual records Average burden per recordkeeping (in hours) Total hours 58.29(b); Personnel ................................................. 58.35(b)(1)–(6), and (c); Quality assurance unit ..... 58.63(b) and (c); Maintenance and calibration of equipment. 58.81(a)–(c); SOPs .................................................. 58.90(c) and (g); Animal care .................................. 58.105(a) and (b); Test and control article characterization. 58.107(d); Test and control article handling ............ 58.113(a); Mixtures of articles with carriers ............ 58.120; Protocol ....................................................... 58.195; Retention of records ................................... 300 300 300 20 270.76 60 6,000 81,228 18,000 .21 (13 minutes) ........ 3.36 ........................... .09 (5 minutes) .......... 1,260 272,926 1,620 300 300 300 301.8 62.7 5 90,540 18,810 1,500 .14 (8 minutes) .......... .13 (8 minutes) .......... 11.8 ........................... 12,676 2,445 17,700 300 300 300 300 1 15.33 15.38 251.5 300 4,599 4,614 75,450 4.25 ........................... 6.8 ............................. 32.7 ........................... 3.9 ............................. 1,275 31,273 150,878 294,255 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 information collection requirements in these regulations is estimated at 1,304,157 burden hours (517,849 + 786,308 = 1,304,157). The hours per response estimates are based on our experience with similar programs and information received from industry. Dated: December 13, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017–27255 Filed 12–18–17; 8:45 am] 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: BILLING CODE 4164–01–P Food and Drug Administration, HHS. ACTION: Notice of availability. 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 sradovich on DSK3GMQ082PROD with NOTICES SUMMARY: VerDate Sep<11>2014 17:47 Dec 18, 2017 Jkt 244001 PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 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: E:\FR\FM\19DEN1.SGM 19DEN1 Federal Register / Vol. 82, No. 242 / Tuesday, December 19, 2017 / Notices sradovich on DSK3GMQ082PROD with NOTICES • 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 VerDate Sep<11>2014 17:47 Dec 18, 2017 Jkt 244001 ‘‘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.gpo.gov/ fdsys/pkg/FR-2015-09-18/pdf/201523389.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 PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 60205 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/Biologics BloodVaccines/GuidanceCompliance RegulatoryInformation/Guidances/ E:\FR\FM\19DEN1.SGM 19DEN1 60206 Federal Register / Vol. 82, No. 242 / Tuesday, December 19, 2017 / Notices public, submit the comment as a written/paper submission and in the manner detailed (see ‘‘Written/Paper Submissions’’ and ‘‘Instructions’’). 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2017–N–4678] Modified Risk Tobacco Product Applications: Applications for Six Camel Snus Smokeless Tobacco Products Submitted by R.J. Reynolds Tobacco Company; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or Agency) is announcing the availability for public comment of modified risk tobacco product applications (MRTPAs) for six Camel Snus smokeless tobacco products submitted by R.J. Reynolds Tobacco Co. DATES: Electronic or written comments on the applications may be submitted until June 18, 2018; however, FDA may modify the comment period by providing notice as described in section I. ADDRESSES: You may submit comments as follows: SUMMARY: sradovich on DSK3GMQ082PROD with NOTICES 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 VerDate Sep<11>2014 17:47 Dec 18, 2017 Jkt 244001 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–N–4678 for ‘‘Modified Risk Tobacco Product Applications: Applications for Six Camel Snus Smokeless Tobacco Products Submitted by R.J. Reynolds Tobacco Company.’’ 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.gpo.gov/ PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf. Docket: For access to the docket to read 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. FOR FURTHER INFORMATION CONTACT: Paul Hart, Center for Tobacco Products, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. G335, Silver Spring, MD 20993–0002, 1–877– 287–1373, email: AskCTP@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background Section 911 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 387k) addresses the marketing and distribution of modified risk tobacco products (MRTPs). MRTPs are tobacco products that are sold or distributed for use to reduce harm or the risk of tobacco-related disease associated with commercially marketed tobacco products. Section 911(a) of the FD&C Act prohibits the introduction or delivery for introduction into interstate commerce of any MRTP unless an order issued by FDA under section 911(g) of the FD&C Act is effective with respect to such product. Section 911(d) of the FD&C Act describes the information that must be included in an MRTPA, which must be filed and evaluated by FDA before an applicant can receive an order from FDA. FDA is required by section 911(e) of the FD&C Act to make an MRTPA available to the public (except for matters in the application that are trade secrets or otherwise confidential commercial information) and to request comments by interested persons on the information contained in the application and on the label, labeling, and advertising accompanying the application. The determination of whether an order is appropriate under section 911(g) of the FD&C Act is based on the scientific information submitted by the applicant as well as the scientific evidence and other information that is made available to the Agency, including through public comments. Section 911(g) of the FD&C Act describes the demonstrations applicants must make to obtain an order from FDA under either section 911(g)(1) or (2). The applicant, R.J. Reynolds Tobacco Co., is seeking orders under section 911(g)(1) for each of the 6 products that are the subject of the submitted MRTPAs. A E:\FR\FM\19DEN1.SGM 19DEN1

Agencies

[Federal Register Volume 82, Number 242 (Tuesday, December 19, 2017)]
[Notices]
[Pages 60204-60206]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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.gpo.gov/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