Providing Regulatory Submissions in Electronic Format-Submission of Manufacturing Establishment Information; Draft Guidance for Industry; Availability, 96013-96015 [2016-31626]

Download as PDF Federal Register / Vol. 81, No. 250 / Thursday, December 29, 2016 / Notices comparable approved radiopharmaceutical that produces for an identified individual patient a clinical difference, the determination is documented on the prescription or order in writing by either (1) the prescribing practitioner, or (2) the compounder, reflecting a conversation with the prescribing practitioner. The compounder maintains records of the prescription or order documenting this determination. We estimate that annually a total of approximately 10 compounders (‘‘No. of Respondents’’ in table 1, line 1) will consult a prescriber to determine whether he or she has made a determination that the compounded radiopharmaceutical has a change that produces a clinical difference for an identified individual patient as compared to the comparable approved radiopharmaceutical. We estimate that compounders will document this determination on approximately 250 prescriptions or orders for compounded radiopharmaceuticals ‘‘Total Annual Disclosures’’ in table 1, line 1). We estimate that the consultation between the compounder and the prescriber and noting this determination on each prescription or order that does not already document this determination will take approximately 3 minutes per prescription or order. 96013 A compounder also maintains records of prescriptions or orders noting the determination that a prescriber has determined that the compounded radiopharmaceutical has a change that produces a clinical difference for an identified individual patient. We estimate that the compounder will take approximately 2.1 hours to maintain the records of 250 prescriptions or orders documenting the prescriber’s determination of clinical difference (‘‘Total Hours’’ in table 2). We estimate that maintaining such records will take approximately 30 seconds per prescription or order. FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1 Type of reporting Number of respondents Number of disclosures per respondent Total annual disclosures Average burden per disclosure Total hours Consultation between the compounder and prescriber or health care facility, and the notation on the prescription or order documenting the prescriber’s determination of clinical difference. 10 25 250 3 minutes .... 12.5 1 There are no capital costs or operating and maintenance costs associated with this collection of information. TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 Type of reporting Number of recordkeepers Number of records per recordkeeper Total annual records Average burden per recordkeeping Total hours Maintenance of records of prescriptions or orders documenting the prescriber’s determination of clinical difference. 10 25 250 30 seconds .. 2.1 1 There are no capital costs or operating and maintenance costs associated with this collection of information. III. Electronic Access Persons with access to the Internet may obtain the draft guidance at either http://www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm or https:// www.regulations.gov. Dated: December 22, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–31513 Filed 12–28–16; 8:45 am] asabaliauskas on DSK3SPTVN1PROD with NOTICES BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2014–D–1953] Providing Regulatory Submissions in Electronic Format—Submission of Manufacturing Establishment Information; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ‘‘Providing Regulatory Submissions in Electronic Format—Submission of Manufacturing Establishment Information.’’ This guidance discusses the requirements for a valid electronic SUMMARY: VerDate Sep<11>2014 18:41 Dec 28, 2016 Jkt 241001 PO 00000 Frm 00058 Fmt 4703 Sfmt 4703 submission of manufacturing establishment information (MEI) under the Federal Food, Drug, and Cosmetic Act (the FD&C Act). This action will streamline the review of all manufacturing establishments involved in the preparation of a drug or biological product by consolidating information in one location and eliminating the inclusion of erroneous and/or outdated information from other Agency files. Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by February 27, 2017. DATES: ADDRESSES: You may submit comments as follows: E:\FR\FM\29DEN1.SGM 29DEN1 96014 Federal Register / Vol. 81, No. 250 / Thursday, December 29, 2016 / 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 public, submit the comment as a written/paper submission and in the manner detailed (see ‘‘Written/Paper Submissions’’ and ‘‘Instructions’’). asabaliauskas on DSK3SPTVN1PROD with NOTICES Written/Paper Submissions Submit written/paper submissions as follows: • Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Division of Dockets Management, 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– 2014–D–1953 for ‘‘Providing Regulatory Submissions in Electronic Format— Submission of Manufacturing Establishment Information.’’ 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 Division of Dockets Management 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 VerDate Sep<11>2014 18:41 Dec 28, 2016 Jkt 241001 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 Division of Dockets Management. 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: http://www.fda.gov/ regulatoryinformation/dockets/ default.htm. 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 Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. 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; or 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. Send one selfaddressed 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: Regarding drug products: Karen Takahashi, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 4244, Silver Spring, MD 20993–0002, 301–796–3191. PO 00000 Frm 00059 Fmt 4703 Sfmt 4703 Regarding biological products: Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 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 ‘‘Providing Regulatory Submissions in Electronic Format—Submission of Manufacturing Establishment Information.’’ This draft guidance discusses the requirements and implementation of section 745A(a) of the FD&C Act (21 U.S.C. 379k–1) regarding valid electronic submissions of MEI. Twentyfour months after this draft has been finalized, MEI contained in new drug applications (NDAs), abbreviated new drug applications (ANDAs), biologics license applications (BLAs), and amendments, supplements, or resubmissions of these application types must be submitted electronically in the format specified in this guidance. This draft guidance also applies to drug master files that are submitted for incorporation by reference into an NDA, ANDA, or BLA. Under current regulations at 21 CFR 314.50(d) and 21 CFR 601.2(a), applicants and holders of approved applications are required to submit contact information for each manufacturing establishment involved in the manufacture of the drug or biological product, as well as other information relating to the manufacture of the product. This information is part of the existing application form (FDA Form 356h, ‘‘Application to Market a New Drug, Biologic, or an Antibiotic Drug for Human Use’’). We have found that the MEI is sometimes incomplete, and scattered throughout electronic submissions. This can lead to delays in application processing. The Agency is requiring that applicants submit a single, consolidated list of information about each manufacturing establishment mentioned in any application. This information must include the name and address of each manufacturing establishment involved in the manufacture of the drug or biological product, specific information regarding the physical location of the establishment, facility identifiers assigned to the establishment by FDA, contact information for the person responsible for scheduling inspections at the establishment, and E:\FR\FM\29DEN1.SGM 29DEN1 Federal Register / Vol. 81, No. 250 / Thursday, December 29, 2016 / Notices the specific manufacturing operations conducted at the establishment. We believe the required electronic MEI can be consolidated to appear in a single location to facilitate the complete, timely, and accurate review of all manufacturing establishments involved in the preparation of a drug or biological product. This will help to eliminate the inclusion and/or maintenance of potentially outdated and erroneous information that could be retrieved from other Agency files and will enable proper identification and timely evaluation of manufacturing establishments for conformance with requirements, including current good manufacturing practices. II. Paperwork Reduction Act of 1995 The guidance refers to previously approved collections of information that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501–3520). The draft guidance discusses the electronic submission of MEI contained in an NDA, ANDA, or BLA to the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research by specifying the format for the electronic submission of such submissions. The information collection discussed in the guidance is contained in our NDA and ANDA regulations (part 314) and approved under OMB control number 0910–0001, and our BLA regulations (part 601) and approved under OMB control number 0910–0338. Currently, MEI is submitted as part of the existing application form, Form FDA 356h, and is approved by OMB under control number 0910–0338. III. Electronic Access asabaliauskas on DSK3SPTVN1PROD with NOTICES Persons with access to the Internet may obtain the document at http:// www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm, http:// www.fda.gov/BiologicsBloodVaccines/ GuidanceComplianceRegulatory Information/default.htm, or https:// www.regulations.gov. Dated: December 23, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–31626 Filed 12–28–16; 8:45 am] BILLING CODE 4164–01–P VerDate Sep<11>2014 18:41 Dec 28, 2016 Jkt 241001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–N–0879] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Procedures for the Safe and Sanitary Processing and Importing of Fish and Fishery Products AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of information by January 30, 2017. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202–395–7285, or emailed to oira_ submission@omb.eop.gov. All comments should be identified with the OMB control number 0910–0354. Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, PRAStaff@fda.hhs.gov. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. SUMMARY: Procedures for the Safe and Sanitary Processing and Importing of Fish and Fishery Products—21 CFR part 123 OMB Control Number 0910–0354— Extension FDA regulations in part 123 (21 CFR part 123) mandate the application of hazard analysis and critical control point (HACCP) principles to the processing of seafood. HACCP is a preventive system of hazard control designed to help ensure the safety of foods. The regulations were issued under FDA’s statutory authority to regulate food safety, including section 402(a)(1) and (4) of the Federal Food, PO 00000 Frm 00060 Fmt 4703 Sfmt 4703 96015 Drug, and Cosmetic Act (21 U.S.C. 342(a)(1) and (4)). Certain provisions in part 123 require that processors and importers of seafood collect and record information. The HACCP records compiled and maintained by a seafood processor primarily consist of the periodic observations recorded at selected monitoring points during processing and packaging operations, as called for in a processor’s HACCP plan (e.g., the values for processing times, temperatures, acidity, etc., as observed at critical control points). The primary purpose of HACCP records is to permit a processor to verify that products have been produced within carefully established processing parameters (critical limits) that ensure that hazards have been avoided. HACCP records are normally reviewed by appropriately trained employees at the end of a production lot or at the end of a day or week of production to verify that control limits have been maintained, or that appropriate corrective actions were taken if the critical limits were not maintained. Such verification activities are essential to ensure that the HACCP system is working as planned. A review of these records during the conduct of periodic plant inspections also permits FDA to determine whether the products have been consistently processed in conformance with appropriate HACCP food safety controls. Section 123.12 requires that importers of seafood products take affirmative steps and maintain records that verify that the fish and fishery products they offer for import into the United States were processed in accordance with the HACCP and sanitation provisions set forth in part 123. These records are also to be made available for review by FDA as provided in § 123.12(c). The time and costs of these recordkeeping activities will vary considerably among processors and importers of fish and fishery products, depending on the type and number of products involved, and on the nature of the equipment or instruments required to monitor critical control points. The burden estimate in table 1 includes only those collections of information under the seafood HACCP regulations that are not already required under other statutes and regulations. The estimate also does not include collections of information that are a usual and customary part of businesses’ normal activities. For example, the tagging and labeling of molluscan shellfish (21 CFR 1240.60) is a customary and usual practice among seafood processors. Consequently, the estimates in table 1 E:\FR\FM\29DEN1.SGM 29DEN1

Agencies

[Federal Register Volume 81, Number 250 (Thursday, December 29, 2016)]
[Notices]
[Pages 96013-96015]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-31626]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-1953]


Providing Regulatory Submissions in Electronic Format--Submission 
of Manufacturing Establishment Information; 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 ``Providing 
Regulatory Submissions in Electronic Format--Submission of 
Manufacturing Establishment Information.'' This guidance discusses the 
requirements for a valid electronic submission of manufacturing 
establishment information (MEI) under the Federal Food, Drug, and 
Cosmetic Act (the FD&C Act). This action will streamline the review of 
all manufacturing establishments involved in the preparation of a drug 
or biological product by consolidating information in one location and 
eliminating the inclusion of erroneous and/or outdated information from 
other Agency files.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment on this 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by February 27, 2017.

ADDRESSES: You may submit comments as follows:

[[Page 96014]]

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): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, 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-2014-D-1953 for ``Providing Regulatory Submissions in Electronic 
Format--Submission of Manufacturing Establishment Information.'' 
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 Division of Dockets Management 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 Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    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 Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    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; or 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. 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: Regarding drug products: Karen 
Takahashi, Center for Drug Evaluation and Research, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 4244, Silver 
Spring, MD 20993-0002, 301-796-3191.
    Regarding biological products: Stephen Ripley, Center for Biologics 
Evaluation and Research, Food and Drug Administration, 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 ``Providing Regulatory Submissions in Electronic Format--
Submission of Manufacturing Establishment Information.''
    This draft guidance discusses the requirements and implementation 
of section 745A(a) of the FD&C Act (21 U.S.C. 379k-1) regarding valid 
electronic submissions of MEI. Twenty-four months after this draft has 
been finalized, MEI contained in new drug applications (NDAs), 
abbreviated new drug applications (ANDAs), biologics license 
applications (BLAs), and amendments, supplements, or resubmissions of 
these application types must be submitted electronically in the format 
specified in this guidance. This draft guidance also applies to drug 
master files that are submitted for incorporation by reference into an 
NDA, ANDA, or BLA.
    Under current regulations at 21 CFR 314.50(d) and 21 CFR 601.2(a), 
applicants and holders of approved applications are required to submit 
contact information for each manufacturing establishment involved in 
the manufacture of the drug or biological product, as well as other 
information relating to the manufacture of the product. This 
information is part of the existing application form (FDA Form 356h, 
``Application to Market a New Drug, Biologic, or an Antibiotic Drug for 
Human Use''). We have found that the MEI is sometimes incomplete, and 
scattered throughout electronic submissions. This can lead to delays in 
application processing.
    The Agency is requiring that applicants submit a single, 
consolidated list of information about each manufacturing establishment 
mentioned in any application. This information must include the name 
and address of each manufacturing establishment involved in the 
manufacture of the drug or biological product, specific information 
regarding the physical location of the establishment, facility 
identifiers assigned to the establishment by FDA, contact information 
for the person responsible for scheduling inspections at the 
establishment, and

[[Page 96015]]

the specific manufacturing operations conducted at the establishment.
    We believe the required electronic MEI can be consolidated to 
appear in a single location to facilitate the complete, timely, and 
accurate review of all manufacturing establishments involved in the 
preparation of a drug or biological product. This will help to 
eliminate the inclusion and/or maintenance of potentially outdated and 
erroneous information that could be retrieved from other Agency files 
and will enable proper identification and timely evaluation of 
manufacturing establishments for conformance with requirements, 
including current good manufacturing practices.

II. Paperwork Reduction Act of 1995

    The guidance refers to previously approved collections of 
information that are subject to review by the Office of Management and 
Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520). The draft guidance discusses the electronic submission of MEI 
contained in an NDA, ANDA, or BLA to the Center for Drug Evaluation and 
Research and the Center for Biologics Evaluation and Research by 
specifying the format for the electronic submission of such 
submissions. The information collection discussed in the guidance is 
contained in our NDA and ANDA regulations (part 314) and approved under 
OMB control number 0910-0001, and our BLA regulations (part 601) and 
approved under OMB control number 0910-0338. Currently, MEI is 
submitted as part of the existing application form, Form FDA 356h, and 
is approved by OMB under control number 0910-0338.

III. Electronic Access

    Persons with access to the Internet may obtain the document at 
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, or https://www.regulations.gov.

    Dated: December 23, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-31626 Filed 12-28-16; 8:45 am]
 BILLING CODE 4164-01-P