Metal Expandable Biliary Stents-Premarket Notification (510(k)) Submissions; Guidance for Industry and Food and Drug Administration Staff; Availability, 36105-36107 [2019-15889]

Download as PDF 36105 Federal Register / Vol. 84, No. 144 / Friday, July 26, 2019 / Notices TABLE 4—FEE SCHEDULE FOR FY 2020—Continued Fees rates for FY 2020 Fee category Facilities: Active Pharmaceutical Ingredient (API) Domestic ....................................................................................................................... API—Foreign ................................................................................................................................................................................ Finished Dosage Form (FDF)—Domestic .................................................................................................................................... FDF—Foreign ............................................................................................................................................................................... Contract Manufacturing Organization (CMO)—Domestic ............................................................................................................ CMO—Foreign .............................................................................................................................................................................. GDUFA Program: Large size operation generic drug applicant ................................................................................................................................ Medium size operation generic drug applicant ............................................................................................................................ Small business operation generic drug applicant ........................................................................................................................ jbell on DSK3GLQ082PROD with NOTICES X. Fee Payment Options and Procedures The new fee rates are effective October 1, 2019. To pay the ANDA, DMF, API facility, FDF facility, CMO facility, and GDUFA program fees, a Generic Drug User Fee Cover Sheet must be completed, available at https:// www.fda.gov/gdufa and https:// userfees.fda.gov/OA_HTML/gdufaCA cdLogin.jsp, and a user fee identification (ID) number must be generated. Payment must be made in U.S. currency drawn on a U.S. bank by electronic check, check, bank draft, U.S. postal money order, credit card, or wire transfer. The preferred payment method is online using electronic check (Automated Clearing House (ACH), also known as eCheck) or credit card (Discover, VISA, MasterCard, American Express). FDA has partnered with the U.S. Department of the Treasury to utilize Pay.gov, a web-based payment application, for online electronic payment. The Pay.gov feature is available on the FDA website after completing the Generic Drug User Fee Cover Sheet and generating the user fee ID number. Secure electronic payments can be submitted using the User Fees Payment Portal at https://userfees.fda.gov/pay. (Note: Only full payments are accepted; no partial payments can be made online.) Once an invoice is located, ‘‘Pay Now’’ should be selected to be redirected to Pay.gov. Electronic payment options are based on the balance due. Payment by credit card is available for balances less than $25,000. If the balance exceeds this amount, only the ACH option is available. Payments must be made using U.S bank accounts as well as U.S. credit cards. The user fee ID number must be included on the check, bank draft, or postal money order and must be made payable to the order of the Food and Drug Administration. Payments can be mailed to: Food and Drug VerDate Sep<11>2014 17:54 Jul 25, 2019 Jkt 247001 Administration, P.O. Box 979108, St. Louis, MO 63197–9000. If checks are to be sent by a courier that requests a street address, the courier can deliver checks to: U.S. Bank, Attention: Government Lockbox 979108, 1005 Convention Plaza, St. Louis, MO 63101. (Note: This U.S. Bank address is for courier delivery only. For questions concerning courier delivery, U.S. Bank can be contacted at 314–418–4013. This telephone number is only for questions about courier delivery.) The FDA post office box number (P.O. Box 979108) must be written on the check, bank draft, or postal money order. For payments made by wire transfer, the unique user fee ID number must be referenced. Without the unique user fee ID number, the payment may not be applied. If the payment amount is not applied, the invoice amount will be referred to collections. The originating financial institution may charge a wire transfer fee. Applicable wire transfer fees must be included with payment to ensure fees are fully paid. Questions about wire transfer fees should be addressed to the financial institution. The following account information should be used to send payments by wire transfer: U.S. Department of the Treasury, TREAS NYC, 33 Liberty St., New York, NY 10045, account number: 75060099, routing number: 021030004, SWIFT: FRNYUS33. FDA’s tax identification number is 53–0196965. Dated: July 23, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2019–15906 Filed 7–25–19; 8:45 am] BILLING CODE 4164–01–P PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 44,400 59,400 195,662 210,662 65,221 80,221 1,661,684 664,674 166,168 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2018–D–1771] Metal Expandable Biliary Stents— Premarket Notification (510(k)) Submissions; 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 final guidance entitled ‘‘Metal Expandable Biliary Stents—Premarket Notification (510(k)) Submissions.’’ This guidance provides recommendations for information and testing that should be included in 510(k) submissions for metal expandable biliary stents and their associated delivery systems intended to provide luminal patency of malignant strictures in the biliary tree. DATES: The announcement of the guidance is published in the Federal Register on July 26, 2019. ADDRESSES: You may submit either electronic or written comments on Agency guidances 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, E:\FR\FM\26JYN1.SGM 26JYN1 36106 Federal Register / Vol. 84, No. 144 / Friday, July 26, 2019 / Notices jbell on DSK3GLQ082PROD with NOTICES 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– 2018–D–1771 for ‘‘Metal Expandable Biliary Stents—Premarket Notification (510(k)) Submissions.’’ 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 VerDate Sep<11>2014 17:54 Jul 25, 2019 Jkt 247001 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)). An electronic copy of the guidance document is available for download from the internet. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. Submit written requests for a single hard copy of the guidance document entitled ‘‘Metal Expandable Biliary Stents—Premarket Notification (510(k)) Submissions’’ to the Office of Policy, Guidance and Policy Development, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993–0002. Send one selfaddressed adhesive label to assist that office in processing your request. FOR FURTHER INFORMATION CONTACT: April Marrone, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. G218, Silver Spring, MD 20993–0002, 240–402–6510. SUPPLEMENTARY INFORMATION: I. Background This guidance provides recommendations for 510(k) submissions for metal expandable biliary stents and their associated delivery systems. These devices are intended to provide luminal patency of malignant strictures in the biliary tree. The scope of this guidance is limited to metal expandable biliary stents regulated under 21 CFR 876.5010 (Biliary catheter and accessories) and with product code FGE (Catheter, Biliary, Diagnostic). This guidance applies only to biliary stents indicated for palliation of malignant strictures in the biliary tree. It does not apply to PO 00000 Frm 00058 Fmt 4703 Sfmt 4703 biliary stents indicated to treat benign strictures or stents intended to be used in the vasculature, tracheal/bronchial tubes, or other gastrointestinal anatomy. FDA considered comments received on the draft guidance that appeared in the Federal Register of July 18, 2018 (83 FR 33940). FDA revised the guidance as appropriate in response to the comments. This guidance updates and supersedes the guidance ‘‘Guidance for the Content of Premarket Notifications for Metal Expandable Biliary Stents,’’ issued on February 5, 1998, to reflect current review practices. II. Significance of Guidance This guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on ‘‘Metal Expandable Biliary Stents—Premarket Notification (510(k)) Submissions.’’ 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. III. Electronic Access Persons interested in obtaining a copy of the guidance may do so by downloading an electronic copy from the internet. A search capability for all Center for Devices and Radiological Health guidance documents is available at https://www.fda.gov/medical-devices/ device-advice-comprehensiveregulatory-assistance/guidancedocuments-medical-devices-andradiation-emitting-products. This guidance document is also available at https://www.regulations.gov. Persons unable to download an electronic copy of ‘‘Metal Expandable Biliary Stents— Premarket Notification (510(k)) Submissions’’ may send an email request to CDRH-Guidance@fda.hhs.gov to receive an electronic copy of the document. Please use the document number 1500070 to identify the guidance you are requesting. IV. Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information. These collections of information 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 collections of information in the following FDA regulations have been approved by OMB as listed in the following table: E:\FR\FM\26JYN1.SGM 26JYN1 Federal Register / Vol. 84, No. 144 / Friday, July 26, 2019 / Notices 21 CFR part Topic 807, subpart E ............... 812 ................................ 801 ................................ 820 ................................ 50, 56 ............................ 56 .................................. Premarket Notification ....................................................................................................................... Investigational Device Exemption ...................................................................................................... Medical Device Labeling Regulations ............................................................................................... Current Good Manufacturing Practice (CGMP); Quality System (QS) Regulation ........................... Protection of Human Subjects: Informed Consent; Institutional Review Boards .............................. Institutional Review Boards ............................................................................................................... Dated: July 22, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2019–15889 Filed 7–25–19; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Rural Communities Opioid Response Program Performance Measures, OMB No. 0906-xxxx, New. Health Resources and Services Administration (HRSA), Department of Health and Human Services. ACTION: Notice. AGENCY: jbell on DSK3GLQ082PROD with NOTICES SUMMARY: In compliance with of the Paperwork Reduction Act of 1995, HRSA has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period. DATES: Comments on this ICR should be received no later than August 26, 2019. ADDRESSES: Submit your comments, including the ICR title, to the desk officer for HRSA, either by email to OIRA_submission@omb.eop.gov or by fax to (202) 395–5806. FOR FURTHER INFORMATION CONTACT: To request a copy of the clearance requests submitted to OMB for review, email Lisa Wright-Solomon, the HRSA Information Collection Clearance Officer at paperwork@hrsa.gov or call (301) 443– 1984. VerDate Sep<11>2014 17:54 Jul 25, 2019 Jkt 247001 OMB Control No. SUPPLEMENTARY INFORMATION: Information Collection Request Title: Rural Communities Opioid Response Program Performance Measures, OMB No. 0906-xxxx, New Abstract: The Rural Communities Opioid Response Program (RCORP) is a multi-initiative program that aims to: (1) Support treatment for, and prevention of, substance use disorder (SUD), including opioid use disorder (OUD); and (2) reduce morbidity and mortality associated with SUD, to include OUD, by improving access to prevention, treatment, and recovery support services to high-risk rural communities. To support this purpose, RCORP grant initiatives include: • RCORP-Planning grants to strengthen the capacity of multi-sector consortia to collaborate and develop plans to deliver SUD/OUD prevention, treatment, and recovery services in high-risk rural communities; • RCORP-Implementation grants to fund established networks and consortia to deliver SUD/OUD prevention, treatment, and recovery activities in high-risk rural communities; and • RCORP-Medication Assisted Treatment Expansion grants to enhance access to medication-assisted treatment within eligible hospitals, health clinics, or tribal organizations in high-risk rural communities. Additionally, all RCORP grant award recipients will be supported by five cooperative agreements: RCORPTechnical Assistance, which provides extensive technical assistance to award recipients; RCORP-Evaluation, which will evaluate the impact of the RCORP initiative on rural communities; and three RCORP-Rural Centers of Excellence in Substance Use Disorders, which will disseminate best practices related to the treatment for, and prevention of, SUD within rural communities. A 60-day notice was published in the Federal Register on PO 00000 Frm 00059 Fmt 4703 Sfmt 4703 36107 0910–0120 0910–0078 0910–0485 0910–0073 0910–0755 0910–0130 April 12, 2019, vol. 84, No. 71; pp. 14949–14950. There were no public comments. Need and Proposed Use of the Information: For this program, performance measures were developed to provide data on each RCORP initiative and to enable HRSA to provide aggregate program data required by Congress under the Government Performance and Results Act of 1993. These measures cover the principal topic areas of interest to the Federal Office of Rural Health Policy (FORHP), including: (a) Provision of, and referral to, SUD treatment and support services; (b) SUD prevention, treatment, and recovery process and outcomes; (c) education of health care providers and community members; (d) number of fatal and non-fatal opioid-related overdoses; and (e) consortium strength and sustainability. All measures will speak to FORHP’s progress toward meeting the goals set. Likely Respondents: The respondents will be the grant award recipients of RCORP initiatives. Burden Statement: Burden in this context means the time expended by persons to generate, maintain, retain, disclose or provide the information requested. This includes the time needed to review instructions; to develop, acquire, install, and utilize technology and systems for the purpose of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; to train personnel and to be able to respond to a collection of information; to search data sources; to complete and review the collection of information; and to transmit or otherwise disclose the information. The total annual burden hours estimated for this ICR are summarized in the table below. E:\FR\FM\26JYN1.SGM 26JYN1

Agencies

[Federal Register Volume 84, Number 144 (Friday, July 26, 2019)]
[Notices]
[Pages 36105-36107]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-15889]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-1771]


Metal Expandable Biliary Stents--Premarket Notification (510(k)) 
Submissions; 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 final guidance entitled ``Metal Expandable 
Biliary Stents--Premarket Notification (510(k)) Submissions.'' This 
guidance provides recommendations for information and testing that 
should be included in 510(k) submissions for metal expandable biliary 
stents and their associated delivery systems intended to provide 
luminal patency of malignant strictures in the biliary tree.

DATES: The announcement of the guidance is published in the Federal 
Register on July 26, 2019.

ADDRESSES: You may submit either electronic or written comments on 
Agency guidances 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,

[[Page 36106]]

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-2018-D-1771 for ``Metal Expandable Biliary Stents--Premarket 
Notification (510(k)) Submissions.'' 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)).
    An electronic copy of the guidance document is available for 
download from the internet. See the SUPPLEMENTARY INFORMATION section 
for information on electronic access to the guidance. Submit written 
requests for a single hard copy of the guidance document entitled 
``Metal Expandable Biliary Stents--Premarket Notification (510(k)) 
Submissions'' to the Office of Policy, Guidance and Policy Development, 
Center for Devices and Radiological Health, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver 
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist 
that office in processing your request.

FOR FURTHER INFORMATION CONTACT: April Marrone, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. G218, Silver Spring, MD 20993-0002, 240-402-6510.

SUPPLEMENTARY INFORMATION:

I. Background

    This guidance provides recommendations for 510(k) submissions for 
metal expandable biliary stents and their associated delivery systems. 
These devices are intended to provide luminal patency of malignant 
strictures in the biliary tree. The scope of this guidance is limited 
to metal expandable biliary stents regulated under 21 CFR 876.5010 
(Biliary catheter and accessories) and with product code FGE (Catheter, 
Biliary, Diagnostic). This guidance applies only to biliary stents 
indicated for palliation of malignant strictures in the biliary tree. 
It does not apply to biliary stents indicated to treat benign 
strictures or stents intended to be used in the vasculature, tracheal/
bronchial tubes, or other gastrointestinal anatomy.
    FDA considered comments received on the draft guidance that 
appeared in the Federal Register of July 18, 2018 (83 FR 33940). FDA 
revised the guidance as appropriate in response to the comments. This 
guidance updates and supersedes the guidance ``Guidance for the Content 
of Premarket Notifications for Metal Expandable Biliary Stents,'' 
issued on February 5, 1998, to reflect current review practices.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
current thinking of FDA on ``Metal Expandable Biliary Stents--Premarket 
Notification (510(k)) Submissions.'' 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.

III. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by 
downloading an electronic copy from the internet. A search capability 
for all Center for Devices and Radiological Health guidance documents 
is available at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products. This guidance document is also 
available at https://www.regulations.gov. Persons unable to download an 
electronic copy of ``Metal Expandable Biliary Stents--Premarket 
Notification (510(k)) Submissions'' may send an email request to [email protected] to receive an electronic copy of the document. 
Please use the document number 1500070 to identify the guidance you are 
requesting.

IV. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information. These collections of information 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 collections of information in 
the following FDA regulations have been approved by OMB as listed in 
the following table:

[[Page 36107]]



------------------------------------------------------------------------
          21 CFR part                   Topic           OMB Control No.
------------------------------------------------------------------------
807, subpart E................  Premarket                      0910-0120
                                 Notification.
812...........................  Investigational                0910-0078
                                 Device Exemption.
801...........................  Medical Device                 0910-0485
                                 Labeling Regulations.
820...........................  Current Good                   0910-0073
                                 Manufacturing
                                 Practice (CGMP);
                                 Quality System (QS)
                                 Regulation.
50, 56........................  Protection of Human            0910-0755
                                 Subjects: Informed
                                 Consent;
                                 Institutional Review
                                 Boards.
56............................  Institutional Review           0910-0130
                                 Boards.
------------------------------------------------------------------------


    Dated: July 22, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-15889 Filed 7-25-19; 8:45 am]
 BILLING CODE 4164-01-P
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