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--- schema: federal-register doc_type: fedreg source_file: FR-2017-11-17.xml --- 82 221 Friday, November 17, 2017 Contents Agriculture Agriculture Department See Forest Service NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 54316 2017-24940 Consumer Financial Protection Bureau of Consumer Financial Protection RULES Payday, Vehicle Title, and Certain High-Cost Installment Loans, 54472-54921 2017-21808 Census Bureau Census Bureau NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals: American Community Survey Methods Panel Tests, 54317-54320 2017-24943 Centers Medicare Centers for Medicare & Medicaid Services NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 54344-54345 2017-25008 Children Children and Families Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Community Services Block Grant State Plan Application, 54348 2017-24905 Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery, 54345-54346 2017-24902 Variations in Implementation of Quality Interventions Project, 54346-54348 2017-24901 Coast Guard Coast Guard PROPOSED RULES Anchorage Areas:

Captain of the Port Puget Sound Zone, WA; Withdrawal, 54307 2017-24942 Commerce Commerce Department See Census Bureau See Foreign-Trade Zones Board See International Trade Administration See National Oceanic and Atmospheric Administration Education Department Education Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Freedom of Information Act Third Party Perjury Form, 54337-54338 2017-24941 Gainful Employment Program—Subpart R—Cohort Default Rates, 54337 2017-24978 Gainful Employment Program—Subpart Q—Appeals for Debt to Earnings Rates, 54336-54337 2017-24977 Gainful Employment Programs—Subpart Q, 54335-54336 2017-24976 Employment and Training Employment and Training Administration NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals: Workforce Flexibility Plan Submission and Reporting Requirements, 54414-54415 2017-24998 Energy Department Energy Department See Federal Energy Regulatory Commission Environmental Protection Environmental Protection Agency RULES Air Quality State Implementation Plans; Approvals and Promulgations: Iowa; Elements of the Infrastructure SIP Requirements for the 2010 Nitrogen Dioxide National Ambient Air Quality Standard; Withdrawal, 54299 2017-24891 Iowa;

Elements of the Infrastructure SIP Requirements for the 2010 Sulfur Dioxide National Ambient Air Quality Standard; Withdrawal, 54300 2017-24903 Kansas; Construction Permits and Approvals Program; Withdrawal, 54300 2017-24894 Maryland; 2011 Base Year Inventory for the 2008 8-Hour Ozone National Ambient Air Quality Standard for the Maryland Portion of the Philadelphia-Wilmington-Atlantic City Nonattainment Area; Withdrawal, 54298-54299 2017-24885 Maryland; Direct Final Rule for the Approval of an Alternative Volatile Organic Compound Emission Standard;

Withdrawal, 54300-54301 2017-24889 Nebraska; Infrastructure SIP Requirements for the 2010 Nitrogen Dioxide and Sulfur Dioxide and the 2012 Fine Particulate Matter National Ambient Air Quality Standards; Withdrawal, 54299 2017-24893 PROPOSED RULES Air Quality State Implementation Plans; Approvals and Promulgations: California Air Plan Revisions, Mojave Desert Air Quality Management District, 54307-54314 2017-25015 2017-25017 NOTICES Adequacy Status: Motor Vehicle Emissions Budgets in Submitted Reasonable Further Progress Plan for San Diego 8-hour Ozone for Transportation Conformity Purposes;

California, 54339-54340 2017-25020 Agency Information Collection Activities; Proposals, Submissions, and Approvals: SmartWay Transport Partnership, 54338-54339 2017-24971 Environmental Impact Statements; Availability, etc., 54340 2017-24973 Equal Equal Employment Opportunity Commission NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 54340-54341 2017-24979 Federal Aviation Federal Aviation Administration PROPOSED RULES Airworthiness Directives:

Bombardier, Inc., Airplanes, 54304-54306 2017-24814 The Boeing Company Airplanes, 54302-54304 2017-24809 Federal Communications Federal Communications Commission RULES Television Broadcasting Services: Anchorage, AK, 54301 2017-24944 Federal Emergency Federal Emergency Management Agency NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Revisions to National Flood Insurance Program Maps: Application Forms and Instructions for (C)LOMAs and (C)LOMR-Fs, 54402-54403 2017-24968 Disaster Declarations:

Alabama; Amendment 1, 54403-54404 2017-24970 Meetings: Technical Mapping Advisory Council, 54402 2017-24969 Federal Energy Federal Energy Regulatory Commission NOTICES Combined Filings, 54338 2017-24988 Federal Maritime Federal Maritime Commission NOTICES Petitions for Exemptions: COSCO Shipping Lines Co., Ltd., Orient Overseas Container Line Limited, and OOCL (Europe) Limited, 54341-54342 2017-25007 Federal Trade Federal Trade Commission NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals, 54342-54344 2017-24915 Fish Fish and Wildlife Service NOTICES Import Permits: Zimbabwe Elephant Trophies Taken On or After January 21, 2016, and On or Before December 31, 2018, 54405-54408 2017-24974 Food and Drug Food and Drug Administration RULES Guidance: Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use, 54290-54292 2017-24838 Same Surgical Procedure Exception:

Questions and Answers Regarding the Scope of the Exception, 54289-54290 2017-24839 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Food and Drug Administration Recall Regulations, 54359-54361 2017-24923 Generic Clearance for the Collection of Qualitative Data on Tobacco Products and Communications, 54351-54353 2017-24924 Guidance for Industry, Researchers, Patient Groups, and Food and Drug Administration Staff on Meetings With the Office of Orphan Products Development, 54357-54359 2017-24926 Premarket Notification for a New Dietary Ingredient, 54355-54357 2017-24925 Emergency Use Authorizations:

In Vitro Diagnostic Devices for Detection of Zika Virus, 54361-54385 2017-25010 Guidance: Controlled Correspondence Related to Generic Drug Development; Correction, 54386-54387 2017-24948 Evaluation of Devices Used With Regenerative Medicine Advanced Therapies, 54349-54351 2017-24836 Expedited Programs for Regenerative Medicine Therapies for Serious Conditions, 54385-54386 2017-24837 Unique Device Identification: Direct Marking of Devices, 54387-54388 2017-24992 Meetings: Cardiac Troponin Assays;

Public Workshop, 54348-54349 2017-24922 Medical Gas Regulation; Public Workshops, 54353-54355 2017-24918 Foreign Assets Foreign Assets Control Office NOTICES Blocking or Unblocking of Persons and Properties, 54466-54469 2017-24947 2017-24954 Foreign Trade Foreign-Trade Zones Board NOTICES Proposed Production Activities: Estee Lauder Inc., Foreign-Trade Zone 52, Suffolk County, NY, 54320 2017-24972 Forest Forest Service NOTICES Meetings: Black Hills National Forest Advisory Board, 54316-54317 2017-24914 Health and Human Health and Human Services Department See Centers for Medicare & Medicaid Services See Children and Families Administration See Food and Drug Administration See National Institutes of Health See Substance Abuse and Mental Health Services Administration PROPOSED RULES Foreign Quarantine Regulations, Proposed Revision of HHS/CDC Animal Importation Regulations, 54314 2017-24951 Possession, Use, and Transfer of Select Agents and Toxins:

Addition of Certain Influenza Virus Strains to the List of Select Agents and Toxins, 54314-54315 2017-24952 Total Inward Leakage Requirements for Respirators, 54315 2017-24950 Historic Historic Preservation, Advisory Council NOTICES Proposed Draft Program Comment to Exempt Effects of Transportation-Related Undertakings within Rail Rights-of-Way, 54390-54402 2017-25025 Homeland Homeland Security Department See Coast Guard See Federal Emergency Management Agency See Transportation Security Administration Housing Housing and Urban Development Department NOTICES Revocation of Orders of Succession for the Office of the Deputy Secretary, 54404-54405 2017-25024 Institute of Museum and Library Services Institute of Museum and Library Services NOTICES Meetings;

Sunshine Act, 54420 2017-25108 Interior Interior Department See Fish and Wildlife Service See Land Management Bureau See Surface Mining Reclamation and Enforcement Office International Trade Adm International Trade Administration NOTICES Antidumping or Countervailing Duty Investigations, Orders, or Reviews: Certain Steel Nails from the Socialist Republic of Vietnam, 54320-54321 2017-24967 Light-Walled Rectangular Pipe and Tube from Mexico, 54322-54324 2017-24965 Narrow Woven Ribbon with Woven Selvedge from the People's Republic of China, 54325-54326 2017-24966 Steel Wire Garment Hangers from the People's Republic of China, 54324-54325 2017-24964 Meetings:

Summit on Trade-Related Standards Issues, 54321-54322 2017-24605 International Trade Com International Trade Commission NOTICES Complaints: Certain Microperforated Packaging Containing Fresh Produce, 54411-54412 2017-24921 Investigations; Determinations, Modifications, and Rulings, etc.: Certain Mobile Device Holders and Components Thereof, 54413-54414 2017-24927 Tin- and Chromium-Coated Steel Sheet from Japan, 54412 2017-24980 Labor Department Labor Department See Employment and Training Administration See Labor Statistics Bureau See Mine Safety and Health Administration NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals: Hazard Communication Standard, 54416 2017-24994 Meetings: Labor Advisory Committee for Trade Negotiation and Trade Policy, 54415-54416 2017-25011 Labor Statistics Labor Statistics Bureau NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 54416-54419 2017-24996 2017-24997 Land Land Management Bureau NOTICES Environmental Impact Statements; Availability, etc.: Draft Ray Land Exchange/Plan Amendment, AZ, 54408-54409 2017-24823 Records of Decisions:

Boardman to Hemingway Transmission Line Project and Approved Land-use Plan Amendments, Oregon, 54409-54411 2017-25013 Merit Merit Systems Protection Board NOTICES FY 2015 Service Contract Inventory, 54420 2017-24904 Mine Mine Safety and Health Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Permissible Equipment Testing, 54419-54420 2017-24995 National Foundation National Foundation on the Arts and the Humanities See Institute of Museum and Library Services National Institute National Institutes of Health NOTICES Meetings:

National Cancer Institute, 54389-54390 2017-24895 National Heart, Lung, and Blood Institute, 54388-54389 2017-24896 2017-24897 National Institute of Mental Health, 54388 2017-24899 National Institute on Alcohol Abuse and Alcoholism, 54389 2017-24898 National Oceanic National Oceanic and Atmospheric Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 54330-54332 2017-24989 2017-24990 Agency Information Collection Activities; Proposals, Submissions, and Approvals:

Alaska Commercial Operator's Annual Report, 54335 2017-24991 Endangered Species: File Nos. 20590 and 20610, 54334-54335 2017-24946 Meetings: Caribbean Fishery Management Council, 54331-54332 2017-24958 Mid-Atlantic Fishery Management Council, 54334 2017-24956 New England Fishery Management Council, 54329-54331, 54333-54334 2017-24957 2017-24959 2017-24961 North Pacific Fishery Management Council, 54332-54333 2017-24962 South Atlantic Fishery Management Council, 54327-54329 2017-24955 Western Pacific Fishery Management Council, 54326-54327 2017-24960 National Science National Science Foundation NOTICES Meetings:

Advisory Committee for Integrative Activities, 54420-54421 2017-24993 Nuclear Regulatory Nuclear Regulatory Commission NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Licenses and Radiation Safety Requirements for Irradiators, 54421-54422 2017-24987 Pipeline Pipeline and Hazardous Materials Safety Administration NOTICES Hazardous Materials: Proposed Termination of M-Number and R-Number Approvals Issued Without an Expiration Date, 54465-54466 2017-24981 Postal Regulatory Postal Regulatory Commission NOTICES New Postal Products, 54422 2017-24906 Presidential Documents Presidential Documents PROCLAMATIONS Special Observances:

Vietnam War; Commemoration of the 50th Anniversary (Proc. 9674), 55023-55026 2017-25164 Securities Securities and Exchange Commission NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 54422-54423 2017-24945 Petitions: Virtu Financial Inc., Virtu Americas, LLC; Susquehanna International Group, et al., 54439-54440 2017-24939 Self-Regulatory Organizations; Proposed Rule Changes: Cboe EDGA Exchange, Inc., 54440-54441 2017-24933 Cboe EDGX Exchange, Inc., 54442-54448, 54453-54455 2017-24929 2017-24932 2017-24936 ICE Clear Europe Limited, 54423-54425 2017-24935 Investors Exchange, LLC, 54425-54430 2017-24930 Municipal Securities Rulemaking Board, 54455-54457 2017-24928 Nasdaq BX, Inc., 54460-54463 2017-24931 NYSEArca, Inc., 54434-54437 2017-24938 The Nasdaq Stock Market LLC, 54437-54439, 54457-54460 2017-24934 2017-24937 The Options Clearing Corp., 54430-54434, 54448-54453 2017-24919 2017-24920 Small Business Small Business Administration NOTICES Major Disaster Declarations:

Puerto Rico; Amendment 4, 54463 2017-24916 State Department State Department NOTICES Investigations; Determinations, Modifications, and Rulings, etc.: Central Government of Nicaragua, 54463 2017-24963 Substance Substance Abuse and Mental Health Services Administration NOTICES Meetings: Interdepartmental Serious Mental Illness Coordinating Committee, 54390 2017-24876 Surface Mining Surface Mining Reclamation and Enforcement Office RULES Congressional Nullification of the Stream Protection Rule under the Congressional Review Act, 54924-55022 2017-24307 Texas Regulatory Program, 54292-54295 2017-24620 Surface Transportation Surface Transportation Board NOTICES Discontinuance of Service Exemptions:

CSX Transportation, Inc. in Dickenson County, VA, 54463-54464 2017-24900 Susquehanna Susquehanna River Basin Commission NOTICES Projects Approved for Consumptive Uses of Water, 54464 2017-24985 Projects Approved for Minor Modifications, 54464-54465 2017-24984 Projects Rescinded: Consumptive Uses of Water, 54465 2017-24986 Transportation Department Transportation Department See Federal Aviation Administration See Pipeline and Hazardous Materials Safety Administration Security Transportation Security Administration NOTICES Meetings:

Aviation Security Advisory Committee, 54404 2017-24917 Treasury Treasury Department See Foreign Assets Control Office Veteran Affairs Veterans Affairs Department RULES Vocational Rehabilitation and Employment Nomenclature Change for Position Title, 54295-54298 2017-24949 NOTICES Meetings: National Academic Affiliations Council, 54469 2017-25009 Separate Parts In This Issue Part II Bureau of Consumer Financial Protection, 54472-54921 2017-21808 Part III Interior Department, Surface Mining Reclamation and Enforcement Office, 54924-55022 2017-24307 Part IV Presidential Documents, 55023-55026 2017-25164 Reader Aids Consult the Reader Aids section at the end of this issue for phone numbers, online resources, finding aids, and notice of recently enacted public laws.

To subscribe to the Federal Register Table of Contents electronic mailing list, go to https://public.govdelivery.com/accounts/USGPOOFR/subscriber/new, enter your e-mail address, then follow the instructions to join, leave, or manage your subscription. 82 221 Friday, November 17, 2017 Rules and Regulations DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 1271 [Docket No. FDA-2014-D-1584] Same Surgical Procedure Exception: Questions and Answers Regarding the Scope of the Exception;

Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notification of availability. SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a document entitled “Same Surgical Procedure Exception under 21 CFR 1271.15(b): Questions and Answers Regarding the Scope of the Exception.” The guidance document provides tissue establishments and health care professionals with FDA's current thinking on the scope of an exception set forth in the human cells, tissues, and cellular and tissue-based products (HCT/Ps) regulations.

DATES: The announcement of the guidance is published in the **Federal Register** on November 17, 2017. 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, 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-2014-D-1584 for “Same Surgical Procedure Exception under 21 CFR 1271.15(b): Questions and Answers Regarding the Scope of the Exception.” 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 guidance to the Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research (CBER), 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 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 guidance document. FOR FURTHER INFORMATION CONTACT: Lori J. Churchyard, 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 document entitled “Same Surgical Procedure Exception under 21 CFR 1271.15(b): Questions and Answers Regarding the Scope of the Exception.

” The guidance provides tissue establishments and health care professionals with FDA's current thinking on the scope of the exception set forth in part 1271 (21 CFR part 1271), specifically the exception set forth in § 1271.15(b) (21 CFR 1271.15(b)). This guidance does not address the other exceptions in § 1271.15. The guidance, presented in question and answer format, provides FDA's current interpretation of this regulation and includes examples based on inquiries received by the Agency since the final rule entitled “Human Cells, Tissues, and Cellular and Tissue-Based Products;

Establishment Registration and Listing” published in the **Federal Register** of January 19, 2001 (66 FR 5447). In the **Federal Register** of October 23, 2014 (79 FR 63348), FDA announced the availability of the draft guidance of the same title. Additionally, in the **Federal Register** of December 24, 2014 (79 FR 77414), FDA announced the availability of the draft guidance entitled “Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) from Adipose Tissue: Regulatory Considerations;

Draft Guidance for Industry” dated December 2014 (Adipose Draft Guidance). In the **Federal Register** of October 30, 2015, FDA reopened the comment period for three HCT/P-related draft guidances (80 FR 66847, 66849, and 66844, respectively) and announced the availability of another HCT/P-related draft guidance (80 FR 66850). Comments on the four HCT/P-related guidances were requested by April 29, 2016. Lastly, in the **Federal Register** of October 30, 2015 (80 FR 66845), FDA announced a 1-day part 15 (21 CFR part 15) public hearing to obtain input on the four HCT/P-related guidances to be held on April 13, 2016.

Due to considerable interest in the public hearing and to give stakeholders additional time to provide comments to the Agency, on February 29, 2016, FDA announced that the hearing was postponed. In the **Federal Register** of April 22, 2016 (81 FR 23661 and 81 FR 23664, respectively), FDA announced the rescheduled part 15 hearing date of September 12 and 13, 2016, and an extension of the comment period from April 29, 2016, until September 27, 2016, on the four HCT/P-related guidances.

Also in the **Federal Register** of April 22, 2016 (81 FR 23708), FDA announced a public workshop to be held on September 8, 2016, on the “Scientific Evidence in Development of HCT/Ps Subject to Premarket Approval.” FDA received numerous comments on the draft guidance and the Adipose Draft Guidance in response to the request for comments, and those comments were considered in developing the final guidance. The guidance announced in this notification finalizes the draft guidance of the same title dated October 2014.

This guidance also finalizes certain material related to adipose tissue that was included in the Adipose Draft Guidance. The material in this guidance related to adipose tissue, together with the material in the final guidance entitled “Regulatory Considerations for Human Cell, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use; Guidance for Industry and Food and Drug Administration Staff” dated November 2017 (Minimal Manipulation and Homologous Use Guidance) related to adipose tissue, supersedes the Adipose Draft Guidance.

Accordingly, FDA does not intend to finalize the Adipose Draft Guidance, which is now withdrawn. Elsewhere in this issue of the **Federal Register** , FDA is announcing the availability of the Minimal Manipulation and Homologous Use 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 “Same Surgical Procedure Exception under 21 CFR 1271.15(b): Questions and Answers Regarding the Scope of the Exception.

” 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. Paperwork Reduction Act of 1995 The guidance refers to previously approved collections of information found in FDA regulations. 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 part 1271 have been approved under OMB control number 0910-0543. III. Electronic Access Persons with access to the internet may obtain the guidance at either *https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm* or *https://www.regulations.gov* . Dated: November 13, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-24839 Filed 11-16-17; 8:45 am]

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