Federal Register / Vol. 80, No. 207 / Tuesday, October 27, 2015 / Notices 65779

Based on FDA’s review of current TABLE 1—Continued DeviceRegulationandGuidance/ scientific literature, FDA would not GuidanceDocuments/UCM080199.pdf. consider the determination of carrier Tyrosinemia Type I Dated: October 20, 2015. status by detection of clinically relevant Usher Syndrome Type 1F Usher Syndrome Type III Leslie Kux, associated with the Zellweger Syndrome Spectrum diseases and conditions listed in Table Associate Commissioner for Policy. [FR Doc. 2015–27198 Filed 10–26–15; 8:45 am] 1 to constitute a different intended use Exemption from the requirement of from that of a legally marketed device in premarket notification does not exempt BILLING CODE 4164–01–P the generic type 21 CFR 866.5940 for a device from other applicable purposes of § 866.9(a). Thus such uses regulatory controls under the FD&C Act, would be 510(k)-exempt once there is DEPARTMENT OF HEALTH AND including the applicable general and HUMAN SERVICES compliance with special controls. A special controls. Indeed, FDA’s decision gene detection system to propose 510(k) exemption for these Food and Drug Administration indicated for the determination of devices is based, in part, on the special carrier status by detection of clinically controls, in combination with general [Docket No. FDA–2015–N–3815] relevant gene mutations associated with controls, providing sufficiently rigorous Agency Information Collection Cystic Fibrosis is not 510(k)-exempt mitigations for the risks identified for since it is a class II device subject to Activities; Proposed Collection; this generic type. Comment Request; Electronic premarket notification and special Subject to the limitations described controls under 21 CFR 866.5900—Cystic Submission of Medical Device previously, FDA has determined that Registration and Listing fibrosis transmembrane conductance the requirement of premarket regulator (CFTR) gene mutation notification is not necessary to assure AGENCY: Food and Drug Administration, detection system. the safety and effectiveness of an HHS. autosomal recessive carrier screening ACTION: Notice of availability. TABLE 1 gene mutation detection system. Accordingly, FDA is announcing its SUMMARY: The Food and Drug Beta Thalassemia Administration (FDA) is announcing an Bloom Syndrome intent to exempt from the premarket notification requirements autosomal opportunity for public comment on the Canavan Disease proposed collection of certain Congenital Disorder of Glycosylation Type 1a recessive carrier screening gene (PMM2–CDG) mutation detection systems, subject to information by the Agency. Under the Autosomal Recessive Connexin 26- the limitations described previously. Paperwork Reduction Act of 1995 (the Nonsyndromic FDA is publishing this notice in order PRA), Federal Agencies are required to D-Bifunctional Protein Deficiency to obtain comments regarding the publish notice in the Federal Register Dihydrolipoamide Dehydrogenase Deficiency proposed exemption. concerning each proposed collection of Familial Dysautonomia information, including each proposed Familial Mediterranean Fever V. Paperwork Reduction Act of 1995 extension of an existing collection of Fanconi Anemia Group C information, and to allow 60 days for Gaucher Disease This notice refers to previously Glycogen Storage Disease Type 1 (1a and approved collections of information public comment in response to the 1b) found in FDA regulations. These notice. This notice solicits comments on Gracile Syndrome collections of information are subject to information collection associated with Hereditary Fructose Intolerance review by the Office of Management and electronic submission of medical device Junctional Epidermolysis Bullosa (LAMB3-re- Budget (OMB) under the Paperwork registration and listing. lated) Reduction Act of 1995 (44 U.S.C. 3501– DATES: Submit either electronic or Leigh Syndrome, French Canadian Type 3520). The collections of information in written comments on the collection of (LSFC) Autosomal Recessive Limb-girdle Muscular 21 CFR part 807, subpart, E have been information by December 28, 2015. Dystrophy approved under OMB control number ADDRESSES: You may submit comments Maple Syrup Urine Disease 0910–0120 and the collections of as follows: Medium-Chain Acyl-CoA Dehydrogenase information in 21 CFR parts 801 and (MCAD) Deficiency 809 have been approved under OMB Electronic Submissions Mucolipidosis IV control number 0910–0485. Submit electronic comments in the Autosomal Recessive Neuronal Ceroid following way: Lipofuscinosis (CLN5-related) VI. Reference • Federal eRulemaking Portal: http:// Autosomal Recessive Neuronal Ceroid The following reference is on display www.regulations.gov. Follow the Lipofuscinosis (PPT1-related) Niemann-Pick Disease—Type A in the Division of Dockets Management instructions for submitting comments. Nijmegen Breakage Syndrome (see ADDRESSES) and is available for Comments submitted electronically, Pendred Syndrome viewing by interested persons between including attachments, to http:// Phenylketonuria 9 a.m. and 4 p.m., Monday through www.regulations.gov will be posted to Autosomal Recessive Polycystic Dis- Friday; it is also available electronically the docket unchanged. Because your ease at http://www.regulations.gov. FDA has comment will be made public, you are Primary Hyperoxaluria Type 2 (PH2) verified the Web site address, as of the solely responsible for ensuring that your Rhizomelic Chondrodysplasia Punctata Type date this document publishes in the comment does not include any 1 (RCDP1) Federal Register, but Web sites are confidential information that you or a Sickle Cell Anemia subject to change over time. third party may not wish to be posted, Sjo¨gren-Larsson Syndrome 1. ‘‘Procedures for Class II Device such as medical information, your or Autosomal Recessive Spastic Ataxia of Exemptions from Premarket Notification, anyone else’s Social Security number, or Charlevoix-Saguenay (ARSACS) Guidance for Industry and CDRH Staff,’’ confidential business information, such Spinal Muscular Atrophy February 1998, available at http:// as a manufacturing process. Please note Tay Sachs Disease www.fda.gov/downloads/MedicalDevices/ that if you include your name, contact

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information, or other information that comments and you must identify this collection of information on identifies you in the body of your information as ‘‘confidential.’’ Any respondents, including through the use comments, that information will be information marked as ‘‘confidential’’ of automated collection techniques, posted on will not be disclosed except in when appropriate, and other forms of http://www.regulations.gov. accordance with 21 CFR 10.20 and other information technology. • If you want to submit a comment applicable disclosure law. For more Electronic Submission of Medical with confidential information that you information about FDA’s posting of Device Registration and Listing—21 do not wish to be made available to the comments to public dockets, see 80 FR CFR Part 807, Subparts A Through E; public, submit the comment as a 56469, September 18, 2015, or access OMB Control Number 0910–0625— written/paper submission and in the the information at: http://www.fda.gov/ Extension manner detailed (see ‘‘Written/Paper regulatoryinformation/dockets/ Submissions’’ and ‘‘Instructions’’). default.htm. Under section 510 of the Federal Docket: For access to the docket to Food, Drug, and Cosmetic Act (the Written/Paper Submissions read background documents or the FD&C Act) (21 U.S.C. 360) and part 807, Submit written/paper submissions as electronic and written/paper comments subparts A through D (21 CFR part 807, follows: received, go to http:// subparts A through D), medical device • Mail/Hand delivery/Courier (for www.regulations.gov and insert the establishment owners and operators are written/paper submissions): Division of docket number, found in brackets in the required to electronically submit Dockets Management (HFA–305), Food heading of this document, into the establishment registration and device and Drug Administration, 5630 Fishers ‘‘Search’’ box and follow the prompts listing information. Lane, Rm. 1061, Rockville, MD 20852. Complete and accurate registration • and/or go to the Division of Dockets For written/paper comments Management, 5630 Fishers Lane, Rm. and listing information is necessary to submitted to the Division of Dockets 1061, Rockville, MD 20852. accomplish a number of statutory and Management, FDA will post your regulatory objectives, such as: (1) FOR FURTHER INFORMATION CONTACT: comment, as well as any attachments, FDA PRA Staff, Office of Operations, Food Identification of establishments except for information submitted, producing marketed medical devices, and Drug Administration, 8455 marked and identified, as confidential, (2) identification of establishments Colesville Rd., COLE–14526, Silver if submitted as detailed in producing a specific device when that Spring, MD 20993–0002, PRAStaff@ ‘‘Instructions.’’ device is in short supply or is needed fda.hhs.gov. Instructions: All submissions received for national emergency, (3) facilitation must include the Docket No. FDA– SUPPLEMENTARY INFORMATION: Under the of recalls for devices marketed by 2015–N–3815 for ‘‘Agency Information PRA (44 U.S.C. 3501–3520), Federal owners and operators of device Collection Activities; Proposed Agencies must obtain approval from the establishments, (4) identification and Collection; Comment Request; Office of Management and Budget cataloguing of marketed devices, (5) Electronic Submission of Medical (OMB) for each collection of administering postmarketing Device Registration and Listing.’’ information they conduct or sponsor. surveillance programs for devices, (6) Received comments will be placed in ‘‘Collection of information’’ is defined identification of devices marketed in the docket and, except for those in 44 U.S.C. 3502(3) and 5 CFR violation of the law, (7) identification submitted as ‘‘Confidential 1320.3(c) and includes Agency requests and control of devices imported into the Submissions,’’ publicly viewable at or requirements that members of the country from foreign establishments, (8) http://www.regulations.gov or at the public submit reports, keep records, or and scheduling and planning Division of Dockets Management provide information to a third party. inspections of registered establishments between 9 a.m. and 4 p.m., Monday Section 3506(c)(2)(A) of the PRA (44 under section 704 of the FD&C Act (21 through Friday. U.S.C. 3506(c)(2)(A)) requires Federal U.S.C. 374) • Confidential Submissions—To Agencies to provide a 60-day notice in Respondents to this information submit a comment with confidential the Federal Register concerning each collection are owners or operators of information that you do not wish to be proposed collection of information, establishments that engage in the made publicly available, submit your including each proposed extension of an manufacturing, preparation, comments only as a written/paper existing collection of information, propagation, compounding, or submission. You should submit two before submitting the collection to OMB processing of a device or devices, who copies total. One copy will include the for approval. To comply with this must register their establishments and information you claim to be confidential requirement, FDA is publishing notice submit listing information for each of with a heading or cover note that states of the proposed collection of their devices in commercial ‘‘THIS DOCUMENT CONTAINS information set forth in this document. distribution. Notwithstanding certain CONFIDENTIAL INFORMATION.’’ The With respect to the following exceptions, foreign device Agency will review this copy, including collection of information, FDA invites establishments that manufacture, the claimed confidential information, in comments on these topics: (1) Whether prepare, propagate, compound, or its consideration of comments. The the proposed collection of information process a device that is imported or second copy, which will have the is necessary for the proper performance offered for import into the United States claimed confidential information of FDA’s functions, including whether must also comply with the registration redacted/blacked out, will be available the information will have practical and listing requirements. The number of for public viewing and posted on http:// utility; (2) the accuracy of FDA’s respondents is based on data from the www.regulations.gov. Submit both estimate of the burden of the proposed FDA Unified Registration and Listing copies to the Division of Dockets collection of information, including the System. Management. If you do not wish your validity of the methodology and Burden estimates are based on recent name and contact information to be assumptions used; (3) ways to enhance experience with the existing medical made publicly available, you can the quality, utility, and clarity of the device registration and listing program, provide this information on the cover information to be collected; and (4) electronic system operating experience, sheet and not in the body of your ways to minimize the burden of the and the economic analysis for the final

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rule entitled ‘‘Implementation of Device Response Act of 2002, the Medical Drug Administration Amendments Act Registration and Listing Requirements Device User Fee and Modernization Act of 2007.’’ Enacted in the Public Health Security of 2002, and Title II of the Food and FDA estimates the burden of this and Bioterrorism Preparedness and collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Number of Average 21 CFR section FDA form No. Number of responses per Total annual burden per Total hours respondents respondent responses response

807.20(a)(5) 2—Submittal of manufacturer information by ini- tial importers ...... 3673 8,594 1 8,594 1.75 15,040 807.20(a)(5) 3—Submittal of manufacturer information by ini- tial importers ...... 3673 8,594 3 25,782 0.1 2,578 807.21(a) 3—Creation of electronic system account ...... 3673 3,559 1 3,559 0.5 1,780 807.21(b) 2—Annual request for waiver from electronic reg- istration & listing ...... 14 1 14 1 14 807.21(b) 3—Initial request for waiver from electronic registra- tion & listing ...... 4 1 4 1 4 807.22(a) 3—Initial registration & listing ...... 3673 3,539 1 3,539 0.5 1,770 807.22(b)(1) 3—Annual registration ...... 3673 20,355 1 20,355 0.75 15,266 807.22(b)(2) 3—Other updates of registration ...... 3673 4,176 1 4,176 0.5 2,088 807.22(b)(3) 3—Annual update of listing information ...... 3673 19,875 1 19,875 1 19,875 807.26(e) 3—Labeling & advertisement submitted at FDA re- quest ...... 71 1 71 1 71 807.34(a) 2—Initial registration & listing when electronic filing waiver granted ...... 14 1 14 1 14 807.34(a) 3—Annual registration & listing when electronic fil- ing waiver granted ...... 4 1 4 1 4 807.40(b)(2) 3—Annual update of US agent information ...... 3673 1,615 1 1,615 0.5 808 807.40(b)(3) 3—US agent responses to FDA requests for in- formation ...... 3673 1,535 1 1,535 0.25 384 807.41(a) 3—Identification of initial importers by foreign estab- lishments ...... 3673 10,329 1 10,329 0.5 5,165 807.41(b) 3—Identification of other parties that facilitate import by foreign establishments ...... 3673 10,329 1 10,329 0.5 5,165

Total on-time burden ...... 15,068 Total recurring burden ...... 54,958 1 There are no capital costs or operating and maintenance costs associated with this collection of information. 2 One-time burden. 3 Recurring burden.

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

Number of Average 21 CFR section Number of records per Total annual burden per Total hours recordkeepers recordkeeper records recordkeeping

807.25(d) 2—List of Officers, Directors & Partners ...... 23,806 1 23,806 0.25 5,952 807.26 2—Labeling & Advertisements Available for Review ...... 11,746 4 46,984 0.5 23,492

Total ...... 29,444 1 There are no capital costs or operating and maintenance costs associated with this collection of information. 2 Recurring burden.

Dated: October 21, 2015. DEPARTMENT OF HEALTH AND Compounding Using Bulk Drug Leslie Kux, HUMAN SERVICES Substances Under Section 503A of the Associate Commissioner for Policy. Federal Food, Drug, and Cosmetic Act.’’ Food and Drug Administration [FR Doc. 2015–27199 Filed 10–26–15; 8:45 am] The draft guidance describes FDA’s interim regulatory policy regarding the BILLING CODE 4164–01–P [Docket No. FDA–2015–D–3517] use of bulk drug substances by licensed pharmacists in State-licensed Interim Policy on Compounding Using pharmacies or Federal facilities and by Bulk Drug Substances Under Section licensed physicians to compound 503A of the Federal Food, Drug, and human drug products while FDA Cosmetic Act; Draft Guidance; develops the list of bulk drug substances Availability that can be used in compounding under AGENCY: Food and Drug Administration, the Federal Food, Drug, and Cosmetic HHS. Act (FD&C Act). When final, the guidance will reflect the Agency’s ACTION: Notice of availability. current thinking on the issues addressed SUMMARY: The Food and Drug by the guidance. Administration (FDA or Agency) is DATES: Although you can comment on announcing the availability of a draft any guidance at any time (see 21 CFR guidance entitled ‘‘Interim Policy on 10.115(g)(5)), to ensure that the Agency

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