82 FR 24351 - Agency Information Collection Activities: Proposed Collection; Comment Request; Applications for Food and Drug Administration Approval To Market a New Drug
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 101 (May 26, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 101 (May 26, 2017)
| Page Range | 24351-24356 | |
| FR Document | 2017-10818 |
[Federal Register Volume 82, Number 101 (Friday, May 26, 2017)] [Notices] [Pages 24351-24356] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-10818] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0523] Agency Information Collection Activities: Proposed Collection; Comment Request; Applications for Food and Drug Administration Approval To Market a New Drug AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the requirements governing applications for FDA approval to market a new drug. DATES: Submit either electronic or written comments on the collection of information by June 26, 2017. Late, untimely filed comments will not be considered. Electronic comments must be submitted on or before July 25, 2017. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time [[Page 24352]] at the end of July 25, 2017. Comments received by mail/hand delivery/ courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. ADDRESSES: You may submit comments 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): 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-2013-N-0523 for ``Agency Information Collection Activities; Proposed Collection; Comment Request; Applications for FDA Approval to Market a New Drug.'' Received comments, those filed in a timely manner (see DATES), 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: https://www.thefederalregister.org/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 Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733, [email protected]. SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. ``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document. With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. Application for FDA Approval To Market a New Drug OMB Control Number 0910-0001--Extension Under section 505(a) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355(a)), a new drug may not be commercially marketed in the United States, imported, or exported from the United States, unless an approval of an application filed with FDA under section 505(b) or (j) of the FD&C Act is effective with respect to such drug. The Agency has codified regulations regarding applications for FDA approval to market a new drug under 21 CFR part 314. This collection of information supports the regulatory requirements found in those regulations. The collection of information is necessary for FDA to make a scientific and technical determination whether the product is safe and effective for use, and is summarized as follows: Section 314.50(a) requires that an application form (Form FDA 356h) be submitted that includes information about the applicant, the submission, and a checklist of enclosures. Section 314.50(b) requires that an index be submitted with the archival [[Page 24353]] copy of the application and that it reference certain sections of the application. Section 314.50(c) requires that a summary of the application be submitted that presents a good general synopsis of all the technical sections and other information in the application. Section 314.50(d) requires that the NDA contain the following technical sections about the new drug: (1) Chemistry, manufacturing, and controls; (2) nonclinical pharmacology and toxicology; (3) human pharmacokinetics and bioavailability; (4) microbiology; (5) clinical data; (6) statistical; and (7) pediatric use sections. Section 314.50(e) requires the applicant to submit samples of the drug if requested by FDA. In addition, the archival copy of the application must include copies of the label and all labeling for the drug. Section 314.50(f) requires that case report forms and tabulations be submitted with the archival copy. Section 314.50(h) requires that patent information, as described under Sec. 314.53, be submitted with the application. However, burden hours for Sec. 314.50(h) are approved under OMB control numbers 0910- 0513, Patent Certification Forms 3542 and 3542a and 0910-0786, Abbreviated New Drug Applications and 505(b)(2) Applications and are therefore not included among the estimates found in table 1. Section 314.50(i) requires that patent certification information be submitted in section 505(b)(2) applications for patents claiming the drug substance, drug product, or method of use. Sections 314.50(i)(1)(i)(C) and 314.54(i) and (j) require that patent certification information be submitted for each patent listed in the ``Approved Drug Products with Therapeutic Equivalence Evaluations'' (the Orange Book) for a drug product approved in an NDA that is pharmaceutically equivalent to the proposed drug product in the original 505(b)(2) application and was submitted and was approved before the original 505(b)(2) application was submitted. Burden for these provisions is included under OMB control number 0910-0786. Section 314.50(j) requires that applicants who request a period of marketing exclusivity submit certain information with the application. Section 314.50(k) requires that the application contain a financial certification or disclosure statement or both. Section 314.50(l) requires that an archival, review, and field copy of the application be submitted, including the content of labeling and all labeling and labels. Section 314.52 requires that any notice of certification of invalidity, unenforceability, or non-infringement of a patent to each patent owner and the NDA holder be sent by a section 505(b)(2) applicant that relies on a listed drug. A 505(b)(2) applicant is required to amend its application at the time notice is provided to include a statement certifying that the required notice has been provided. A 505(b)(2) applicant also is required to amend its application to document receipt of the required notice. Burden hours for these provisions are included in OMB control number 0910-0786. Section 314.53 sets forth the patent information requirements for applicants who submit applications or amendments to the application filed under section 505(b)(2) of the FD&C Act or supplements to the approved 505(b)(2) application. Burden hours for these collections are approved in OMB control number 0910-0786. Section 314.54 sets forth the content requirements for applications filed under section 505(b)(2) of the FD&C Act. The burden estimate for 505(b)(2) applications is included in table 1 under the estimates for Sec. 314.50(a) through (g) and (i) through (l). Section 314.55 sets forth the assessment requirements for each application. The burden estimate for 505(b)(2) applications is included in table 1 under the estimates for Sec. [thinsp]314.50(a) through (g) and (i) through (l). Section 314.60 sets forth reporting requirements and patent certification requirements for sponsors who amend an unapproved 505(b)(2) application. Burden hours for the Sec. 314.60(f) collections are approved under OMB control number 0910-0786. Section 314.65 states that the sponsor must notify FDA when withdrawing an unapproved application. Sections 314.70 and 314.71 require that supplements be submitted to FDA for certain changes to an approved application. Section 314.72 requires sponsors to report to FDA any transfer of ownership of an application. Section 314.80(c)(1) and (2) sets forth requirements for expedited adverse drug experience postmarketing reports and followup reports, as well as for periodic adverse drug experience postmarketing reports (Form FDA 3500A). Section 314.80(i) establishes recordkeeping requirements for reports of postmarketing adverse drug experiences. The burden hours for Sec. 314.80(i) are approved under OMB control numbers 0910-0230, Adverse Drug Experience Reporting and 0910-0291, MedWatch: FDA's Medical Reporting Program and therefore burden estimates are not included in table 1. Section 314.81(b)(1) requires that NDA and ANDA field alert reports be submitted to FDA (Forms FDA 3331 and 3331a). Section 314.81(b)(2) requires that annual reports be submitted to FDA (Form FDA 2252). Section 314.81(b)(3)(i) requires that drug advertisements and promotional labeling be submitted to FDA (Form FDA 2253). Section 314.81(b)(3)(iii) sets forth reporting requirements for sponsors who withdraw an approved drug product from sale. The burden hours for Sec. [thinsp]314.81(b)(3)(iii) are approved under OMB control number 0910-0045, Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution and therefore are not included in table 1. Section 314.90 sets forth requirements for sponsors who request waivers from FDA for compliance with Sec. Sec. 314.50 through 314.81. The information collection burden estimate for NDA waiver requests is included in table 1 under the estimates for each section that is in part 314, subpart B. Section 314.93 sets forth requirements for submitting a suitability petition to request a change from a listed drug in accordance with Sec. Sec. 10.20 and 10.30. The burden hours for Sec. [thinsp]314.93 are approved under OMB control number 0910-0191, Administrative Practices and Procedures; Formal Evidentiary Public Hearing and are not included in table 1. Section 314.94(a) through (d) require that an ANDA contain the following information: (1) Application form; (2) table of contents; (3) basis for ANDA submission; (4) conditions of use; (5) active ingredients; (6) route of administration, dosage form, and strength; (7) bioequivalence; (8) labeling; (9) chemistry, manufacturing, and controls; (10) samples; and (11) patent certification. Section 314.95 requires that any notice of certification of invalidity or non-infringement of a patent to each patent owner and the NDA holder be sent by ANDA applicants. Section 314.96 sets forth requirements for amendments to an unapproved ANDA. Section 314.97 sets forth requirements for submitting supplements to an approved ANDA for certain changes to the application. Approval of burden hours for information collections for [[Page 24354]] Sec. Sec. 314.95, through 314.97 are covered under OMB control number 0910-0786. Section 314.98(a) sets forth postmarketing adverse drug experience reporting and recordkeeping requirements for ANDAs. The burden hours for Sec. 314.98(a) are approved under OMB control numbers 0910-0230 and 0910-0291 and are not included in table 1. Section 314.98(b) requires other postmarketing reports for ANDAs: (1) Field alert reports (Form FDA 3331a); (2) annual reports (Form FDA 2252); and (3) advertisements and promotional labeling (Form FDA 2253). (The information collection burden estimate for field alert reports is included in table 1 under Sec. [thinsp]314.81(b)(1); the estimate for annual reports is included under Sec. 314.81(b)(2); the estimate for advertisements and promotional labeling is included under Sec. 314.81(b)(3)(i).) Section 314.99(a) requires that sponsors comply with certain reporting requirements for withdrawing an unapproved ANDA and for a change in ownership of an ANDA. Section 314.99(b) sets forth requirements for sponsors who request waivers from FDA for compliance with Sec. Sec. 314.92 through 314.99. (The information collection burden estimate for ANDA waiver requests is included in table 1 under the estimates for each section that is in part 314, subpart C.) Section 314.101(a) states that if FDA refuses to file an application, the applicant may request an informal conference with FDA and request that the application be filed over protest. Section 314.107(c) requires notice to FDA by the first applicant to submit a substantially complete ANDA containing a certification that a relevant patent is invalid, unenforceable, or will not be infringed of the date of first commercial marketing. The burden estimate for Sec. 314.107(c) is included in table 1 under the estimates for Sec. 314.50(a) through (g) and (i) through (l). Section 314.107(e) requires that an applicant submit a copy of the entry of the order or judgment to FDA within 10 working days of a final judgment. The burden estimate for Sec. 314.107(e) applications is included in table 1 under the estimates for Sec. 314.50(a) through (g) and (i) through (l) and is approved under OMB control number 0910-0786. Section 314.107(f) requires that ANDA or section 505(b)(2) applicants notify FDA immediately of the filing of any legal action filed within 45 days of receipt of the notice of certification. A patent owner must also notify FDA of the filing of any legal action for patent infringement. If the patent owner or approved application holder who is an exclusive patent licensee waives its opportunity to file a legal action for patent infringement within the 45-day period, the patent owner or approved application holder may submit to FDA a waiver in the specified format. The burden estimate for Sec. 314.107(f) is included in table 1 under the estimates for Sec. 314.50 (a) through (g) and (i) through (l) and is approved under OMB control number 0910- 0786. Section 314.110(b)(3) states that, after receipt of an FDA complete response letter, an applicant must either: (1) Resubmit the application addressing all the deficiencies identified in the complete response letter; (2) withdraw the application or; (3) request an opportunity for a hearing on the question of whether there are grounds for denying approval of the application. The burden hours for Sec. 314.110(b)(3) are included under parts 10 through 16 (21 CFR parts 10 through 16, OMB control number 0910-0191) hearing regulations, in accordance with Sec. 314.201, and are not included in table 1. Section 314.122(a) requires that an ANDA or a suitability petition that relies on a listed drug that has been voluntarily withdrawn from sale must be accompanied by a petition seeking a determination whether the drug was withdrawn for safety or effectiveness reasons. The burden hours for Sec. 314.122(a) are approved under OMB control number 0910- 0191 and therefore are not included in table 1. Section 314.122(d) sets forth requirements for relisting petitions for unlisted discontinued products. The burden hours for Sec. 314.122(d) are approved under OMB control number 0910-0191 and therefore are not included in table 1. Sections 314.125 and 314.127 state that FDA may refuse to approve an NDA or an ANDA and will provide the applicant written notice of an opportunity for a hearing under Sec. 314.200 along with the reason for refusal to approve the application, including lack of a patent certification or statement with respect to each listed patent for an approved drug product that is pharmaceutically equivalent to the drug product for which the original 505(b)(2) application is submitted and was approved before the original 505(b)(2) was submitted. The burden hours for Sec. Sec. 314.125 and 314.127 (refuse to approve an ANDA) are included under parts 10 through 16 hearing regulations (in accordance with Sec. 314.201) and approved under OMB control number 0910-0191, and therefore are not included in table 1. Section 314.126(c) sets forth requirements for a petition to waive criteria for adequate and well-controlled studies. The burden hours for Sec. 314.126(c) are approved under OMB control number 0910-0191 and therefore are not included in table 1. Sections 314.150(a) and (b) and 314.151(a) and (b) set forth requirements for the withdrawal of approval of an NDA or ANDA and the applicant's opportunity for a hearing and submission of comments. The burden hours for Sec. 314.151(a) and (b) are included under parts 10 through 16 hearing regulations, in accordance with Sec. 314.201, and approved under OMB control number 0910-0191 and therefore are not included in table 1. Section 314.151(c) sets forth the requirements for withdrawal of approval of an ANDA and the applicant's opportunity to submit written objections and participate in a limited oral hearing. The burden hours for Sec. 314.151(c) are included under parts 10 through 16 hearing regulations, in accordance with Sec. 314.201, approved under OMB control number 0910-0191, and therefore are not included in table 1. Section 314.153(b) sets forth the requirements for suspension of an ANDA when the listed drug is voluntarily withdrawn for safety and effectiveness reasons, and the applicant's opportunity to present comments and participate in a limited oral hearing. The burden hours for Sec. 314.152(b) are included under parts 10 through 16 hearing regulations, in accordance with Sec. 314.201, approved under OMB control number 0910-0191, and therefore are not included in table 1. Section 314.161(b) and (e) sets forth the requirements for submitting a petition to determine whether a listed drug was voluntarily withdrawn from sale for safety or effectiveness reasons. The burden hours for Sec. 314.161(b) and (e) are approved under OMB control number 0910-0191 and therefore are not included in table 1. Section 314.200(c), (d), and (e) requires that applicants or others subject to a notice of opportunity for a hearing who wish to participate in a hearing file a written notice of participation and request for a hearing as well as the studies, data, and so forth, relied on. Other interested persons may also submit comments on the notice. This section also sets forth the content and format requirements for the applicants' submission in response to notice of opportunity for hearing. The burden hours for Sec. 314.200(c), (d), and (e) are included under parts 10 through 16 hearing regulations, in accordance with [[Page 24355]] Sec. 314.201, are approved under OMB control number 0910-0191, and therefore are not included in table 1. Section 314.200(f) states that participants in a hearing may make a motion to the presiding officer for the inclusion of certain issues in the hearing. The burden hours for Sec. 314.200(f) are included under parts 10 through 16 hearing regulations, in accordance with Sec. 314.201, are approved under OMB control number 0910-0191, and therefore are not included in table 1. Section 314.200(g) states that a person who responds to a proposed order from FDA denying a request for a hearing provide sufficient data, information, and analysis to demonstrate that there is a genuine and substantial issue of fact which justifies a hearing. The burden hours for Sec. 314.200(g) are included under parts 10 through 16 hearing regulations, in accordance with Sec. 314.201, are approved under OMB control number 0910-0191, and therefore are not included in table 1. Section 314.420 states that an applicant may submit to FDA a drug master file in support of an application, in accordance with certain content and format requirements. Section 314.430 states that data and information in an application are disclosable under certain conditions, unless the applicant shows that extraordinary circumstances exist. The burden hours for Sec. 314.430 are included under parts 10 through 16 hearing regulations, in accordance with Sec. 314.201, are approved under OMB control number 0910-0191, and therefore are not included in table 1. Section 314.530(c) and (e) states that if FDA withdraws approval of a drug approved under the accelerated approval procedures, the applicant has the opportunity to request a hearing and submit data and information. The burden hours for Sec. 314.530(c) and (e) are included under parts 10 through 16 hearing regulations, in accordance with Sec. 314.201, are approved under OMB control number 0910-0191, and therefore are not included in table 1. Section 314.530(f) requires that an applicant first submit a petition for stay of action before requesting an order from a court for a stay of action pending review. The burden hours for Sec. 314.530(f) are approved under OMB control number 0910-0191, and therefore are not included in table 1. Section 314.550 requires an applicant with a new drug product being considered for accelerated approval to submit copies of all promotional materials to the FDA during the preapproval and post-approval periods. Section 314.610(b)(1) requires that applicants include a plan or approach to postmarketing study commitments in applications for approval of new drugs when human efficacy studies are not ethical or feasible, and provide status reports of postmarketing study commitments. The burden estimate for Sec. 314.610(b)(1) is included in table 1 under the estimates for Sec. Sec. 314.50 (a) through (f), (k), and (l) and 314.81(b)(2)). Section 314.610(b)(3) requires that applicants propose labeling to be provided to patient recipients in applications for approval of new drugs when human efficacy studies are not ethical or feasible. The burden estimate for Sec. 314.610(b)(3) is included in table 1 under the estimates for Sec. 314.50(e). Section 314.630 requires that applicants provide postmarketing safety reporting for applications for approval of new drugs when human efficacy studies are not ethical or feasible. The burden hours for Sec. 314.630 are approved under OMB control numbers 0910-0230 and 0910-0291 and therefore not included in table 1. Section 314.640 requires that applicants provide promotional materials for applications for approval of new drugs when human efficacy studies are not ethical or feasible. The burden estimate for Sec. 314.640 is included in table 1 under the estimates for Sec. 314.81(b)(3)(i)). Accordingly, we estimate the burden for this 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 ---------------------------------------------------------------------------------------------------------------- 314.50(a)-(g), (i)-(l) [356h]-- 378 1.33 503 1,921 966,263 Content and format of a 505(b)(1) or 505(b)(2) application.................... 314.52--Non-infringement of 7 3 21 16 336 patents (NDAs)................. 314.95--Non-infringement of 209 3 627 16 10,032 patents (ANDAs)................ 314.60--Amendments.............. 564 9.96 5,618 80 449,440 314.65--Withdrawal of unapproved 27 71.63 1934 2 3,868 applications................... 314.70 and 314.71--Supplements 838 7.04 5,897 150 884,550 and submissions................ 314.72--Change of ownership..... 142 2.04 289 2 578 314.81--Other postmarketing 342 19.98 6,834 8 54,672 reports and 314.81(b)(1) [3331 and 3331a] field alert reports. 314.81(b)(2) [2252]--Annual 913 5.07 4632 40 185,280 reports........................ 314.81(b)(3)(i) [2253]-- 529 81.66 43,198 2 86,396 Promotional labeling........... 314.94(a) and (d)--ANDA content. 180.5 3.75 676.5 480 324,720 314.96(a)(1)--Amendments to 514 26.66 13,647 80 1,091,760 unapproved ANDAs............... 314.97--Supplements to ANDAs.... 343 17.57 6027 80 482,160 314.99(a)--Responsibilities of 265 7.04 1867 2 3,734 ANDA Applicants................ 314.101(a)--ANDA filing......... 1 1 1 .5 .5 (30 minutes) 314.420--Drug Master Files...... 500 2.06 1,028 61 62,708 314.550--Promotional material 29 7.76 225 120 27,000 and subpart H applications..... ------------------------------------------------------------------------------- Total....................... .............. .............. .............. .............. 4,633,497.5 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. [[Page 24356]] Dated: May 22, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-10818 Filed 5-25-17; 8:45 am] BILLING CODE 4164-01-P
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information they conduct or sponsor. 2. Type of Information Collection ability of states to permit agents and
The term ‘‘collection of information’’ is Request: Revision of a currently brokers to assist qualified individuals,
defined in 44 U.S.C. 3502(3) and 5 CFR approved information collection qualified employers, or qualified
1320.3(c) and includes agency requests request; Title of Information Collection: employees enrolling in Qualified Health
or requirements that members of the Information Collection for Machine Plans in the Federally Facilitated
public submit reports, keep records, or Readable Data for Provider Network and Exchange (§ 155.220) and ICRs related to
provide information to a third party. Prescription Formulary Content for FFM non-exchange entities (§ 155.260). Form
Section 3506(c)(2)(A) of the PRA QHPs; Use: Under 45 CFR Number: CMS–10650 (OMB Control
requires federal agencies to publish a 156.122(d)(1)(2) and 156.230(c) and in Number 0939—NEW); Frequency:
60-day notice in the Federal Register the final rule, Patient Protection and Annually; Affected Public: Private
concerning each proposed collection of Affordable Care Act; HHS Notice of Sector, State, Business, and Not-for
information, including each proposed Benefit and Payment Parameters for Profits; Number of Respondents:
extension or reinstatement of an existing 2018 (CMS–9934–F), standards for 107,207; Number of Responses: 107,207;
collection of information, before qualified health plan (QHP) issuers are Total Annual Hours: 512,141. (For
submitting the collection to OMB for established for the submission of questions regarding this collection
approval. To comply with this provider and formulary data in a contact Joshua Annas at (301–492–
requirement, CMS is publishing this machine- readable format to the 4407).
notice. Department of Health and Human
Dated: May 23, 2017.
Services (HHS) and for posting on issuer
Information Collection William N. Parham, III,
Web sites. These standards provide
1. Type of Information Collection greater transparency for consumers, Director, Paperwork Reduction Staff, Office
Request: Revision of a currently including by allowing software of Strategic Operations and Regulatory
approved collection; Title of Affairs.
developers to access formulary and
Information Collection: Disclosure of [FR Doc. 2017–10944 Filed 5–25–17; 8:45 am]
provider data to create innovative and
State Rating Requirements; Use: The informative tools. Form Number: CMS– BILLING CODE 4120–01–P
final rule ‘‘Patient Protection and 10558 (OMB Control Number 0938–
Affordable Care Act; Health Insurance 1284); Frequency: Annually; Affected
Market Rules; Rate Review’’ implements Public: Private Sector, State, Business, DEPARTMENT OF HEALTH AND
sections 2701, 2702, and 2703 of the and Not-for Profits; Number of HUMAN SERVICES
Public Health Service Act (PHS Act), as Respondents: 397; Number of
added and amended by the Affordable Food and Drug Administration
Responses: 397; Total Hours: 208. (For
Care Act, and sections 1302(e) and questions regarding this collection [Docket No. FDA–2013–N–0523]
1312(c) of the Affordable Care Act. The contact Joshua Annas at (301) 492-
rule directs that states submit to CMS 4407.) Agency Information Collection
certain information about state rating 3. Type of Information Collection Activities: Proposed Collection;
and risk pooling requirements for their Request: New collection of information Comment Request; Applications for
individual, small group, and large group request; Title of Information Collection: Food and Drug Administration
markets, as applicable. Specifically, State Permissions for Enrollment in Approval To Market a New Drug
states will inform CMS of age rating Qualified Health Plans in the Federally
ratios that are narrower than 3:1 for AGENCY: Food and Drug Administration,
Facilitated Exchange & Non-Exchange
adults; tobacco use rating ratios that are HHS.
Entities; Use: The Patient Protection and
narrower than 1.5:1; a state-established Affordable Care Act, Public Law 111– ACTION: Notice.
uniform age curve; geographic rating 148, enacted on March 23, 2010, and the
areas; whether premiums in the small SUMMARY: The Food and Drug
Health Care and Education
and large group market are required to Administration (FDA or Agency) is
Reconciliation Act, Public Law 111–
be based on average enrollee amounts announcing an opportunity for public
152, enacted on March 30, 2010
(also known as composite premiums); comment on the proposed collection of
(collectively, ‘‘Affordable Care Act’’),
and, in states that do not permit any certain information by the Agency.
expand access to health insurance for
rating variation based on age or tobacco individuals and employees of small Under the Paperwork Reduction Act of
use, uniform family tier structures and businesses through the establishment of 1995 (PRA), Federal Agencies are
corresponding multipliers. In addition, new Affordable Insurance Exchanges required to publish notice in the
states that elect to merge their (Exchanges), also called Marketplaces, Federal Register concerning each
individual and small group market risk including the Small Business Health proposed collection of information,
pools into a combined pool will notify Options Program (SHOP). The including each proposed extension of an
CMS of such election. This information Exchanges, which became operational existing collection of information, and
will allow CMS to determine whether on January 1, 2014, enhance to allow 60 days for public comment in
state-specific rules apply or Federal competition in the health insurance response to the notice. This notice
default rules apply. It will also support market, expand access to affordable solicits comments on the requirements
the accuracy of the federal risk health insurance for millions of governing applications for FDA
adjustment methodology. Form Number: Americans, and provide consumers with approval to market a new drug.
CMS–10454 (OMB Control Number a place to easily compare and shop for DATES: Submit either electronic or
0938–1258); Frequency: On Occasion; health insurance coverage. written comments on the collection of
Affected Public: State, Local, or Tribal This Information Collection Request information by June 26, 2017. Late,
Governments, Private Sector; Number of (ICR) serves as the formal request for a untimely filed comments will not be
Respondents: 47; Number of Responses: new data collection clearance associated considered. Electronic comments must
47; Total Annual Hours: 2,239. (For with the HHS Notice of Benefit and be submitted on or before July 25, 2017.
policy questions regarding this Payment Parameters for 2018 Final Rule The https://www.regulations.gov
collection, contact Russell Tipps at 301– (2018 Payment Notice). This ICR electronic filing system will accept
492–4371.) includes data collections related to the comments until midnight Eastern Time
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![Federal Register / Vol. 82, No. 101 / Friday, May 26, 2017 / Notices 24355
§ 314.201, are approved under OMB extraordinary circumstances exist. The applications for approval of new drugs
control number 0910–0191, and burden hours for § 314.430 are included when human efficacy studies are not
therefore are not included in table 1. under parts 10 through 16 hearing ethical or feasible, and provide status
Section 314.200(f) states that regulations, in accordance with reports of postmarketing study
participants in a hearing may make a § 314.201, are approved under OMB commitments. The burden estimate for
motion to the presiding officer for the control number 0910–0191, and § 314.610(b)(1) is included in table 1
inclusion of certain issues in the therefore are not included in table 1. under the estimates for §§ 314.50 (a)
hearing. The burden hours for Section 314.530(c) and (e) states that through (f), (k), and (l) and 314.81(b)(2)).
§ 314.200(f) are included under parts 10 if FDA withdraws approval of a drug Section 314.610(b)(3) requires that
through 16 hearing regulations, in approved under the accelerated applicants propose labeling to be
accordance with § 314.201, are approval procedures, the applicant has provided to patient recipients in
approved under OMB control number the opportunity to request a hearing and applications for approval of new drugs
0910–0191, and therefore are not submit data and information. The when human efficacy studies are not
included in table 1. burden hours for § 314.530(c) and (e) are ethical or feasible. The burden estimate
Section 314.200(g) states that a person included under parts 10 through 16 for § 314.610(b)(3) is included in table 1
who responds to a proposed order from hearing regulations, in accordance with under the estimates for § 314.50(e).
FDA denying a request for a hearing § 314.201, are approved under OMB Section 314.630 requires that
provide sufficient data, information, and control number 0910–0191, and applicants provide postmarketing safety
analysis to demonstrate that there is a therefore are not included in table 1. reporting for applications for approval
genuine and substantial issue of fact Section 314.530(f) requires that an of new drugs when human efficacy
which justifies a hearing. The burden applicant first submit a petition for stay studies are not ethical or feasible. The
hours for § 314.200(g) are included of action before requesting an order burden hours for § 314.630 are approved
under parts 10 through 16 hearing from a court for a stay of action pending under OMB control numbers 0910–0230
regulations, in accordance with review. The burden hours for and 0910–0291 and therefore not
§ 314.201, are approved under OMB § 314.530(f) are approved under OMB included in table 1.
control number 0910–0191, and control number 0910–0191, and Section 314.640 requires that
therefore are not included in table 1. therefore are not included in table 1. applicants provide promotional
Section 314.420 states that an Section 314.550 requires an applicant materials for applications for approval
applicant may submit to FDA a drug with a new drug product being of new drugs when human efficacy
master file in support of an application, considered for accelerated approval to studies are not ethical or feasible. The
in accordance with certain content and submit copies of all promotional burden estimate for § 314.640 is
format requirements. materials to the FDA during the included in table 1 under the estimates
Section 314.430 states that data and preapproval and post-approval periods. for § 314.81(b)(3)(i)).
information in an application are Section 314.610(b)(1) requires that Accordingly, we estimate the burden
disclosable under certain conditions, applicants include a plan or approach to for this collection of information as
unless the applicant shows that postmarketing study commitments in follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Total Average
21 CFR Section/ Number of responses per annual burden per Total hours
[FDA Form No.] respondents respondent responses response
314.50(a)–(g), (i)–(l) [356h]—Content and format of a
505(b)(1) or 505(b)(2) application .................................... 378 1.33 503 1,921 966,263
314.52—Non-infringement of patents (NDAs) ..................... 7 3 21 16 336
314.95—Non-infringement of patents (ANDAs) .................. 209 3 627 16 10,032
314.60—Amendments ......................................................... 564 9.96 5,618 80 449,440
314.65—Withdrawal of unapproved applications ................ 27 71.63 1934 2 3,868
314.70 and 314.71—Supplements and submissions .......... 838 7.04 5,897 150 884,550
314.72—Change of ownership ............................................ 142 2.04 289 2 578
314.81—Other postmarketing reports and 314.81(b)(1)
[3331 and 3331a] field alert reports ................................. 342 19.98 6,834 8 54,672
314.81(b)(2) [2252]—Annual reports ................................... 913 5.07 4632 40 185,280
314.81(b)(3)(i) [2253]—Promotional labeling ....................... 529 81.66 43,198 2 86,396
314.94(a) and (d)—ANDA content ...................................... 180.5 3.75 676.5 480 324,720
314.96(a)(1)—Amendments to unapproved ANDAs ........... 514 26.66 13,647 80 1,091,760
314.97—Supplements to ANDAs ........................................ 343 17.57 6027 80 482,160
314.99(a)—Responsibilities of ANDA Applicants ................ 265 7.04 1867 2 3,734
314.101(a)—ANDA filing ...................................................... 1 1 1 .5 .5
(30 minutes)
314.420—Drug Master Files ................................................ 500 2.06 1,028 61 62,708
314.550—Promotional material and subpart H applications 29 7.76 225 120 27,000
Total .............................................................................. ........................ ........................ ........................ ........................ 4,633,497.5
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
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![24356 Federal Register / Vol. 82, No. 101 / Friday, May 26, 2017 / Notices
Dated: May 22, 2017. FOR FURTHER INFORMATION CONTACT: on medical devices in clinical use. This
Anna K. Abram, Amber Sanford, Office of Operations, system is called the Medical Product
Deputy Commissioner for Policy, Planning, Food and Drug Administration, Three Safety Network (MedSun).
Legislation, and Analysis. White Flint North, 10A63, 11601 FDA is seeking OMB clearance to
[FR Doc. 2017–10818 Filed 5–25–17; 8:45 am] Landsdown St., North Bethesda, MD continue to use electronic data
BILLING CODE 4164–01–P 20852, 301–796–8867, PRAStaff@ collection to obtain the information on
fda.hhs.gov. Form FDA 3500A (approved under
SUPPLEMENTARY INFORMATION: In OMB control number 0910–0291)
DEPARTMENT OF HEALTH AND related to medical devices and tissue
compliance with 44 U.S.C. 3507, FDA
HUMAN SERVICES products from the user facilities
has submitted the following proposed
Food and Drug Administration collection of information to OMB for participating in MedSun, to obtain a
review and clearance. demographic profile of the facilities,
[Docket No. FDA–2017–N–0084] and for additional questions, which will
Adverse Event Program for Medical permit FDA to better understand the
Agency Information Collection Devices (Medical Product Safety cause of reported adverse events.
Activities; Submission for Office of Network (MedSun)); OMB Control Participation in the program is
Management and Budget Review; Number 0910–0471—Extension voluntary and includes approximately
Comment Request; Adverse Event 250 facilities.
Program for Medical Devices (Medical Under section 519 of the Federal
Product Safety Network) Food, Drug, and Cosmetic Act (the In addition to collecting data on the
FD&C Act) (21 U.S.C. 360i) authorizes electronic adverse event report form,
AGENCY: Food and Drug Administration, FDA to require: (1) Manufacturers to MedSun collects additional information
HHS. report medical device-related deaths, from participating sites about reported
ACTION: Notice. serious injuries, and malfunctions and problems emerging from the MedSun
(2) user facilities to report device-related hospitals. This data collection is also
SUMMARY: The Food and Drug deaths directly to manufacturers and voluntary and is collected on the same
Administration (FDA) is announcing FDA and serious injuries to the Web site as the report information.
that a proposed collection of manufacturer. Section 213 of the Food
information has been submitted to the The burden estimate is based on the
and Drug Administration Modernization number of facilities participating in
Office of Management and Budget Act of 1997 (Pub. L. 105–115) amended
(OMB) for review and clearance under MedSun (250). FDA estimates an
section 519(b) of the FD&C Act relating average of 15 reports per site annually.
the Paperwork Reduction Act of 1995. to mandatory reporting by user facilities
DATES: Fax written comments on the This estimate is based on MedSun
of deaths, serious injuries, and serious working to promote reporting in general
collection of information by June 26, illnesses associated with the use of
2017. from the sites, as well as promoting
medical devices. This amendment reporting from specific parts of the
ADDRESSES: To ensure that comments on legislated the replacement of universal hospitals, such as the pediatric
the information collection are received, user facility reporting by a system that intensive care units, the
OMB recommends that written is limited to a ‘‘. . . subset of user electrophysiology laboratories, and the
comments be faxed to the Office of facilities that constitutes a hospital laboratories.
Information and Regulatory Affairs, representative profile of user reports’’
OMB, Attn: FDA Desk Officer, Fax: 202– for device-related deaths and serious In the Federal Register of January 19,
395–7285, or emailed to oira_ injuries. This amendment is reflected in 2017 (82 FR 6566), FDA published a 60-
submission@omb.eop.gov. All section 519(b)(5)(A) of the FD&C Act. day notice requesting public comment
comments should be identified with the This legislation provides FDA with the on the proposed collection of
OMB control number 0910–0471. Also opportunity to design and implement a information. No comments were
include the FDA docket number found national surveillance network, received.
in brackets in the heading of this composed of well-trained clinical FDA estimates the burden of this
document. facilities, to provide high-quality data collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
Activity responses per burden per Total hours
respondents responses
respondent response
Adverse event reporting ............................................................ 250 15 3,750 .75 (45 2,813
minutes).
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: May 22, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–10844 Filed 5–25–17; 8:45 am]
BILLING CODE 4164–01–P
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Document Created: 2017-05-26 02:24:40
Document Modified: 2017-05-26 02:24:40
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Submit either electronic or written comments on the collection of information by June 26, 2017. Late, untimely filed comments will not be considered. Electronic comments must be submitted on or before July 25, 2017. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of July 25, 2017. Comments received by mail/hand delivery/ courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. | |
| Contact | Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733, [email protected] | |
| FR Citation | 82 FR 24351 |
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