83_FR_59001 83 FR 58776 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; General Licensing Provisions; Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products

83 FR 58776 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; General Licensing Provisions; Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 225 (November 21, 2018)

Page Range58776-58777
FR Document2018-25352

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

Federal Register, Volume 83 Issue 225 (Wednesday, November 21, 2018) 
[Federal Register Volume 83, Number 225 (Wednesday, November 21, 2018)]
[Notices]
[Pages 58776-58777]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-25352]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0500]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; General Licensing 
Provisions; Requirements on Content and Format of Labeling for Human 
Prescription Drug and Biological Products

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by 
December 21, 2018.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
Fax: 202-395-7285, or emailed to [email protected]. All 
comments should be identified with the OMB control number 0910-0572. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of 
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794, 
[email protected].

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Requirements on Content and Format of Labeling for Human Prescription 
Drug and Biological Products

OMB Control Number 0910-0572--Extension

    FDA's regulations governing the content and format of labeling for 
human prescription drug and biological products were revised in the 
Federal Register of January 24, 2006 (71 FR 3922) (the 2006 labeling 
rule) to require that the labeling of new and recently approved 
products contain highlights of prescribing information, a table of 
contents for prescribing information, reordering of certain sections, 
minor content changes, and minimum graphical requirements. These 
revisions were intended to make it easier for health care practitioners 
to access, read, and use information in prescription drug labeling; to 
enhance the safe and effective use of prescription drug products; and 
to reduce the number of adverse reactions resulting from medication 
errors because of misunderstood or incorrectly applied drug 
information.
    Currently, Sec.  201.56 (21 CFR 201.56) requires that prescription 
drug labeling contain certain information in the format specified in 
either Sec.  201.57 (21 CFR 201.57) or Sec.  201.80 (21 CFR 201.80), 
depending on when the drug was approved for marketing. Section 
201.56(a) sets forth general labeling requirements applicable to all 
prescription drugs. Section 201.56(b) specifies the categories of new 
and more recently approved prescription drugs subject to the revised 
content and format requirements in Sec. Sec.  201.56(d) and 201.57. 
Section 201.56(c) sets forth the schedule for implementing these 
revised content and format requirements. Section 201.56(e) specifies 
the sections and subsections, required and optional, for the labeling 
of older prescription drugs not subject to the revised format and 
content requirements.
    Section 201.57(a) requires that prescription drug labeling for new 
and more recently approved prescription drug products include a 
``Highlights of Prescribing Information'' section. The ``Highlights'' 
section provides a concise extract of the most important information 
required under Sec.  201.57(c) (the Full Prescribing Information 
(FPI)), as well as certain additional information important to 
prescribers. Section 201.57(b) requires a table of contents to

[[Page 58777]]

prescribing information entitled ``Full Prescribing Information: 
Contents,'' consisting of a list of each heading and subheading along 
with its identifying number to facilitate health care practitioners' 
use of labeling information. Section 201.57(c) specifies the contents 
of the FPI. Section 201.57(d) mandates the minimum specifications for 
the format of prescription drug labeling and establishes minimum 
requirements for key graphic elements such as bold type, bullet points, 
type size, and spacing.
    Older drugs not subject to the revised labeling content and format 
requirements in Sec.  201.57 are subject to labeling requirements at 
Sec.  201.80. Section 201.80(f)(2) requires that, within 1 year, any 
FDA-approved patient labeling be referenced in the ``Precautions'' 
section of the labeling of older products and either accompany or be 
reprinted immediately following the labeling.
Annual Burden for Prescription Drug Labeling Design, Testing, and 
Submitting to FDA for New Drug Applications (NDAs) and Biologics 
License Applications (BLAs) (Sec. Sec.  201.56 and 201.57)
    New drug product applicants must: (1) Design and create 
prescription drug labeling containing ``Highlights,'' ``Contents,'' and 
FPI; (2) test the designed labeling (e.g., to ensure that the designed 
labeling fits into carton-enclosed products); and (3) submit it to FDA 
for approval. Based on the projected data used in the January 24, 2006, 
final rule, FDA estimates that it will take applicants approximately 
2,327 hours to design, test, and submit prescription drug labeling to 
FDA as part of a NDA or a BLA under the revised regulations. Currently, 
approximately 406 applicants submit approximately 541 new applications 
(NDAs and BLAs) to FDA annually, totaling 1,258,907 hours.
    In the Federal Register of July 20, 2018 (83 FR 34596), we 
published a 60-day notice requesting public comment on the proposed 
collection of information. We received two comments. One comment 
encouraged the use of ``provider-neutral language'' in specific 
regulations. The second comment discussed the distribution of package 
inserts for prescription drugs via paper labeling. Because these 
comments do not apply to the regulations associated with the 
information collection, we have not addressed them here.
    Our estimate of the burden for the information collection is as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                         Number of
                      21 CFR part and activity                          Number of      responses per     Total annual    Average burden    Total hours
                                                                       respondents     respondent \2\     responses       per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Labeling Requirements in Sec.  Sec.   201.56 and 201.57............             406            1.332              541            2,327        1,258,907
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Estimates may not sum due to rounding.

    Our estimated burden for the information collection reflects an 
overall increase of 602,503 hours and a corresponding increase of 345 
records. We attribute this adjustment to an increase in the number of 
submissions we received over the last few years.

    Dated: November 14, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-25352 Filed 11-20-18; 8:45 am]
BILLING CODE 4164-01-P

58776 Federal Register / Vol. 83, No. 225 / Wednesday, November 21, 2018 / Notices copies total. One copy will include the that appeared in the notice requesting SUPPLEMENTARY INFORMATION: In information you claim to be confidential data and other evidence in support of compliance with 44 U.S.C. 3507, FDA with a heading or cover note that states answers. has submitted the following proposed ‘‘THIS DOCUMENT CONTAINS We have considered the requests and collection of information to OMB for CONFIDENTIAL INFORMATION.’’ We are extending the comment period for review and clearance. will review this copy, including the another 60 days, until January 28, 2019. Requirements on Content and Format of claimed confidential information, in our We believe that a 60-day extension Labeling for Human Prescription Drug consideration of comments. The second allows adequate time for interested and Biological Products copy, which will have the claimed persons to submit comments without confidential information redacted/ significantly delaying any potential OMB Control Number 0910–0572— blacked out, will be available for public further action on these important issues. Extension viewing and posted on https:// Dated: November 15, 2018. FDA’s regulations governing the www.regulations.gov. Submit both Leslie Kux, content and format of labeling for copies to the Dockets Management Staff. human prescription drug and biological Associate Commissioner for Policy. If you do not wish your name and products were revised in the Federal [FR Doc. 2018–25347 Filed 11–20–18; 8:45 am] contact information to be made publicly Register of January 24, 2006 (71 FR available, you can provide this BILLING CODE 4164–01–P 3922) (the 2006 labeling rule) to require information on the cover sheet and not that the labeling of new and recently in the body of your comments and you approved products contain highlights of DEPARTMENT OF HEALTH AND must identify this information as prescribing information, a table of HUMAN SERVICES ‘‘confidential.’’ Any information marked contents for prescribing information, as ‘‘confidential’’ will not be disclosed Food and Drug Administration reordering of certain sections, minor except in accordance with 21 CFR 10.20 content changes, and minimum and other applicable disclosure law. For [Docket No. FDA–2008–N–0500] graphical requirements. These revisions more information about FDA’s posting were intended to make it easier for of comments to public dockets, see 80 Agency Information Collection health care practitioners to access, read, FR 56469, September 18, 2015, or access Activities; Submission for Office of and use information in prescription the information at: https://www.gpo.gov/ Management and Budget Review; drug labeling; to enhance the safe and fdsys/pkg/FR-2015-09-18/pdf/2015- Comment Request; General Licensing effective use of prescription drug 23389.pdf. Provisions; Requirements on Content products; and to reduce the number of Docket: For access to the docket to and Format of Labeling for Human adverse reactions resulting from read background documents or the Prescription Drug and Biological medication errors because of electronic and written/paper comments Products misunderstood or incorrectly applied received, go to https:// drug information. AGENCY: Food and Drug Administration, www.regulations.gov and insert the Currently, § 201.56 (21 CFR 201.56) HHS. docket number, found in brackets in the requires that prescription drug labeling heading of this document, into the ACTION: Notice. contain certain information in the ‘‘Search’’ box and follow the prompts format specified in either § 201.57 (21 SUMMARY: The Food and Drug and/or go to the Dockets Management CFR 201.57) or § 201.80 (21 CFR Administration (FDA) is announcing Staff, 5630 Fishers Lane, Rm. 1061, 201.80), depending on when the drug that a proposed collection of Rockville, MD 20852. was approved for marketing. Section information has been submitted to the FOR FURTHER INFORMATION CONTACT: Office of Management and Budget 201.56(a) sets forth general labeling Mabel Lee, Center Food Safety and (OMB) for review and clearance under requirements applicable to all Applied Nutrition, Food and Drug the Paperwork Reduction Act of 1995. prescription drugs. Section 201.56(b) Administration, 5001 Campus Dr., specifies the categories of new and more DATES: Fax written comments on the College Park, MD 20740, 240–402–2371. recently approved prescription drugs collection of information by December SUPPLEMENTARY INFORMATION: In the 21, 2018. subject to the revised content and Federal Register of September 28, 2018 format requirements in §§ 201.56(d) and ADDRESSES: To ensure that comments on (83 FR 49103), FDA published a notice 201.57. Section 201.56(c) sets forth the with a 60-day comment period inviting the information collection are received, schedule for implementing these revised interested parties to provide information OMB recommends that written content and format requirements. on specific topics related to the labeling comments be faxed to the Office of Section 201.56(e) specifies the sections of plant-based products with names that Information and Regulatory Affairs, and subsections, required and optional, include the names of dairy foods such OMB, Attn: FDA Desk Officer, Fax: 202– for the labeling of older prescription as ‘‘milk,’’ ‘‘cultured milk,’’ ‘‘yogurt,’’ 395–7285, or emailed to oira_ drugs not subject to the revised format and ‘‘cheese.’’ The information will submission@omb.eop.gov. All and content requirements. inform our development of an approach comments should be identified with the Section 201.57(a) requires that to the labeling of plant-based products OMB control number 0910–0572. Also prescription drug labeling for new and that consumers may substitute for dairy include the FDA docket number found more recently approved prescription foods. We asked that comments be in brackets in the heading of this drug products include a ‘‘Highlights of submitted by November 27, 2018. document. Prescribing Information’’ section. The khammond on DSK30JT082PROD with NOTICES We have received requests for a 120- FOR FURTHER INFORMATION CONTACT: ‘‘Highlights’’ section provides a concise day extension of the comment period for JonnaLynn Capezzuto, Office of extract of the most important the notice. The requests conveyed Operations, Food and Drug information required under § 201.57(c) concern that the current 60-day Administration, Three White Flint (the Full Prescribing Information (FPI)), comment period does not allow North, 10A–12M, 11601 Landsdown St., as well as certain additional information sufficient time to develop meaningful or North Bethesda, MD 20852, 301–796– important to prescribers. Section thoughtful responses to the questions 3794, PRAStaff@fda.hhs.gov. 201.57(b) requires a table of contents to VerDate Sep<11>2014 16:08 Nov 20, 2018 Jkt 247001 PO 00000 Frm 00022 Fmt 4703 Sfmt 4703 E:\FR\FM\21NON1.SGM 21NON1

Federal Register / Vol. 83, No. 225 / Wednesday, November 21, 2018 / Notices 58777 prescribing information entitled ‘‘Full be reprinted immediately following the revised regulations. Currently, Prescribing Information: Contents,’’ labeling. approximately 406 applicants submit consisting of a list of each heading and approximately 541 new applications Annual Burden for Prescription Drug subheading along with its identifying (NDAs and BLAs) to FDA annually, Labeling Design, Testing, and number to facilitate health care totaling 1,258,907 hours. Submitting to FDA for New Drug practitioners’ use of labeling In the Federal Register of July 20, Applications (NDAs) and Biologics information. Section 201.57(c) specifies 2018 (83 FR 34596), we published a 60- License Applications (BLAs) (§§ 201.56 the contents of the FPI. Section day notice requesting public comment 201.57(d) mandates the minimum and 201.57) New drug product applicants must: on the proposed collection of specifications for the format of (1) Design and create prescription drug information. We received two prescription drug labeling and labeling containing ‘‘Highlights,’’ comments. One comment encouraged establishes minimum requirements for ‘‘Contents,’’ and FPI; (2) test the the use of ‘‘provider-neutral language’’ key graphic elements such as bold type, designed labeling (e.g., to ensure that in specific regulations. The second bullet points, type size, and spacing. Older drugs not subject to the revised the designed labeling fits into carton- comment discussed the distribution of labeling content and format enclosed products); and (3) submit it to package inserts for prescription drugs requirements in § 201.57 are subject to FDA for approval. Based on the via paper labeling. Because these labeling requirements at § 201.80. projected data used in the January 24, comments do not apply to the Section 201.80(f)(2) requires that, within 2006, final rule, FDA estimates that it regulations associated with the 1 year, any FDA-approved patient will take applicants approximately information collection, we have not labeling be referenced in the 2,327 hours to design, test, and submit addressed them here. ‘‘Precautions’’ section of the labeling of prescription drug labeling to FDA as Our estimate of the burden for the older products and either accompany or part of a NDA or a BLA under the information collection is as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of Average Number of Total annual 21 CFR part and activity responses per burden per Total hours respondents responses respondent 2 response Labeling Requirements in §§ 201.56 and 201.57 ................ 406 1.332 541 2,327 1,258,907 1 There are no capital costs or operating and maintenance costs associated with this collection of information. 2 Estimates may not sum due to rounding. Our estimated burden for the FOR FURTHER INFORMATION CONTACT: Mr. infectious disease complications of information collection reflects an James Berger, Designated Federal Officer transplantation. overall increase of 602,503 hours and a for the ACBTSA, Senior Advisor for To carry out its mission, the ACBTSA corresponding increase of 345 records. Blood and Tissue Policy, Office of the provides advice to the Secretary through We attribute this adjustment to an Assistant Secretary for Health, the Assistant Secretary for Health on a increase in the number of submissions Department of Health and Human range of policy issues to include: (1) we received over the last few years. Services, Mary E. Switzer Building, 330 Identification of public health issues Dated: November 14, 2018. C Street SW, Suite L100, Washington, through surveillance of blood and tissue Leslie Kux, DC 20024. Phone: (202) 795–7697; Fax: safety issues with national biovigilance Associate Commissioner for Policy. (202) 691–2102; Email: ACBTSA@ data tools; (2) identification of public hhs.gov. health issues that affect availability of [FR Doc. 2018–25352 Filed 11–20–18; 8:45 am] blood, blood products, and tissues; (3) BILLING CODE 4164–01–P SUPPLEMENTARY INFORMATION: ACBTSA broad public health, ethical, and legal is a non-discretionary Federal advisory issues related to the safety of blood, committee. ACBTSA is authorized blood products, and tissues; (4) the DEPARTMENT OF HEALTH AND under 42 U.S.C. 217a, Section 222 of the HUMAN SERVICES impact of various economic factors (e.g., Public Health Service (PHS) Act, as product cost and supply) on safety and Charter Renewal of the Advisory amended. The Committee is governed availability of blood, blood products, Committee on Blood and Tissue Safety by the provisions of the Federal and tissues; (5) risk communications and Availability Advisory Committee Act (FACA), Public related to blood transfusion and tissue Law 92–463, as amended (5 U.S.C. transplantation; and (6) identification of AGENCY: Office of HIV/AIDS and App), which sets forth standards for the infectious disease transmission issues Infectious Disease Policy, Office of the formation and use of advisory for blood, organs, blood stem cells and Assistant Secretary for Health, Office of committees. tissues. the Secretary, Department of Health and The ACBTSA advises, assists, On September 25, 2018, the Secretary Human Services. consults with, and makes policy approved for the ACBTSA charter to be recommendations to the Secretary, renewed. The new charter was effected khammond on DSK30JT082PROD with NOTICES ACTION: Notice. through the Assistant Secretary for and filed with the appropriate SUMMARY: The Department of Health and Health, regarding these broad Congressional committees and the Human Services is hereby giving notice responsibilities related to the safety of Library of Congress on October 9, 2018. that the charter for the Advisory blood, blood products, tissues, and Renewal of the Committee’s charter Committee on Blood and Tissue Safety organs. For solid organs and blood stem gives authorization for the Committee to and Availability (ACBTSA) has been cells, the Committee’s work is limited to continue to operate until October 9, renewed. policy issues related to donor derived 2020. VerDate Sep<11>2014 16:08 Nov 20, 2018 Jkt 247001 PO 00000 Frm 00023 Fmt 4703 Sfmt 4703 E:\FR\FM\21NON1.SGM 21NON1


Document Created: 2018-11-21 03:11:56
Document Modified: 2018-11-21 03:11:56
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesFax written comments on the collection of information by December 21, 2018.
ContactJonnaLynn Capezzuto, Office of Operations, Food and Drug Administration, Three White Flint North, 10A- 12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794, [email protected]
FR Citation83 FR 58776 
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