83 FR 34596 - Agency Information Collection Activities; Proposed Collection; Comment Request; 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 140 (July 20, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 140 (July 20, 2018)
| Page Range | 34596-34598 | |
| FR Document | 2018-15512 |
[Federal Register Volume 83, Number 140 (Friday, July 20, 2018)] [Notices] [Pages 34596-34598] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-15512] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2008-N-0500] Agency Information Collection Activities; Proposed Collection; Comment Request; Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products 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 information collection provisions of FDA's requirements on content and format of labeling for human prescription drug and biological products. DATES: Submit either electronic or written comments on the collection of information by September 18, 2018. ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before September 18, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of September 18, 2018. 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. 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-2008-N-0500 for ``Agency Information Collection Activities; Proposed Collection; Comment Request; Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products.'' Received comments, those filed in a timely manner (see ADDRESSES), 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 [[Page 34597]] 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.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 Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726, [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. 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 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. FDA estimates the burden of this collection of information as follows: [[Page 34598]] 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: July 16, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-15512 Filed 7-19-18; 8:45 am] BILLING CODE 4164-01-P
![34596 Federal Register / Vol. 83, No. 140 / Friday, July 20, 2018 / Notices
except in accordance with 21 CFR 10.20 DEPARTMENT OF HEALTH AND third party may not wish to be posted,
and other applicable disclosure law. For HUMAN SERVICES such as medical information, your or
more information about FDA’s posting anyone else’s Social Security number, or
of comments to public dockets, see 80 Food and Drug Administration confidential business information, such
FR 56469, September 18, 2015, or access [Docket No. FDA–2008–N–0500] as a manufacturing process. Please note
the information at: https://www.gpo.gov/ that if you include your name, contact
fdsys/pkg/FR-2015-09-18/pdf/2015- Agency Information Collection information, or other information that
23389.pdf. Activities; Proposed Collection; identifies you in the body of your
Comment Request; Requirements on comments, that information will be
Docket: For access to the docket to posted on https://www.regulations.gov.
Content and Format of Labeling for
read background documents or the Human Prescription Drug and • If you want to submit a comment
electronic and written/paper comments Biological Products with confidential information that you
received, go to https:// do not wish to be made available to the
www.regulations.gov and insert the AGENCY: Food and Drug Administration, public, submit the comment as a
docket number, found in brackets in the HHS. written/paper submission and in the
heading of this document, into the ACTION: Notice. manner detailed (see ‘‘Written/Paper
‘‘Search’’ box and follow the prompts Submissions’’ and ‘‘Instructions’’).
SUMMARY: The Food and Drug
and/or go to the Dockets Management Administration (FDA or Agency) is Written/Paper Submissions
Staff, 5630 Fishers Lane, Rm. 1061, announcing an opportunity for public
Rockville, MD 20852. Submit written/paper submissions as
comment on the proposed collection of follows:
FOR FURTHER INFORMATION CONTACT: certain information by the Agency. • Mail/Hand delivery/Courier (for
Virginia Recta, Center for Veterinary Under the Paperwork Reduction Act of written/paper submissions): Dockets
Medicine (HFV–160), Food and Drug 1995 (PRA), Federal Agencies are Management Staff (HFA–305), Food and
Administration, 7500 Standish Pl., required to publish notice in the Drug Administration, 5630 Fishers
Rockville, MD 20855, 240–402–0840, Federal Register concerning each Lane, Rm. 1061, Rockville, MD 20852.
virginia.recta@fda.hhs.gov.
proposed collection of information, • For written/paper comments
including each proposed extension of an submitted to the Dockets Management
SUPPLEMENTARY INFORMATION: In the existing collection of information, and Staff, FDA will post your comment, as
Federal Register of May 21, 2018, FDA to allow 60 days for public comment in well as any attachments, except for
published a notice announcing the response to the notice. This notice information submitted, marked and
availability of draft revised GFI #197 solicits comments on the information identified, as confidential, if submitted
entitled ‘‘Documenting Electronic Data collection provisions of FDA’s as detailed in ‘‘Instructions.’’
Files and Statistical Analysis Programs’’ requirements on content and format of Instructions: All submissions received
with a 60-day comment period. We labeling for human prescription drug must include the Docket No. FDA–
requested comments about informing and biological products. 2008–N–0500 for ‘‘Agency Information
sponsors of recommendations for DATES: Submit either electronic or Collection Activities; Proposed
documenting electronic data files and written comments on the collection of Collection; Comment Request;
statistical analyses submitted to CVM to information by September 18, 2018. Requirements on Content and Format of
support new animal drug applications. ADDRESSES: You may submit comments Labeling for Human Prescription Drug
as follows. Please note that late, and Biological Products.’’ Received
These recommendations are intended to
untimely filed comments will not be comments, those filed in a timely
reduce the number of revisions that may
considered. Electronic comments must manner (see ADDRESSES), will be placed
be required for CVM to effectively
be submitted on or before September 18, in the docket and, except for those
review data submissions and to simplify submitted as ‘‘Confidential
submission preparation by providing a 2018. The https://www.regulations.gov
electronic filing system will accept Submissions,’’ publicly viewable at
recommended documentation https://www.regulations.gov or at the
comments until midnight Eastern Time
framework. Dockets Management Staff between 9
at the end of September 18, 2018.
The Agency has received a request for Comments received by mail/hand a.m. and 4 p.m., Monday through
a 90-day extension of the comment delivery/courier (for written/paper Friday.
period. The request conveyed concern submissions) will be considered timely • Confidential Submissions—To
that the current 60-day comment period if they are postmarked or the delivery submit a comment with confidential
does not allow sufficient time to service acceptance receipt is on or information that you do not wish to be
develop a comprehensive response. before that date. made publicly available, submit your
comments only as a written/paper
FDA has considered the request and Electronic Submissions submission. You should submit two
is extending the comment period for the Submit electronic comments in the copies total. One copy will include the
notice of availability for 90 days, until following way: information you claim to be confidential
October 18, 2018. The Agency believes • Federal eRulemaking Portal: with a heading or cover note that states
that a 90-day extension allows adequate https://www.regulations.gov. Follow the ‘‘THIS DOCUMENT CONTAINS
time for interested persons to submit instructions for submitting comments. CONFIDENTIAL INFORMATION.’’ The
comments. Comments submitted electronically, Agency will review this copy, including
daltland on DSKBBV9HB2PROD with NOTICES
Dated: July 16, 2018. including attachments, to https:// the claimed confidential information, in
Leslie Kux,
www.regulations.gov will be posted to its consideration of comments. The
the docket unchanged. Because your second copy, which will have the
Associate Commissioner for Policy.
comment will be made public, you are claimed confidential information
[FR Doc. 2018–15568 Filed 7–19–18; 8:45 am] solely responsible for ensuring that your redacted/blacked out, will be available
BILLING CODE 4164–01–P comment does not include any for public viewing and posted on
confidential information that you or a https://www.regulations.gov. Submit
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![34598 Federal Register / Vol. 83, No. 140 / Friday, July 20, 2018 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
21 CFR part and activity responses per burden Total hours
respondents responses
respondent 2 per 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 submissions) will be considered timely manner (see ADDRESSES), will be placed
information collection reflects an if they are postmarked or the delivery in the docket and, except for those
overall increase of 602,503 hours and a service acceptance receipt is on or submitted as ‘‘Confidential
corresponding increase of 345 records. before that date. Submissions,’’ publicly viewable at
We attribute this adjustment to an https://www.regulations.gov or at the
Electronic Submissions
increase in the number of submissions Dockets Management Staff between 9
we received over the last few years. Submit electronic comments in the a.m. and 4 p.m., Monday through
following way: Friday.
Dated: July 16, 2018.
• Federal eRulemaking Portal: • Confidential Submissions—To
Leslie Kux, https://www.regulations.gov. Follow the
Associate Commissioner for Policy.
submit a comment with confidential
instructions for submitting comments. information that you do not wish to be
[FR Doc. 2018–15512 Filed 7–19–18; 8:45 am] Comments submitted electronically, made publicly available, submit your
BILLING CODE 4164–01–P including attachments, to https:// comments only as a written/paper
www.regulations.gov will be posted to submission. You should submit two
the docket unchanged. Because your copies total. One copy will include the
DEPARTMENT OF HEALTH AND comment will be made public, you are
HUMAN SERVICES information you claim to be confidential
solely responsible for ensuring that your with a heading or cover note that states
comment does not include any ‘‘THIS DOCUMENT CONTAINS
Food and Drug Administration confidential information that you or a CONFIDENTIAL INFORMATION.’’ The
[Docket No. FDA–2018–D–1098] third party may not wish to be posted, Agency will review this copy, including
such as medical information, your or the claimed confidential information, in
Metered Dose Inhaler and Dry Powder anyone else’s Social Security number, or
Inhaler Drug Products—Quality its consideration of comments. The
confidential business information, such second copy, which will have the
Considerations; Draft Guidance for as a manufacturing process. Please note
Industry; Reopening of the Comment claimed confidential information
that if you include your name, contact redacted/blacked out, will be available
Period information, or other information that for public viewing and posted on
AGENCY: Food and Drug Administration, identifies you in the body of your https://www.regulations.gov. Submit
HHS. comments, that information will be
both copies to the Dockets Management
posted on https://www.regulations.gov.
Notice; reopening of the
ACTION: Staff. If you do not wish your name and
• If you want to submit a comment
comment period. with confidential information that you contact information to be made publicly
do not wish to be made available to the available, you can provide this
SUMMARY: The Food and Drug information on the cover sheet and not
Administration (FDA, Agency, or we) is public, submit the comment as a
written/paper submission and in the in the body of your comments and you
reopening the comment period for the must identify this information as
‘‘Metered Dose Inhaler and Dry Powder manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’). ‘‘confidential.’’ Any information marked
Inhaler Drug Products—Quality as ‘‘confidential’’ will not be disclosed
Considerations; Draft Guidance for Written/Paper Submissions except in accordance with 21 CFR 10.20
Industry,’’ published in the Federal and other applicable disclosure law. For
Submit written/paper submissions as
Register of April 19, 2018. FDA is more information about FDA’s posting
follows:
reopening the comment period to allow • Mail/Hand delivery/Courier (for of comments to public dockets, see 80
interested persons additional time to written/paper submissions): Dockets FR 56469, September 18, 2015, or access
submit comments. Management Staff (HFA–305), Food and the information at: https://www.gpo.gov/
DATES: FDA is reopening the comment Drug Administration, 5630 Fishers fdsys/pkg/FR-2015-09-18/pdf/2015-
period on the notice published April 19, Lane, Rm. 1061, Rockville, MD 20852. 23389.pdf.
2018 (83 FR 17420). Submit either • For written/paper comments Docket: For access to the docket to
electronic or written comments by submitted to the Dockets Management read background documents or the
September 18, 2018. Staff, FDA will post your comment, as electronic and written/paper comments
ADDRESSES: You may submit comments well as any attachments, except for received, go to https://
as follows. Please note that late, information submitted, marked and www.regulations.gov and insert the
untimely filed comments will not be identified, as confidential, if submitted docket number, found in brackets in the
considered. Electronic comments must as detailed in ‘‘Instructions.’’ heading of this document, into the
daltland on DSKBBV9HB2PROD with NOTICES
be submitted on or before September 18, Instructions: All submissions received ‘‘Search’’ box and follow the prompts
2018. The https://www.regulations.gov must include the Docket No. FDA– and/or go to the Dockets Management
electronic filing system will accept 2018–D–1098 for ‘‘Metered Dose Inhaler Staff, 5630 Fishers Lane, Rm. 1061,
comments until midnight Eastern Time and Dry Powder Inhaler Drug Rockville, MD 20852.
at the end of September 18, 2018. Products—Quality Considerations; Draft Submit written requests for single
Comments received by mail/hand Guidance for Industry.’’ Received copies of the draft guidance to the
delivery/courier (for written/paper comments, those filed in a timely Division of Drug Information, Center for
VerDate Sep<11>2014 18:06 Jul 19, 2018 Jkt 244001 PO 00000 Frm 00063 Fmt 4703 Sfmt 4703 E:\FR\FM\20JYN1.SGM 20JYN1](https://thefederalregister.org/doc/83_FR_34736/page/3.svg)
Document Created: 2018-07-20 01:19:00
Document Modified: 2018-07-20 01:19:00
| 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 September 18, 2018. | |
| Contact | Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726, [email protected] | |
| FR Citation | 83 FR 34596 |
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