83 FR 6036 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Content and Format of Labeling for Human Prescription Drugs and Biological Products; Requirements for Pregnancy and Lactation Labeling
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 29 (February 12, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 29 (February 12, 2018)
| Page Range | 6036-6038 | |
| FR Document | 2018-02765 |
[Federal Register Volume 83, Number 29 (Monday, February 12, 2018)] [Notices] [Pages 6036-6038] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-02765] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-5624] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Content and Format of Labeling for Human Prescription Drugs and Biological Products; Requirements for Pregnancy and Lactation Labeling AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- 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 March 14, 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 0910-0624. Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733, [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. Content and Format of Labeling for Human Prescription Drugs and Biological Products; Requirements for Pregnancy and Lactation Labeling OMB Control Number 0910-0624--Extension This information collection supports Agency regulations regarding the content and format requirements for pregnancy and lactation labeling. In the Federal Register of December 4, 2014 (79 FR 72064), FDA published a final rule entitled ``Content and Format of Labeling for Human Prescription Drug and Biological Products; Requirements for Pregnancy and Lactation Labeling.'' The final rule amended FDA regulations concerning the content and format of the ``Pregnancy,'' ``Labor and delivery,'' and ``Nursing mothers'' subsections of the ``Use in Specific Populations'' section of the labeling for human prescription drugs. The regulations now require, among other things, a summary of the risks of using a drug during pregnancy and lactation and a discussion of the data supporting that summary. The labeling must also include relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy and lactation. The final rule eliminated the pregnancy categories A, B, C, D, and X. In addition, FDA eliminated the ``Labor and delivery'' subsection because the ``Pregnancy'' subsection includes information on labor and delivery. The final rule also required that the labeling include relevant information about pregnancy testing, contraception, and infertility for health care providers prescribing for females and males of reproductive potential. In addition, the final rule provided for a 10-year implementation schedule for compliance with the relevant regulations. As the implementation schedule is realized, FDA plans to discontinue this separate information collection and incorporate the provisions into existing collections as appropriate. The content and format requirements apply to:Applications submitted on or after June 30, 2015 (Sec. Sec. 314.50 (21 CFR 314.50), 314.70(b) (21 CFR 314.70(b)), 601.2 (21 CFR 601.2), and 601.12(f)(1)) (21 CFR 601.12(f)(1)); amendments to applications pending on June 30, 2015 (Sec. Sec. 314.60 (21 CFR 314.60), 601.2, and 601.12(f)(1)); supplements to applications approved from June 30, 2001, to June 30, 2015 (Sec. Sec. 314.70(b) and 601.12(f)(1)); and annual reports for applications approved before June 30, 2001, that contain a pregnancy category, to report removal of the pregnancy category letter in their labeling (Sec. Sec. 314.70(d) and 601.12(f)(3)). Under Sec. 201.57(c)(9)(i) and (ii) (21 CFR 201.57(c)(9)(i) and (ii)), holders of approved applications must provide new labeling content in a new format--that is, to rewrite the pregnancy and lactation portions of each drug's labeling. Section 201.57(c)(9)(iii) requires that labeling must include the [[Page 6037]] new subsection 8.3, ``Females and males of reproductive potential.'' Application holders are required to submit prior approval supplements to their approved applications before distribution of the new labeling, as required in Sec. 314.70(b) or Sec. 601.12(f)(1) (21 CFR 601.12(f)(1)). Under 21 CFR 201.80(f)(6)(i), holders of approved applications are required to remove the pregnancy category designation (e.g., ``Pregnancy Category C'') from the ``Pregnancy'' subsection of the ``Precautions'' section of the labeling. These application holders must report the labeling change in their annual reports, as required in Sec. 314.70(d) or Sec. 601.12(f)(3). In the Federal Register of October 4, 2017 (82 FR 46248), we published a 60-day notice requesting public comment on the proposed extension of this collection of information. Two comments were received in response to the notice, however both comments discussed specific requirements found in FDA regulations rather than the four information collection topics solicited in our notice under the PRA. We have therefore not made adjustments to our burden estimate for the information collection, which is as follows: Table 1--Estimated Annual Third-Party Disclosure Burden \1\ ---------------------------------------------------------------------------------------------------------------- Number of Type of submission (21 CFR Number of disclosures Total annual Average burden Total hours section) respondents per respondent disclosures per disclosure ---------------------------------------------------------------------------------------------------------------- New NDAs/ANDAs/BLAs/efficacy 390 ~10 4,000 (Submitted 40 160,000 supplements submitted on or during 10-year after June 30, 2015, period after including amendments to June 30, 2015). applications pending as of June 30, 2015 (Sec. Sec. 314.50, 314.60, 314.70(b), 601.2, 601.12(f)(1)). ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. Table 2--Estimated Annual Reporting Burden \1\ ---------------------------------------------------------------------------------------------------------------- Number of Type of submission (21 CFR Number of responses per Total annual Average burden Total hours section) respondents respondent responses per response ---------------------------------------------------------------------------------------------------------------- Supplements to applications 390 26 10,150 120 1,218,000 approved June 30, 2001 to (Submitted 3rd, June 30, 2015 (Sec. Sec. 4th, and 5th 314.70(b), 601.12(f)(1)). years after June 30, 2015). Annual report submission of 320 ~17 5,500 (Submitted 40 220,000 revised labeling for 3rd year after applications that contain a June 30, 2015). pregnancy category, approved before June 30, 2001 (Sec. Sec. 314.70(d), 601.12(f)(3)). -------------------------------- ------------------------------- Total..................... .............. .............. ................ .............. 1,438,000 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. As indicated in tables 1 and 2, we estimate the burden associated with the information collection to be 1,598,000 hours. We estimate 4,000 applications containing the subject labeling will be submitted by approximately 390 applicants and repackagers and relabelers to FDA over the 10-year period beginning June 30, 2015. This figure (4,000 applications) includes labeling for approximately 800 applications submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 505(b)) or section 351 of the Public Health Service Act (42 U.S.C. 262), 1,200 applications submitted under section 505(j) of the FD&C Act, and 2,000 revised drug product labeling from repackagers and relabelers for approximately 2,000. This estimate also includes labeling amendments submitted to FDA for applications pending as of the effective date of the final rule. We estimate it will take applicants 40 hours to prepare and submit the subject labeling. This estimate applies only to the requirements found in the previous paragraphs and does not indicate the total hours required to prepare and submit complete labeling for these applications. The information collection burden to prepare and submit labeling in accordance with Sec. Sec. 201.56 (21 CFR 201.56), 201.57, and 201.80 is approved by OMB under control numbers 0910-0572 and 0910-0001. In addition, during the third, fourth, and fifth years after the effective date of the final rule, the Agency estimates that it will receive approximately 10,150 supplements to applications that were either approved from June 30, 2001, to the effective date or were pending as of the effective date. This estimate includes supplements for approximately 1,080 new drug application (NDAs), and biologics license applications (BLAs), and efficacy supplements; 1,320 abbreviated new drug application (ANDA) supplements; and 7,750 drug product labeling supplements from repackagers and relabelers. FDA estimates 390 application holders, repackagers, and relabelers will submit these supplements, and that it will take 120 hours to prepare and submit each supplement. Finally, we estimate that application holders will submit 5,500 annual reports to FDA during the third year after the effective date for applications that contain a pregnancy category, approved before June 30, 2001. This estimate includes approximately 1,340 NDAs and BLAs and approximately 4,160 ANDAs containing labeling changes as a result of the final rule. FDA estimates that approximately 320 application holders will submit these annual reports, and that it will take approximately 40 hours for each submission. The burden for this information collection has not increased since the last collection. [[Page 6038]] Dated: February 6, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-02765 Filed 2-9-18; 8:45 am] BILLING CODE 4164-01-P
![6036 Federal Register / Vol. 83, No. 29 / Monday, February 12, 2018 / Notices
was initially submitted on August 30, DEPARTMENT OF HEALTH AND rule entitled ‘‘Content and Format of
2012. HUMAN SERVICES Labeling for Human Prescription Drug
3. The date the application was and Biological Products; Requirements
Food and Drug Administration for Pregnancy and Lactation Labeling.’’
approved: August 13, 2014. FDA has
[Docket No. FDA–2017–N–5624] The final rule amended FDA regulations
verified the applicant’s claim that NDA
concerning the content and format of
204569 was approved on August 13,
Agency Information Collection the ‘‘Pregnancy,’’ ‘‘Labor and delivery,’’
2014. and ‘‘Nursing mothers’’ subsections of
Activities; Submission for Office of
This determination of the regulatory Management and Budget Review; the ‘‘Use in Specific Populations’’
review period establishes the maximum Comment Request; Content and section of the labeling for human
potential length of a patent extension. Format of Labeling for Human prescription drugs. The regulations now
However, the USPTO applies several Prescription Drugs and Biological require, among other things, a summary
statutory limitations in its calculations Products; Requirements for Pregnancy of the risks of using a drug during
of the actual period for patent extension. and Lactation Labeling pregnancy and lactation and a
In its application for patent extension, discussion of the data supporting that
this applicant seeks zero days of patent AGENCY: Food and Drug Administration, summary. The labeling must also
term extension. HHS. include relevant information to help
ACTION: Notice. health care providers make prescribing
III. Petitions decisions and counsel women about the
SUMMARY: The Food and Drug use of drugs during pregnancy and
Anyone with knowledge that any of Administration (FDA) is announcing lactation. The final rule eliminated the
the dates as published are incorrect may that a proposed collection of pregnancy categories A, B, C, D, and X.
submit either electronic or written information has been submitted to the In addition, FDA eliminated the ‘‘Labor
comments and, under 21 CFR 60.24, ask Office of Management and Budget and delivery’’ subsection because the
for a redetermination (see DATES). (OMB) for review and clearance under ‘‘Pregnancy’’ subsection includes
Furthermore, as specified in § 60.30 (21 the Paperwork Reduction Act of 1995. information on labor and delivery. The
CFR 60.30), any interested person may DATES: Fax written comments on the final rule also required that the labeling
petition FDA for a determination collection of information by March 14, include relevant information about
regarding whether the applicant for 2018. pregnancy testing, contraception, and
extension acted with due diligence ADDRESSES: To ensure that comments on infertility for health care providers
during the regulatory review period. To the information collection are received, prescribing for females and males of
meet its burden, the petition must OMB recommends that written reproductive potential. In addition, the
comply with all the requirements of comments be faxed to the Office of final rule provided for a 10-year
§ 60.30, including but not limited to: Information and Regulatory Affairs, implementation schedule for
Must be timely (see DATES), must be OMB, Attn: FDA Desk Officer, Fax: 202– compliance with the relevant
filed in accordance with § 10.20, must 395–7285, or emailed to oira_ regulations. As the implementation
contain sufficient facts to merit an FDA submission@omb.eop.gov. All schedule is realized, FDA plans to
comments should be identified with the discontinue this separate information
investigation, and must certify that a
OMB control number 0910–0624. Also collection and incorporate the
true and complete copy of the petition
include the FDA docket number found provisions into existing collections as
has been served upon the patent
in brackets in the heading of this appropriate.
applicant. (See H. Rept. 857, part 1, 98th The content and format requirements
Cong., 2d sess., pp. 41–42, 1984.) document.
apply to:
Petitions should be in the format FOR FURTHER INFORMATION CONTACT: • Applications submitted on or after
specified in 21 CFR 10.30. Domini Bean, Office of Operations, June 30, 2015 (§§ 314.50 (21 CFR
Submit petitions electronically to Food and Drug Administration, Three 314.50), 314.70(b) (21 CFR 314.70(b)),
https://www.regulations.gov at Docket White Flint North, 10A–12M, 11601 601.2 (21 CFR 601.2), and 601.12(f)(1))
No. FDA–2013–S–0610. Submit written Landsdown St., North Bethesda, MD (21 CFR 601.12(f)(1));
petitions (two copies are required) to the 20852, 301–796–5733, PRAStaff@ • amendments to applications
fda.hhs.gov. pending on June 30, 2015 (§§ 314.60 (21
Dockets Management Staff (HFA–305),
SUPPLEMENTARY INFORMATION: In CFR 314.60), 601.2, and 601.12(f)(1));
Food and Drug Administration, 5630
compliance with 44 U.S.C. 3507, FDA • supplements to applications
Fishers Lane, Rm. 1061, Rockville, MD approved from June 30, 2001, to June
20852. has submitted the following proposed
collection of information to OMB for 30, 2015 (§§ 314.70(b) and 601.12(f)(1));
Dated: February 7, 2018.
review and clearance. and
Leslie Kux, • annual reports for applications
Associate Commissioner for Policy.
Content and Format of Labeling for approved before June 30, 2001, that
Human Prescription Drugs and contain a pregnancy category, to report
[FR Doc. 2018–02763 Filed 2–9–18; 8:45 am]
Biological Products; Requirements for removal of the pregnancy category letter
BILLING CODE 4164–01–P Pregnancy and Lactation Labeling in their labeling (§§ 314.70(d) and
601.12(f)(3)).
OMB Control Number 0910–0624— Under § 201.57(c)(9)(i) and (ii) (21
daltland on DSKBBV9HB2PROD with NOTICES
Extension CFR 201.57(c)(9)(i) and (ii)), holders of
This information collection supports approved applications must provide
Agency regulations regarding the new labeling content in a new format—
content and format requirements for that is, to rewrite the pregnancy and
pregnancy and lactation labeling. In the lactation portions of each drug’s
Federal Register of December 4, 2014 labeling. Section 201.57(c)(9)(iii)
(79 FR 72064), FDA published a final requires that labeling must include the
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![6038 Federal Register / Vol. 83, No. 29 / Monday, February 12, 2018 / Notices
Dated: February 6, 2018. instructions for submitting comments. its consideration of comments. The
Leslie Kux, Comments submitted electronically, second copy, which will have the
Associate Commissioner for Policy. including attachments, to https:// claimed confidential information
[FR Doc. 2018–02765 Filed 2–9–18; 8:45 am] www.regulations.gov will be posted to redacted/blacked out, will be available
BILLING CODE 4164–01–P the docket unchanged. Because your for public viewing and posted on
comment will be made public, you are https://www.regulations.gov. Submit
solely responsible for ensuring that your both copies to the Dockets Management
DEPARTMENT OF HEALTH AND comment does not include any Staff. If you do not wish your name and
HUMAN SERVICES confidential information that you or a contact information to be made publicly
third party may not wish to be posted, available, you can provide this
Food and Drug Administration such as medical information, your or information on the cover sheet and not
[Docket No. FDA–2015–E–3877] anyone else’s Social Security number, or in the body of your comments and you
confidential business information, such must identify this information as
Determination of Regulatory Review as a manufacturing process. Please note ‘‘confidential.’’ Any information marked
Period for Purposes of Patent that if you include your name, contact as ‘‘confidential’’ will not be disclosed
Extension; AKYNZEO information, or other information that except in accordance with § 10.20 (21
identifies you in the body of your CFR 10.20) and other applicable
AGENCY: Food and Drug Administration, comments, that information will be disclosure law. For more information
HHS. posted on https://www.regulations.gov. about FDA’s posting of comments to
ACTION: Notice. • If you want to submit a comment public dockets, see 80 FR 56469,
with confidential information that you September 18, 2015, or access the
SUMMARY: The Food and Drug do not wish to be made available to the
Administration (FDA or the Agency) has information at: http://www.gpo.gov/
public, submit the comment as a fdsys/pkg/FR-2015-09-18/pdf/2015-
determined the regulatory review period
written/paper submission and in the 23389.pdf.
for AKYNZEO and is publishing this
manner detailed (see ‘‘Written/Paper Docket: For access to the docket to
notice of that determination as required
Submissions’’ and ‘‘Instructions’’). read background documents or the
by law. FDA has made the
determination because of the Written/Paper Submissions electronic and written/paper comments
submission of an application to the received, go to https://
Submit written/paper submissions as
Director of the U.S. Patent and www.regulations.gov and insert the
follows:
Trademark Office (USPTO), Department docket number, found in brackets in the
• Mail/Hand delivery/Courier (for
of Commerce, for the extension of a heading of this document, into the
written/paper submissions): Dockets
patent which claims that human drug ‘‘Search’’ box and follow the prompts
Management Staff (HFA–305), Food and
product. and/or go to the Dockets Management
Drug Administration, 5630 Fishers
Staff, 5630 Fishers Lane, Rm. 1061,
DATES: Anyone with knowledge that any Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments Rockville, MD 20852.
of the dates as published (see the
SUPPLEMENTARY INFORMATION section) are submitted to the Dockets Management FOR FURTHER INFORMATION CONTACT:
incorrect may submit either electronic Staff, FDA will post your comment, as Beverly Friedman, Office of Regulatory
or written comments and ask for a well as any attachments, except for Policy, Food and Drug Administration,
redetermination by April 13, 2018. information submitted, marked and 10903 New Hampshire Ave., Bldg. 51,
Furthermore, any interested person may identified, as confidential, if submitted Rm. 6250, Silver Spring, MD 20993,
petition FDA for a determination as detailed in ‘‘Instructions.’’ 301–796–3600.
regarding whether the applicant for Instructions: All submissions received SUPPLEMENTARY INFORMATION:
extension acted with due diligence must include the Docket No. FDA–
2015–E–3877 for ‘‘Determination of I. Background
during the regulatory review period by
August 13, 2018. See ‘‘Petitions’’ in the Regulatory Review Period for Purposes The Drug Price Competition and
SUPPLEMENTARY INFORMATION section for of Patent Extension; AKYNZEO.’’ Patent Term Restoration Act of 1984
more information. Received comments, those filed in a (Pub. L. 98–417) and the Generic
ADDRESSES: You may submit comments timely manner (see ADDRESSES), will be Animal Drug and Patent Term
as follows. Please note that late, placed in the docket and, except for Restoration Act (Pub. L. 100–670)
untimely filed comments will not be those submitted as ‘‘Confidential generally provide that a patent may be
considered. Electronic comments must Submissions,’’ publicly viewable at extended for a period of up to 5 years
be submitted on or before April 13, https://www.regulations.gov or at the so long as the patented item (human
2018. The https://www.regulations.gov Dockets Management Staff between 9 drug product, animal drug product,
electronic filing system will accept a.m. and 4 p.m., Monday through medical device, food additive, or color
comments until midnight Eastern Time Friday. additive) was subject to regulatory
at the end of April 13, 2018. Comments • Confidential Submissions—To review by FDA before the item was
received by mail/hand delivery/courier submit a comment with confidential marketed. Under these acts, a product’s
(for written/paper submissions) will be information that you do not wish to be regulatory review period forms the basis
considered timely if they are made publicly available, submit your for determining the amount of extension
postmarked or the delivery service comments only as a written/paper an applicant may receive.
acceptance receipt is on or before that submission. You should submit two A regulatory review period consists of
daltland on DSKBBV9HB2PROD with NOTICES
date. copies total. One copy will include the two periods of time: A testing phase and
information you claim to be confidential an approval phase. For human drug
Electronic Submissions with a heading or cover note that states products, the testing phase begins when
Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS the exemption to permit the clinical
following way: CONFIDENTIAL INFORMATION.’’ The investigations of the drug becomes
• Federal eRulemaking Portal: Agency will review this copy, including effective and runs until the approval
https://www.regulations.gov. Follow the the claimed confidential information, in phase begins. The approval phase starts
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Document Created: 2018-11-01 08:41:58
Document Modified: 2018-11-01 08:41:58
| 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 | Fax written comments on the collection of information by March 14, 2018. | |
| Contact | Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733, [email protected] | |
| FR Citation | 83 FR 6036 |
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