82 FR 32003 - Draft Standardization of Pharmaceutical Quality/Chemistry Manufacturing and Control Data Elements and Terminologies; Request for Comments
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 131 (July 11, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 131 (July 11, 2017)
| Page Range | 32003-32004 | |
| FR Document | 2017-14456 |
[Federal Register Volume 82, Number 131 (Tuesday, July 11, 2017)] [Notices] [Pages 32003-32004] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-14456] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-2166] Draft Standardization of Pharmaceutical Quality/Chemistry Manufacturing and Control Data Elements and Terminologies; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice; request for comments. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is requesting comment on the draft standardized Pharmaceutical Quality/Chemistry Manufacturing and Control (PQ/CMC) data elements and terminologies for the electronic submission of PQ/CMC data. The establishment of standardized pharmaceutical quality data elements and terminologies will provide opportunities for FDA and industry to transform PQ/CMC submission data into a readily useable electronic format. As a result, these established data elements and terminologies will improve the efficiency and quality of the drug review process. The Agency is seeking comment on the accuracy, suitability, and appropriateness of these data elements and terminologies for submission of PQ/CMC data. FDA is considering implementing PQ/CMC requirements as a Health Level 7 (HL7) Structured Product Labeling (SPL) document. The proposed data elements and terminologies can be obtained on https://www.regulations.gov in Docket No. FDA-2017-N-2166. DATES: Submit either electronic or written comments by September 11, 2017. Late, untimely filed comments [[Page 32004]] will not be considered. Electronic comments must be submitted on or before September 11, 2017. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of September 11, 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): 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-2017-N-2166 for ``Draft Standardization of Pharmaceutical Quality/ Chemistry Manufacturing and Control Data Elements and Terminologies; Request for Comments.'' 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 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 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: Norman Schmuff, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 21, Rm. 2526, Silver Spring, MD 20993-0002, 301- 796-1454; Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911; Norman Gregory, Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Pl. (HFV-143), Rockville, MD 20855, 240-402-0684; or Michael Kerrigan, Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Pl. (HFV-143), Rockville, MD 20855, 240-402-0644. Alternatively, send questions to the PQ-CMC mailbox: [email protected]. SUPPLEMENTARY INFORMATION: I. Background PQ/CMC is a term used to describe manufacturing and testing data of pharmaceutical products. PQ/CMC encompasses topics such as drug stability, quality specification, and batch analysis, which are important aspects of drug development. PQ/CMC plays an integral part in the regulatory review process and life cycle management of pharmaceutical products. The standardization of PQ/CMC data elements and terminologies will facilitate the Agency's transition to an electronic review environment. FDA intends to identify and standardize data elements and terminologies for information commonly used and submitted in support of drug product applications. The impetus for this standardization effort was the provisions from the 2012 Food and Drug Administration Safety and Innovation Act (FDASIA) (Pub. L. 112-144), which authorized the Agency to require certain submissions to be in a specified electronic format. The development of a structured format for PQ/CMC data will enable consistency in the content and format of PQ/CMC data submitted, thus providing a harmonized language for submission content, allowing reviewers to query the data, and, in general, contributing to a more efficient and effective regulatory decision-making process by creating a standardized data dictionary. After receiving comments, the Agency will consider future actions on the standardization of PQ/CMC data elements and terminologies for electronic submissions. II. Electronic Access Persons with access to the Internet may obtain the proposed data elements and terminologies at https://www.regulations.gov. Dated: July 5, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysys. [FR Doc. 2017-14456 Filed 7-10-17; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 82, No. 131 / Tuesday, July 11, 2017 / Notices 32003
Rm. 6250, Silver Spring, MD 20993, requested that FDA determine the timely (see DATES) and contain sufficient
301–796–3600. product’s regulatory review period. facts to merit an FDA investigation. (See
SUPPLEMENTARY INFORMATION: H. Rept. 857, part 1, 98th Cong., 2d
II. Determination of Regulatory Review
sess., pp. 41–42, 1984.) Petitions should
I. Background Period
be in the format specified in 21 CFR
The Drug Price Competition and FDA has determined that the 10.30.
Patent Term Restoration Act of 1984 applicable regulatory review period for Submit petitions electronically to
(Pub. L. 98–417) and the Generic Intercept Blood System for Platelets is https://www.regulations.gov at Docket
Animal Drug and Patent Term 7,080 days. Of this time, 6,909 days No. FDA–2013–S–0610. Submit written
Restoration Act (Pub. L. 100–670) occurred during the testing phase of the petitions (two copies are required) to the
generally provide that a patent may be regulatory review period, while 171 Dockets Management Staff (see
extended for a period of up to 5 years days occurred during the approval ADDRESSES).
so long as the patented item (human phase. These periods of time were
Dated: July 5, 2017.
drug product, animal drug product, derived from the following dates:
1. The date an exemption under Anna K. Abram,
medical device, food additive, or color Deputy Commissioner for Policy, Planning,
section 520(g) of the Federal Food, Drug,
additive) was subject to regulatory Legislation, and Analysis.
and Cosmetic Act (the FD&C Act) (21
review by FDA before the item was
U.S.C. 360j(g)) involving this device [FR Doc. 2017–14455 Filed 7–10–17; 8:45 am]
marketed. Under these acts, a product’s
became effective: August 2, 1995. The BILLING CODE 4164–01–P
regulatory review period forms the basis
applicant claims that the investigational
for determining the amount of extension
device exemption (IDE) required under
an applicant may receive. DEPARTMENT OF HEALTH AND
section 520(g) of the FD&C Act for
A regulatory review period consists of HUMAN SERVICES
human tests to begin became effective
two periods of time: A testing phase and
on July 26, 1995. However, FDA records
an approval phase. For medical devices, Food and Drug Administration
indicate that the IDE was determined
the testing phase begins with a clinical
substantially complete for clinical [Docket No. FDA–2017–N–2166]
investigation of the device and runs
studies to have begun on August 2,
until the approval phase begins. The Draft Standardization of
1995, which represents the IDE effective
approval phase starts with the initial Pharmaceutical Quality/Chemistry
date.
submission of an application to market 2. The date an application was Manufacturing and Control Data
the device and continues until FDA initially submitted with respect to the Elements and Terminologies; Request
grants permission to market the device. device under section 515 of the FD&C for Comments
Although only a portion of a regulatory Act (21 U.S.C. 360e): July 1, 2014. The
review period may count toward the AGENCY: Food and Drug Administration,
applicant claims August 15, 2014, as the
actual amount of extension that the HHS.
date the premarket approval application
Director of USPTO may award (for (PMA) for Intercept Blood System for ACTION: Notice; request for comments.
example, half the testing phase must be Platelets (PMA BP140143) was initially
subtracted as well as any time that may SUMMARY: The Food and Drug
submitted. However, FDA records Administration (FDA or Agency) is
have occurred before the patent was indicate that the complete PMA
issued), FDA’s determination of the requesting comment on the draft
BP140143 was submitted on July 1, standardized Pharmaceutical Quality/
length of a regulatory review period for 2014.
a medical device will include all of the Chemistry Manufacturing and Control
3. The date the application was
testing phase and approval phase as (PQ/CMC) data elements and
approved: December 18, 2014. FDA has
specified in 35 U.S.C. 156(g)(3)(B). terminologies for the electronic
verified the applicant’s claims that PMA
FDA has approved for marketing the submission of PQ/CMC data. The
BP140143 was approved on December
medical device Intercept Blood System establishment of standardized
18, 2014.
for Platelets. Intercept Blood System for This determination of the regulatory pharmaceutical quality data elements
Platelets is indicated for ex vivo review period establishes the maximum and terminologies will provide
preparation of apheresis platelet potential length of a patent extension. opportunities for FDA and industry to
components in order to reduce the risk However, the USPTO applies several transform PQ/CMC submission data into
of transfusion-transmitted infection statutory limitations in its calculations a readily useable electronic format. As
including sepsis, and to potentially of the actual period for patent extension. a result, these established data elements
reduce the risk of transfusion-associated In its applications for patent extension, and terminologies will improve the
graft versus host disease. Subsequent to this applicant seeks 1,640 days or 999 efficiency and quality of the drug review
this approval, the USPTO received days of patent term extension. process. The Agency is seeking
patent term restoration applications for comment on the accuracy, suitability,
Intercept Blood System for Platelets III. Petitions and appropriateness of these data
(U.S. Patent Nos. 7,037,642 and Anyone with knowledge that any of elements and terminologies for
7,611,831) from Cerus Corporation, and the dates as published are incorrect may submission of PQ/CMC data. FDA is
the USPTO requested FDA’s assistance submit either electronic or written considering implementing PQ/CMC
in determining the patents’ eligibility comments and, under 21 CFR 60.24, ask requirements as a Health Level 7 (HL7)
for patent term restoration. In a letter for a redetermination (see DATES). Structured Product Labeling (SPL)
mstockstill on DSK30JT082PROD with NOTICES
dated April 29, 2016, FDA advised the Furthermore, as specified in 21 CFR document. The proposed data elements
USPTO that this medical device had 60.30, any interested person may and terminologies can be obtained on
undergone a regulatory review period petition FDA for a determination https://www.regulations.gov in Docket
and that the approval of Intercept Blood regarding whether the applicant for No. FDA–2017–N–2166.
System for Platelets represented the first extension acted with due diligence DATES: Submit either electronic or
permitted commercial marketing or use during the regulatory review period. To written comments by September 11,
of the product. Thereafter, the USPTO meet its burden, the petition must be 2017. Late, untimely filed comments
VerDate Sep<11>2014 18:01 Jul 10, 2017 Jkt 241001 PO 00000 Frm 00071 Fmt 4703 Sfmt 4703 E:\FR\FM\11JYN1.SGM 11JYN1](https://thefederalregister.org/doc/82_FR_32134/page/1.svg)
![32004 Federal Register / Vol. 82, No. 131 / Tuesday, July 11, 2017 / Notices
will not be considered. Electronic for Comments.’’ Received comments, and Drug Administration, 7500 Standish
comments must be submitted on or those filed in a timely manner (see Pl. (HFV–143), Rockville, MD 20855,
before September 11, 2017. The https:// DATES), will be placed in the docket and, 240–402–0684; or Michael Kerrigan,
www.regulations.gov electronic filing except for those submitted as Center for Veterinary Medicine, Food
system will accept comments until ‘‘Confidential Submissions,’’ publicly and Drug Administration, 7500 Standish
midnight Eastern Time at the end of viewable at https://www.regulations.gov Pl. (HFV–143), Rockville, MD 20855,
September 11, 2017. Comments received or at the Dockets Management Staff 240–402–0644. Alternatively, send
by mail/hand delivery/courier (for between 9 a.m. and 4 p.m., Monday questions to the PQ–CMC mailbox: PQ–
written/paper submissions) will be through Friday. CMC@fda.hhs.gov.
considered timely if they are • Confidential Submissions—To
postmarked or the delivery service SUPPLEMENTARY INFORMATION:
submit a comment with confidential
acceptance receipt is on or before that information that you do not wish to be I. Background
date. made publicly available, submit your
ADDRESSES: You may submit comments comments only as a written/paper PQ/CMC is a term used to describe
as follows: submission. You should submit two manufacturing and testing data of
copies total. One copy will include the pharmaceutical products. PQ/CMC
Electronic Submissions
information you claim to be confidential encompasses topics such as drug
Submit electronic comments in the with a heading or cover note that states stability, quality specification, and
following way: ‘‘THIS DOCUMENT CONTAINS batch analysis, which are important
• Federal eRulemaking Portal: CONFIDENTIAL INFORMATION.’’ The aspects of drug development. PQ/CMC
https://www.regulations.gov. Follow the Agency will review this copy, including plays an integral part in the regulatory
instructions for submitting comments. the claimed confidential information, in review process and life cycle
Comments submitted electronically, its consideration of comments. The management of pharmaceutical
including attachments, to https:// second copy, which will have the products. The standardization of PQ/
www.regulations.gov will be posted to claimed confidential information CMC data elements and terminologies
the docket unchanged. Because your redacted/blacked out, will be available will facilitate the Agency’s transition to
comment will be made public, you are for public viewing and posted on an electronic review environment.
solely responsible for ensuring that your https://www.regulations.gov. Submit
comment does not include any FDA intends to identify and
both copies to the Dockets Management standardize data elements and
confidential information that you or a Staff. If you do not wish your name and
third party may not wish to be posted, terminologies for information
contact information to be made publicly commonly used and submitted in
such as medical information, your or available, you can provide this
anyone else’s Social Security number, or support of drug product applications.
information on the cover sheet and not The impetus for this standardization
confidential business information, such in the body of your comments and you
as a manufacturing process. Please note effort was the provisions from the 2012
must identify this information as Food and Drug Administration Safety
that if you include your name, contact ‘‘confidential.’’ Any information marked
information, or other information that and Innovation Act (FDASIA) (Pub. L.
as ‘‘confidential’’ will not be disclosed
identifies you in the body of your 112–144), which authorized the Agency
except in accordance with 21 CFR 10.20
comments, that information will be to require certain submissions to be in
and other applicable disclosure law. For
posted on https://www.regulations.gov. a specified electronic format. The
more information about FDA’s posting
• If you want to submit a comment of comments to public dockets, see 80
development of a structured format for
with confidential information that you PQ/CMC data will enable consistency in
FR 56469, September 18, 2015, or access
do not wish to be made available to the the content and format of PQ/CMC data
the information at: https://www.gpo.gov/
public, submit the comment as a submitted, thus providing a harmonized
fdsys/pkg/FR-2015-09-18/pdf/2015-
written/paper submission and in the language for submission content,
23389.pdf.
manner detailed (see ‘‘Written/Paper allowing reviewers to query the data,
Docket: For access to the docket to
Submissions’’ and ‘‘Instructions’’). and, in general, contributing to a more
read background documents or the
electronic and written/paper comments efficient and effective regulatory
Written/Paper Submissions decision-making process by creating a
Submit written/paper submissions as received, go to https://
www.regulations.gov and insert the standardized data dictionary.
follows:
docket number, found in brackets in the After receiving comments, the Agency
• Mail/Hand delivery/Courier (for
heading of this document, into the will consider future actions on the
written/paper submissions): Dockets
Management Staff (HFA–305), Food and ‘‘Search’’ box and follow the prompts standardization of PQ/CMC data
Drug Administration, 5630 Fishers and/or go to the Dockets Management elements and terminologies for
Lane, Rm. 1061, Rockville, MD 20852. Staff, 5630 Fishers Lane, Rm. 1061, electronic submissions.
• For written/paper comments Rockville, MD 20852.
II. Electronic Access
submitted to the Dockets Management FOR FURTHER INFORMATION CONTACT:
Staff, FDA will post your comment, as Norman Schmuff, Center for Drug Persons with access to the Internet
well as any attachments, except for Evaluation and Research, Food and may obtain the proposed data elements
information submitted, marked and Drug Administration, 10903 New and terminologies at https://
identified, as confidential, if submitted Hampshire Ave., Bldg. 21, Rm. 2526, www.regulations.gov.
mstockstill on DSK30JT082PROD with NOTICES
as detailed in ‘‘Instructions.’’ Silver Spring, MD 20993–0002, 301–
Dated: July 5, 2017.
Instructions: All submissions received 796–1454; Stephen Ripley, Center for
must include the Docket No. FDA– Biologics Evaluation and Research, Anna K. Abram,
2017–N–2166 for ‘‘Draft Standardization Food and Drug Administration, Bldg. Deputy Commissioner for Policy, Planning,
of Pharmaceutical Quality/Chemistry 71, Rm. 7301, Silver Spring, MD 20993– Legislation, and Analysys.
Manufacturing and Control Data 0002, 240–402–7911; Norman Gregory, [FR Doc. 2017–14456 Filed 7–10–17; 8:45 am]
Elements and Terminologies; Request Center for Veterinary Medicine, Food BILLING CODE 4164–01–P
VerDate Sep<11>2014 18:01 Jul 10, 2017 Jkt 241001 PO 00000 Frm 00072 Fmt 4703 Sfmt 9990 E:\FR\FM\11JYN1.SGM 11JYN1](https://thefederalregister.org/doc/82_FR_32134/page/2.svg)
Document Created: 2018-11-14 10:21:27
Document Modified: 2018-11-14 10:21:27
| 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; request for comments. | |
| Dates | Submit either electronic or written comments by September 11, 2017. Late, untimely filed comments will not be considered. Electronic comments must be submitted on or before September 11, 2017. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of September 11, 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 | Norman Schmuff, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 21, Rm. 2526, Silver Spring, MD 20993-0002, 301- 796-1454; Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911; Norman Gregory, Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Pl. (HFV-143), Rockville, MD 20855, 240-402-0684; or Michael Kerrigan, Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Pl. (HFV-143), Rockville, MD 20855, 240-402-0644. Alternatively, send questions to the PQ-CMC mailbox: [email protected] | |
| FR Citation | 82 FR 32003 |
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